Clinical Trials List
Protocol NumberGO43860
NCT Number(ClinicalTrials.gov Identfier)NCT05581004
Active
2025-04-01 - 2027-11-30
Phase I
Recruiting3
A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7502175 as a Single Agent and in Combination With Checkpoint Inhibitor in Participants With Locally Advanced or Metastatic Solid Tumors
-
Sponsor
PPD, Inc. Taiwan Branch
-
Trial scale
Multi-Regional Multi-Center
-
Update
2026/02/01
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 吳宗哲 Division of Hematology & Oncology
- 梁逸歆 Division of Hematology & Oncology
- James Chih-Hsin Yang Division of Hematology & Oncology
- CHAO-CHI HO CHAO-CHI HO Division of General Internal Medicine
- 徐偉勛 醫學研究部
- HUAI-CHENG HUANG Division of Hematology & Oncology
- 廖斌志 Division of Hematology & Oncology
- JIN-YUAN SHIH Division of General Internal Medicine
- 陳國興 Division of Hematology & Oncology
- 廖唯昱 Division of General Internal Medicine
- Jih-Hsiang Lee Division of Hematology & Oncology
- Wei-Wu Chen Division of Hematology & Oncology
- Kun-Huei Yeh Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Jen-Yu Hung
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Locally advanced or metastatic solid tumor
Objectives
This study is a Phase Ia/Ib, open-label, multicenter, dose-escalation trial designed to evaluate the safety, pharmacokinetics, and activity of RO7502175 administered as monotherapy and in combination with a checkpoint inhibitor in patients with locally advanced or metastatic solid tumors.
Test Drug
RO7502175
RO7502175 diluent
Atezolizumab
Pembrolizumab
RO7502175 diluent
Atezolizumab
Pembrolizumab
Active Ingredient
RO7502175
RO7502175 diluent
Atezolizumab
Pembrolizumab
RO7502175 diluent
Atezolizumab
Pembrolizumab
Dosage Form
270
270
270
270
270
270
270
Dosage
170mg/3.4ml
0 mg/5 ml
1200mg/20mL
100mg/4mL
0 mg/5 ml
1200mg/20mL
100mg/4mL
Endpoints
To evaluate the safety of RO7502175 when administered as monotherapy (Phase Ia) or in combination with atezolizumab or pembrolizumab (Phase Ib), including the characterization of dose-limiting toxicities (DLTs).
Inclution Criteria
General Inclusion Criteria:
Informed Consent:
• Ability to understand and willingness to sign a written informed consent form prior to any study-related procedures.
Age:
• ≥18 years at the time of signing informed consent.
Compliance:
• Ability, in the investigator’s opinion, to comply with all protocol requirements.
Performance Status:
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Life Expectancy:
• Estimated life expectancy ≥12 weeks.
Adequate Hematologic and Organ Function:
Laboratory and diagnostic assessments obtained within 14 days before initiation of study treatment must meet the following criteria:
– Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L (≥ 1500/μL) without granulocyte colony-stimulating factor (G-CSF) support, except:
• Patients with benign ethnic neutropenia (BEN): ANC > 1.3 × 10⁹/L (1300/μL).
> BEN (also known as constitutional neutropenia) is a mild-to-moderate hereditary reduction in neutrophil counts, commonly seen in individuals of African or certain ethnic descent, not associated with increased infection risk or other clinical complications.
– Lymphocyte count ≥ 0.5 × 10⁹/L (≥ 500/μL).
– Platelet count ≥ 100 × 10⁹/L (≥ 100,000/μL), with no transfusion within 14 days prior to Cycle 1 Day 1.
– Hemoglobin ≥ 90 g/L (≥ 9 g/dL).
Note: Patients may receive transfusions or erythropoietic support per local standard of care.
– AST, ALT, and ALP ≤ 2.5 × ULN, except:
• Patients with liver metastases: AST and ALT ≤ 5 × ULN.
• Patients with liver or bone metastases: ALP ≤ 5 × ULN.
– Total bilirubin ≤ 1.5 × ULN, except:
• Patients with documented Gilbert’s syndrome: ≤ 3 × ULN.
