Clinical Trials List
Protocol NumberGO44096
NCT Number(ClinicalTrials.gov Identfier)NCT05661578
Active
2023-03-08 - 2025-12-31
Phase II
Not yet recruiting4
A Phase II, Single-Arm, Open-Label Study Evaluating the Safety and Pharmacokinetics of the Intravenous Fixed-Dose Combination (IV FDC) of Tiragolumab and Atezolizumab in Participants With Locally Advanced, Recurrent or Metastatic Solid Tumors
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- Hung-Wei Wang Digestive System Department
- Chih-Yen Tu Division of Thoracic Medicine
- Hsueh-Chou Lai Digestive System Department
- Che-Hung Lin Division of Hematology & Oncology
- 陳鴻仁 Division of Thoracic Medicine
- Li-Yuan Bai Division of Hematology & Oncology
- Ming-Yu Lien Division of Hematology & Oncology
- Ching Yun Hsieh Division of Hematology & Oncology
- Chen-Yuan Lin Division of Hematology & Oncology
- Su-Peng Yeh Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- Tien-Hua Chen Division of Hematology & Oncology
- Mu-Hsin Chang Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- 莊建淮 Division of Hematology & Oncology
- Kun-Huei Yeh Division of Hematology & Oncology
- Chia-Chi Lin Division of Hematology & Oncology
- TA-CHEN HUANG Division of Hematology & Oncology
- FU-JEN HSUEH Division of Hematology & Oncology
- JHE-CYUAN GUO Division of Hematology & Oncology
- Yu-Chieh Tsai Division of Hematology & Oncology
- Hsiang-Fong Kao Division of Hematology & Oncology
- HUAI-CHENG HUANG Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- 劉奕廷 Division of Hematology & Oncology
- Chien-Jui Huang Division of General Internal Medicine
- 顏志傑 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Condition/Disease
PD-L1-selected Solid Tumors
Objectives
The purpose of this trial is to test the safety, tolerability and effects (good or bad) of an experimental drug called tiragolumab in combination with a drug called atezolizumab in people with locally advanced or metastatic (spread to other parts of the body) cancer. ) and learn how the body processes both drugs.
Test Drug
T+A IV FDC (RO7538483)
Active Ingredient
atezolizumab
tiragolumab
tiragolumab
Dosage Form
solution
Dosage
80 mg/mL
40 mg/mL
40 mg/mL
Endpoints
Evaluating the safety and tolerability of Tiragolumab versus Atezolizumab IV FDC
Inclution Criteria
Inclusion Criteria:
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Life expectancy >=12 weeks
Adequate hematologic and end organ function
Recovery (i.e., improvement to Grade 1 or better) from all acute toxicities from previous therapy, excluding alopecia
For female participants of childbearing potential, negative serum pregnancy test within 14 days prior to initiation of study treatment (Day 1 of Cycle 1)
For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agree to refrain from donating eggs during the treatment period and for 5 months after the final dose of tiragolumab and atezolizumab IV FDC
For male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agree to refrain from donating sperm during the treatment period and for 90 days after the final dose of tiragolumab and atezolizumab IV FDC to avoid exposing the embryo
Cancer-Specific Inclusion Criteria:
Histologic documentation of locally advanced, recurrent, or metastatic malignancy, ineligible for definitive local therapy, for which a clinical trial of an investigational agent in combination with an anti-PD-L1 antibody is considered an acceptable treatment option. Participant must be informed of all standard of care options available for his/her cancer.
No prior treatment with checkpoint inhibitor therapies (CPI-Naive)
Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Submittal of archival tumor and/or fresh tumor tissue to the central laboratory for programmed death-1 (PD-L1) evaluation prior to enrollment
PD-L1 selected tumors, as determined by the investigational VENTANA PD-L1 (SP263) immunohistochemistry (IHC) assay
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Life expectancy >=12 weeks
Adequate hematologic and end organ function
Recovery (i.e., improvement to Grade 1 or better) from all acute toxicities from previous therapy, excluding alopecia
For female participants of childbearing potential, negative serum pregnancy test within 14 days prior to initiation of study treatment (Day 1 of Cycle 1)
For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agree to refrain from donating eggs during the treatment period and for 5 months after the final dose of tiragolumab and atezolizumab IV FDC
For male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agree to refrain from donating sperm during the treatment period and for 90 days after the final dose of tiragolumab and atezolizumab IV FDC to avoid exposing the embryo
Cancer-Specific Inclusion Criteria:
Histologic documentation of locally advanced, recurrent, or metastatic malignancy, ineligible for definitive local therapy, for which a clinical trial of an investigational agent in combination with an anti-PD-L1 antibody is considered an acceptable treatment option. Participant must be informed of all standard of care options available for his/her cancer.