– Creatinine clearance ≥ 50 mL/min, measured or estimated using the Cockcroft-Gault formula:
CrCl
=
(
140
−
age
)
×
weight (kg)
×
(
0.85
if female
)
72
×
serum creatinine (mg/dL)
CrCl=
72×serum creatinine (mg/dL)
(140−age)×weight (kg)×(0.85 if female)
– Albumin ≥ 25 g/L (2.5 g/dL).
– For patients not receiving anticoagulation: INR and aPTT ≤ 1.5 × ULN.
Patients on anticoagulant therapy should be on a stable regimen.
Disease Confirmation:
• Histologically confirmed, locally advanced, recurrent, or metastatic incurable malignant solid tumor.
• Additional disease- or therapy-specific requirements for each cohort will be detailed in the protocol.
Tumor Tissue Availability:
• Availability of a representative formalin-fixed, paraffin-embedded (FFPE) tumor tissue block (preferred) or ≥15 unstained slides, plus corresponding pathology report.
• Patients are eligible if archival tissue is unavailable or insufficient, provided they can:
– Submit ≥10 unstained slides; or
– Consent to a pre-treatment biopsy; or
– Are enrolled in a dose-escalation cohort.
• Expansion cohort patients must provide archival tissue; dose-escalation patients should provide it if available.
• If multiple tissue samples are available (e.g., at diagnosis and recurrence/metastasis), the most recent post-systemic-therapy sample should be prioritized.
Measurable Disease:
• At least one measurable lesion per RECIST v1.1.
• Lesions previously irradiated should not be selected as target lesions unless progression is confirmed and no other measurable lesions are available.
• Biopsy-targeted lesions or CNS lesions should not be selected as target lesions.
Women of Childbearing Potential (WOCBP):
• Must agree to remain abstinent (avoid heterosexual intercourse) or use effective contraception and refrain from donating oocytes during:
– Treatment and for ≥4 months after the last dose of RO7502175,
– ≥4 months after the last dose of pembrolizumab, or
– ≥5 months after the last dose of atezolizumab,
whichever is longer.
• Highly effective contraception (<1% failure rate per year) includes:
– Bilateral tubal ligation, male sterilization, hormonal contraception suppressing ovulation, hormone-releasing or copper IUDs.
Hormonal contraception must be combined with a barrier method.
• Periodic abstinence (calendar, ovulation, symptom-based, or withdrawal methods) is not acceptable.
Men:
• Must agree to remain abstinent (avoid heterosexual intercourse) or use a condom and refrain from donating sperm:
– During treatment and for 4 months after the last dose of RO7502175.
• If the partner is pregnant or of childbearing potential, a condom must be used to avoid drug exposure to the embryo/fetus.
• Periodic abstinence and withdrawal are not acceptable methods.
Informed Consent:
• Ability to understand and willingness to sign a written informed consent form prior to any study-related procedures.
Age:
• ≥18 years at the time of signing informed consent.
Compliance:
• Ability, in the investigator’s opinion, to comply with all protocol requirements.
Performance Status:
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Life Expectancy:
• Estimated life expectancy ≥12 weeks.
Adequate Hematologic and Organ Function:
Laboratory and diagnostic assessments obtained within 14 days before initiation of study treatment must meet the following criteria:
– Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L (≥ 1500/μL) without granulocyte colony-stimulating factor (G-CSF) support, except:
• Patients with benign ethnic neutropenia (BEN): ANC > 1.3 × 10⁹/L (1300/μL).
> BEN (also known as constitutional neutropenia) is a mild-to-moderate hereditary reduction in neutrophil counts, commonly seen in individuals of African or certain ethnic descent, not associated with increased infection risk or other clinical complications.
– Lymphocyte count ≥ 0.5 × 10⁹/L (≥ 500/μL).
– Platelet count ≥ 100 × 10⁹/L (≥ 100,000/μL), with no transfusion within 14 days prior to Cycle 1 Day 1.
– Hemoglobin ≥ 90 g/L (≥ 9 g/dL).
Note: Patients may receive transfusions or erythropoietic support per local standard of care.
– AST, ALT, and ALP ≤ 2.5 × ULN, except:
• Patients with liver metastases: AST and ALT ≤ 5 × ULN.
• Patients with liver or bone metastases: ALP ≤ 5 × ULN.
– Total bilirubin ≤ 1.5 × ULN, except:
• Patients with documented Gilbert’s syndrome: ≤ 3 × ULN.
– Creatinine clearance ≥ 50 mL/min, measured or estimated using the Cockcroft-Gault formula:
CrCl
=
(
140
−
age
)
×
weight (kg)
×
(
0.85
if female
)
72
×
serum creatinine (mg/dL)
CrCl=
72×serum creatinine (mg/dL)
(140−age)×weight (kg)×(0.85 if female)
– Albumin ≥ 25 g/L (2.5 g/dL).
– For patients not receiving anticoagulation: INR and aPTT ≤ 1.5 × ULN.
Patients on anticoagulant therapy should be on a stable regimen.
Disease Confirmation:
• Histologically confirmed, locally advanced, recurrent, or metastatic incurable malignant solid tumor.
• Additional disease- or therapy-specific requirements for each cohort will be detailed in the protocol.
Tumor Tissue Availability:
• Availability of a representative formalin-fixed, paraffin-embedded (FFPE) tumor tissue block (preferred) or ≥15 unstained slides, plus corresponding pathology report.
• Patients are eligible if archival tissue is unavailable or insufficient, provided they can:
– Submit ≥10 unstained slides; or
– Consent to a pre-treatment biopsy; or
– Are enrolled in a dose-escalation cohort.
• Expansion cohort patients must provide archival tissue; dose-escalation patients should provide it if available.
• If multiple tissue samples are available (e.g., at diagnosis and recurrence/metastasis), the most recent post-systemic-therapy sample should be prioritized.
Measurable Disease:
• At least one measurable lesion per RECIST v1.1.
• Lesions previously irradiated should not be selected as target lesions unless progression is confirmed and no other measurable lesions are available.
• Biopsy-targeted lesions or CNS lesions should not be selected as target lesions.
Women of Childbearing Potential (WOCBP):
• Must agree to remain abstinent (avoid heterosexual intercourse) or use effective contraception and refrain from donating oocytes during:
– Treatment and for ≥4 months after the last dose of RO7502175,
– ≥4 months after the last dose of pembrolizumab, or
– ≥5 months after the last dose of atezolizumab,
whichever is longer.
• Highly effective contraception (<1% failure rate per year) includes:
– Bilateral tubal ligation, male sterilization, hormonal contraception suppressing ovulation, hormone-releasing or copper IUDs.
Hormonal contraception must be combined with a barrier method.
• Periodic abstinence (calendar, ovulation, symptom-based, or withdrawal methods) is not acceptable.
Men:
• Must agree to remain abstinent (avoid heterosexual intercourse) or use a condom and refrain from donating sperm:
– During treatment and for 4 months after the last dose of RO7502175.
• If the partner is pregnant or of childbearing potential, a condom must be used to avoid drug exposure to the embryo/fetus.
• Periodic abstinence and withdrawal are not acceptable methods.
Exclusion Criteria
General Exclusion Criteria
Pregnancy/lactation: Pregnant, breastfeeding, or intending to become pregnant during the study or within 4 months after the last dose of RO7502175 or pembrolizumab, or 5 months after the last dose of atezolizumab (whichever is longer).
• Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to first study drug.
Recent anticancer therapy (within 3 weeks before first dose), investigational or approved, including chemotherapy, hormonal therapy, and/or radiotherapy, except:
• Hormone replacement therapy or oral contraceptives.
• TKIs approved for cancer that were stopped >7 days before Cycle 1 Day 1 (C1D1); baseline scans must be obtained after stopping the prior TKI, and prior-therapy–related AEs must meet protocol criteria.
• Herbal anticancer therapies stopped >7 days before C1D1.
• Palliative radiotherapy for painful or anatomically sensitive metastases (e.g., epidural) completed >2 weeks before C1D1.