No prior treatment with checkpoint inhibitor therapies (CPI-Naive)
Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Submittal of archival tumor and/or fresh tumor tissue to the central laboratory for programmed death-1 (PD-L1) evaluation prior to enrollment
PD-L1 selected tumors, as determined by the investigational VENTANA PD-L1 (SP263) immunohistochemistry (IHC) assay
Exclusion Criteria
Exclusion Criteria:
Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 5 months after the final dose of tiragolumab and atezolizumab IV FDC
Significant cardiovascular disease
Known clinically significant liver disease
Poorly controlled Type 2 diabetes mellitus
Major surgical procedure within 28 days prior to Day 1 of Cycle 1 or anticipation of need for a major surgical procedure during the study
Any other diseases, metabolic dysfunction, physical examination finding, and/or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or may render the participant at high risk from treatment complications
History of autoimmune disease
Treatment with systemic immunosuppressive medications within 2 weeks prior to Day 1 of Cycle 1
History of idiopathic pulmonary fibrosis, pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
Severe infections within 4 weeks prior to Day 1 of Cycle 1 or recent infections/oral or IV antibiotics within 2 weeks prior to Day 1 of Cycle 1
Cancer-Specific Exclusion Criteria:
Any anti-cancer therapy, whether investigational or approved within 3 weeks prior to initiation of study treatment
Prior treatment with immune checkpoint inhibitors (CPIs)
Less than 5 drug-elimination half-lives (~100 days for typical monoclonal antibody [Mab]) from the last dose of monoclonal antibodies (MAbs), and MAb-Derived Therapies (excluding CPIs) and the proposed Day 1 of Cycle 1
Less than 6 weeks between the last dose of prior immunomodulators and the proposed Day 1 of Cycle 1
Less than 6 weeks or 5-drug-elimination half-lives, whichever is shorter, of prior treatment with cancer vaccines and/or cytokines have elapsed between the last dose and the proposed Cycle 1, Day 1
Any history of an immune-mediated Grade 4 adverse event attributed to prior cancer immunotherapy
Any history of an immune-mediated Grade 3 adverse event attributed to prior cancer immunotherapy that resulted in permanent discontinuation of the prior immunotherapeutic agent and/or occurred Any immune-mediated adverse events related to prior cancer immunotherapy must have resolved completely to baseline
Adverse events from prior anti-cancer therapy that have not resolved to Grade <=1 except for alopecia, vitiligo, or endocrinopathy managed with replacement therapy
Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 5 months after the final dose of tiragolumab and atezolizumab IV FDC
Significant cardiovascular disease
Known clinically significant liver disease
Poorly controlled Type 2 diabetes mellitus
Major surgical procedure within 28 days prior to Day 1 of Cycle 1 or anticipation of need for a major surgical procedure during the study
Any other diseases, metabolic dysfunction, physical examination finding, and/or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or may render the participant at high risk from treatment complications
History of autoimmune disease
Treatment with systemic immunosuppressive medications within 2 weeks prior to Day 1 of Cycle 1
History of idiopathic pulmonary fibrosis, pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
Severe infections within 4 weeks prior to Day 1 of Cycle 1 or recent infections/oral or IV antibiotics within 2 weeks prior to Day 1 of Cycle 1
Cancer-Specific Exclusion Criteria:
Any anti-cancer therapy, whether investigational or approved within 3 weeks prior to initiation of study treatment
Prior treatment with immune checkpoint inhibitors (CPIs)
Less than 5 drug-elimination half-lives (~100 days for typical monoclonal antibody [Mab]) from the last dose of monoclonal antibodies (MAbs), and MAb-Derived Therapies (excluding CPIs) and the proposed Day 1 of Cycle 1
Less than 6 weeks between the last dose of prior immunomodulators and the proposed Day 1 of Cycle 1
Less than 6 weeks or 5-drug-elimination half-lives, whichever is shorter, of prior treatment with cancer vaccines and/or cytokines have elapsed between the last dose and the proposed Cycle 1, Day 1
Any history of an immune-mediated Grade 4 adverse event attributed to prior cancer immunotherapy
Any history of an immune-mediated Grade 3 adverse event attributed to prior cancer immunotherapy that resulted in permanent discontinuation of the prior immunotherapeutic agent and/or occurred Any immune-mediated adverse events related to prior cancer immunotherapy must have resolved completely to baseline
Adverse events from prior anti-cancer therapy that have not resolved to Grade <=1 except for alopecia, vitiligo, or endocrinopathy managed with replacement therapy
The Estimated Number of Participants
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Taiwan
8 participants
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Global
60 participants