Cancer vaccines within 6 weeks before first study treatment or 5 drug half-lives (whichever is shorter).
Systemic immunostimulants (e.g., IFN, IL-2) within 4 weeks before first study treatment or 5 half-lives (whichever is longer), and during study treatment.
Prior T-reg–depleting agents, including but not limited to CD25-targeted (e.g., RO7296682, basiliximab), CCR4-targeted (e.g., mogamulizumab), or CCR8-targeted therapies (e.g., BMS-986340, GS-1811); except RO7502175 received in the Phase Ia portion by patients rolling into Phase Ib.
CNS metastases that are symptomatic, untreated, or progressing.
Asymptomatic, treated CNS lesions are eligible if all of the following apply:
• Measurable extracranial disease per RECIST v1.1.
• No acute/subacute hemorrhage related to brain metastases on screening imaging.
• No stereotactic radiotherapy within 7 days, no whole-brain radiotherapy within 14 days, and no neurosurgical resection within 28 days prior to first study treatment.
• No ongoing corticosteroids for CNS disease; corticosteroids stopped ≥2 weeks before enrollment. Stable antiepileptics are allowed.
• No evidence of interval progression between completion of CNS-directed therapy and start of study treatment.
• Metastases confined to cerebellum or supratentorial regions (i.e., none in midbrain, pons, medulla, or spinal cord).
Note: Newly detected, asymptomatic CNS metastases at screening may become eligible after radiotherapy or surgery without repeating screening brain imaging.
Leptomeningeal disease history.
Spinal cord compression without definitive surgery and/or radiotherapy, or previously treated compression not clinically stable ≥2 weeks prior to screening.
Major cardiovascular disease within 3 months before first study treatment (e.g., NYHA class II or higher heart disease, myocardial infarction, stroke), unstable arrhythmias, or unstable angina.
QTcF > 470 ms (mean of three ECGs).
Any condition (disease, metabolic dysfunction, physical exam finding, or lab abnormality) that contraindicates investigational therapy, confounds interpretation, or increases risk of complications, including but not limited to:
• Clinically significant liver disease (active viral/alcoholic/other hepatitis, cirrhosis, hereditary liver disorders) or current alcohol abuse.
• Poorly controlled type 2 diabetes: HbA1c ≥ 8% or fasting plasma glucose ≥ 160 mg/dL (8.8 mmol/L).
• Severe dyspnea or resting oxygen requirement.
• History of Stevens–Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), or DRESS.
• Current or prior wound-healing complications and/or non-healed open wounds, unless attributed to underlying tumor per investigator.
Uncontrolled tumor-related pain. Patients requiring analgesics must be on a stable dose at entry.
• Symptomatic lesions amenable to palliative radiotherapy (e.g., bone metastases, nerve-compressing lesions) should be treated before enrollment with recovery from RT effects.
• Consider local therapy before enrollment for asymptomatic lesions likely to cause functional compromise or refractory pain as they progress (e.g., epidural lesions without current cord compression).
Symptomatic pleural/pericardial effusion or ascites, or any procedure for these conditions within 6 weeks before C1D1.
• Indwelling catheters (e.g., PleurX®) are allowed.
Uncontrolled or symptomatic hypercalcemia (e.g., ionized Ca > 1.5 mmol/L; total Ca > 12 mg/dL; or corrected Ca > ULN).
Malignancy (other than the disease under study) within 3 years before screening, except cancers with negligible risk of metastasis or death (e.g., 5-year OS >90%) such as adequately treated cervical carcinoma in situ, non-melanoma skin cancer, localized prostate cancer, ductal carcinoma in situ, or Stage I endometrial cancer.
Unresolved toxicities from prior anticancer therapy > Grade 1 (permitted: alopecia, vitiligo, and endocrine disorders controlled with replacement therapy).
• Immune-related AEs (irAEs) exceptions detailed below.
Prior immunotherapy–related:
• Any Grade 4 irAE (except endocrine disorders manageable with replacement, or asymptomatic lipase elevation).
• Grade 2 immune-mediated myocarditis.
• Any Grade 3 irAE that led to permanent discontinuation of prior immunotherapy, or occurred ≤ 6 months before planned C1D1 (except endocrine disorders on replacement, or asymptomatic lipase elevation).
• Any ongoing irAE (other than controlled endocrine disorders or stable vitiligo) not resolved to baseline.
– If corticosteroids were used for an irAE, patient must be symptom-free ≥4 weeks after steroid discontinuation.
Autoimmune disease or immunodeficiency (current or past), including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, SLE, rheumatoid arthritis, IBD, antiphospholipid syndrome, Wegener’s granulomatosis, Sjögren’s syndrome, Guillain–Barré syndrome, multiple sclerosis.
Allowed exceptions:
• Autoimmune hypothyroidism on stable replacement therapy.
• Type 1 diabetes controlled on insulin.
• Dermatologic-only conditions (eczema, psoriasis, chronic lichen simplex, vitiligo; exclude psoriatic arthritis) if all:
– <10% body surface area involved,
– Well controlled at baseline requiring only low-potency topical steroids,
– No flare requiring PUVA, methotrexate, retinoids, biologics, oral calcineurin inhibitors, or high-potency/systemic steroids in the past 12 months.
History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT.
• Radiation pneumonitis (fibrosis) limited to prior radiation fields is allowed.
Active tuberculosis.
Serious infection within 4 weeks before first study treatment, including hospitalization for infectious complications, bacteremia, or severe pneumonia requiring IV antibiotics.
Signs/symptoms of non-serious infection or oral antibiotics within 1 week before first study treatment.
• Prophylactic antibiotics (e.g., for UTI prevention or COPD exacerbation prophylaxis) are allowed.
HIV positive test.
Hepatitis B: Positive HBsAg and/or total anti-HBc at screening.
Note: Subjects with total anti-HBc positive and HBV DNA negative at screening may be included. Antiviral prophylaxis is allowed for subjects at risk of HBV reactivation.
Hepatitis C: Anti-HCV positive at screening.
• Eligible if HCV RNA (PCR) is negative.
Acute or chronic active Epstein–Barr virus (EBV) infection at screening.
• Assess EBV status via serology (e.g., VCA IgM/IgG). If symptomatic or serology suggests recent active infection (VCA IgM+), an EBV PCR (plasma/serum) must show undetectable EBV to qualify.
Active, symptomatic SARS-CoV-2 infection within 14 days prior to first study treatment, or requiring IV antivirals (excluding primary prophylaxis).
• Symptomatic patients must have two negative antigen tests on separate days ≥1 day before starting treatment.
Live attenuated vaccine within 4 weeks prior to first RO7502175 infusion, or planned during the study or within 5 months after the last study treatment (e.g., FluMist®).
Systemic immunosuppressants within 2 weeks before first study treatment (e.g., corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, anti–TNF-α), or anticipated need during treatment, except:
• Acute, low-dose systemic immunosuppression or single-pulse premedication (e.g., 48-hour corticosteroids for contrast allergy).
• Mineralocorticoids (e.g., fludrocortisone), inhaled steroids for COPD/asthma, or low-dose steroids for orthostatic hypotension or adrenal insufficiency.
Major surgery or significant trauma within 28 days before first study drug, or anticipated need for major surgery before end of treatment. Start treatment only after complete wound healing.
Prior allogeneic stem-cell or solid organ transplant.
Severe hypersensitivity to chimeric or humanized antibodies or fusion proteins.
Known hypersensitivity to Chinese hamster ovary (CHO)–derived products or any component of the atezolizumab formulation.
Known hypersensitivity or allergy to pembrolizumab.
Known hypersensitivity or allergy to any component of the RO7502175 formulation.
Pregnancy/lactation: Pregnant, breastfeeding, or intending to become pregnant during the study or within 4 months after the last dose of RO7502175 or pembrolizumab, or 5 months after the last dose of atezolizumab (whichever is longer).
• Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to first study drug.
Recent anticancer therapy (within 3 weeks before first dose), investigational or approved, including chemotherapy, hormonal therapy, and/or radiotherapy, except:
• Hormone replacement therapy or oral contraceptives.
• TKIs approved for cancer that were stopped >7 days before Cycle 1 Day 1 (C1D1); baseline scans must be obtained after stopping the prior TKI, and prior-therapy–related AEs must meet protocol criteria.
• Herbal anticancer therapies stopped >7 days before C1D1.
• Palliative radiotherapy for painful or anatomically sensitive metastases (e.g., epidural) completed >2 weeks before C1D1.
Cancer vaccines within 6 weeks before first study treatment or 5 drug half-lives (whichever is shorter).
Systemic immunostimulants (e.g., IFN, IL-2) within 4 weeks before first study treatment or 5 half-lives (whichever is longer), and during study treatment.
Prior T-reg–depleting agents, including but not limited to CD25-targeted (e.g., RO7296682, basiliximab), CCR4-targeted (e.g., mogamulizumab), or CCR8-targeted therapies (e.g., BMS-986340, GS-1811); except RO7502175 received in the Phase Ia portion by patients rolling into Phase Ib.
CNS metastases that are symptomatic, untreated, or progressing.
Asymptomatic, treated CNS lesions are eligible if all of the following apply:
• Measurable extracranial disease per RECIST v1.1.
• No acute/subacute hemorrhage related to brain metastases on screening imaging.
• No stereotactic radiotherapy within 7 days, no whole-brain radiotherapy within 14 days, and no neurosurgical resection within 28 days prior to first study treatment.
• No ongoing corticosteroids for CNS disease; corticosteroids stopped ≥2 weeks before enrollment. Stable antiepileptics are allowed.
• No evidence of interval progression between completion of CNS-directed therapy and start of study treatment.
• Metastases confined to cerebellum or supratentorial regions (i.e., none in midbrain, pons, medulla, or spinal cord).
Note: Newly detected, asymptomatic CNS metastases at screening may become eligible after radiotherapy or surgery without repeating screening brain imaging.
Leptomeningeal disease history.
Spinal cord compression without definitive surgery and/or radiotherapy, or previously treated compression not clinically stable ≥2 weeks prior to screening.
Major cardiovascular disease within 3 months before first study treatment (e.g., NYHA class II or higher heart disease, myocardial infarction, stroke), unstable arrhythmias, or unstable angina.
QTcF > 470 ms (mean of three ECGs).
Any condition (disease, metabolic dysfunction, physical exam finding, or lab abnormality) that contraindicates investigational therapy, confounds interpretation, or increases risk of complications, including but not limited to:
• Clinically significant liver disease (active viral/alcoholic/other hepatitis, cirrhosis, hereditary liver disorders) or current alcohol abuse.
• Poorly controlled type 2 diabetes: HbA1c ≥ 8% or fasting plasma glucose ≥ 160 mg/dL (8.8 mmol/L).
• Severe dyspnea or resting oxygen requirement.
• History of Stevens–Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), or DRESS.
• Current or prior wound-healing complications and/or non-healed open wounds, unless attributed to underlying tumor per investigator.
Uncontrolled tumor-related pain. Patients requiring analgesics must be on a stable dose at entry.
• Symptomatic lesions amenable to palliative radiotherapy (e.g., bone metastases, nerve-compressing lesions) should be treated before enrollment with recovery from RT effects.
• Consider local therapy before enrollment for asymptomatic lesions likely to cause functional compromise or refractory pain as they progress (e.g., epidural lesions without current cord compression).
Symptomatic pleural/pericardial effusion or ascites, or any procedure for these conditions within 6 weeks before C1D1.
• Indwelling catheters (e.g., PleurX®) are allowed.
Uncontrolled or symptomatic hypercalcemia (e.g., ionized Ca > 1.5 mmol/L; total Ca > 12 mg/dL; or corrected Ca > ULN).
Malignancy (other than the disease under study) within 3 years before screening, except cancers with negligible risk of metastasis or death (e.g., 5-year OS >90%) such as adequately treated cervical carcinoma in situ, non-melanoma skin cancer, localized prostate cancer, ductal carcinoma in situ, or Stage I endometrial cancer.
Unresolved toxicities from prior anticancer therapy > Grade 1 (permitted: alopecia, vitiligo, and endocrine disorders controlled with replacement therapy).
• Immune-related AEs (irAEs) exceptions detailed below.
Prior immunotherapy–related:
• Any Grade 4 irAE (except endocrine disorders manageable with replacement, or asymptomatic lipase elevation).
• Grade 2 immune-mediated myocarditis.
• Any Grade 3 irAE that led to permanent discontinuation of prior immunotherapy, or occurred ≤ 6 months before planned C1D1 (except endocrine disorders on replacement, or asymptomatic lipase elevation).
• Any ongoing irAE (other than controlled endocrine disorders or stable vitiligo) not resolved to baseline.
– If corticosteroids were used for an irAE, patient must be symptom-free ≥4 weeks after steroid discontinuation.
Autoimmune disease or immunodeficiency (current or past), including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, SLE, rheumatoid arthritis, IBD, antiphospholipid syndrome, Wegener’s granulomatosis, Sjögren’s syndrome, Guillain–Barré syndrome, multiple sclerosis.
Allowed exceptions:
• Autoimmune hypothyroidism on stable replacement therapy.
• Type 1 diabetes controlled on insulin.
• Dermatologic-only conditions (eczema, psoriasis, chronic lichen simplex, vitiligo; exclude psoriatic arthritis) if all:
– <10% body surface area involved,
– Well controlled at baseline requiring only low-potency topical steroids,
– No flare requiring PUVA, methotrexate, retinoids, biologics, oral calcineurin inhibitors, or high-potency/systemic steroids in the past 12 months.
History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT.
• Radiation pneumonitis (fibrosis) limited to prior radiation fields is allowed.
Active tuberculosis.
Serious infection within 4 weeks before first study treatment, including hospitalization for infectious complications, bacteremia, or severe pneumonia requiring IV antibiotics.
Signs/symptoms of non-serious infection or oral antibiotics within 1 week before first study treatment.
• Prophylactic antibiotics (e.g., for UTI prevention or COPD exacerbation prophylaxis) are allowed.
HIV positive test.
Hepatitis B: Positive HBsAg and/or total anti-HBc at screening.
Note: Subjects with total anti-HBc positive and HBV DNA negative at screening may be included. Antiviral prophylaxis is allowed for subjects at risk of HBV reactivation.
Hepatitis C: Anti-HCV positive at screening.
• Eligible if HCV RNA (PCR) is negative.
Acute or chronic active Epstein–Barr virus (EBV) infection at screening.
• Assess EBV status via serology (e.g., VCA IgM/IgG). If symptomatic or serology suggests recent active infection (VCA IgM+), an EBV PCR (plasma/serum) must show undetectable EBV to qualify.
Active, symptomatic SARS-CoV-2 infection within 14 days prior to first study treatment, or requiring IV antivirals (excluding primary prophylaxis).
• Symptomatic patients must have two negative antigen tests on separate days ≥1 day before starting treatment.
Live attenuated vaccine within 4 weeks prior to first RO7502175 infusion, or planned during the study or within 5 months after the last study treatment (e.g., FluMist®).
Systemic immunosuppressants within 2 weeks before first study treatment (e.g., corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, anti–TNF-α), or anticipated need during treatment, except:
• Acute, low-dose systemic immunosuppression or single-pulse premedication (e.g., 48-hour corticosteroids for contrast allergy).
• Mineralocorticoids (e.g., fludrocortisone), inhaled steroids for COPD/asthma, or low-dose steroids for orthostatic hypotension or adrenal insufficiency.
Major surgery or significant trauma within 28 days before first study drug, or anticipated need for major surgery before end of treatment. Start treatment only after complete wound healing.
Prior allogeneic stem-cell or solid organ transplant.
Severe hypersensitivity to chimeric or humanized antibodies or fusion proteins.
Known hypersensitivity to Chinese hamster ovary (CHO)–derived products or any component of the atezolizumab formulation.
Known hypersensitivity or allergy to pembrolizumab.
Known hypersensitivity or allergy to any component of the RO7502175 formulation.
The Estimated Number of Participants
-
Taiwan
18 participants
-
Global
224 participants
