Clinical Trials List
Protocol NumberD7040C00001
NCT Number(ClinicalTrials.gov Identfier)NCT06795022
Active
2025-05-01 - 2028-12-31
Phase I/II
Recruiting2
A Modular Phase I/II Open-label Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD9793, a T Cell-engaging Antibody Targeting Glypican-3 (GPC3) in Adult Participants With Advanced or Metastatic Solid Tumours (RHEA-1)
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Trial Applicant
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Sponsor
AstraZeneca
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- 莊建淮 無
- TSUNG-HAO LIU 無
- Ann-Lii Cheng Division of Hematology & Oncology
- 陳柏邑 Division of Hematology & Oncology
- Chih-Hung Hsu Division of Hematology & Oncology
- 呂理駿 Division of Hematology & Oncology
- Ying-Chun Shen Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Chia-Hsun Hsieh
Co-Principal Investigator
- Shi-Ming Lin Digestive System Department
- 滕威 無
- Ming-Mo Hou 無
- Cheng-Lung Hsu 無
- Wen-Chi Chou 無
- Yung-Chia Kao 無
- Jen-Shi Chen 無
- Hung-Ming Wang 無
- Chen-Chun Lin Digestive System Department
- 呂嘉偉 Digestive System Department
- Hung-Chih Hsu 無
- Yung-Chang Lin 無
- 王瑜肇 無
- Chun-Yen Lin Digestive System Department
- 周宏學 Division of Gastroenterological Surgery
- Kun-Ming Chan 無
- 湯文誠 無
- 林伯庭 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
(1)To investigate the safety and tolerability of AZD9793 monotherapy in participants with advanced or metastatic solid tumors expressing Glypican 3 (GPC3), and to determine the Maximum Tolerated Dose (MTD), Optimal Biological Dose (OBD), and/or Recommended Dose for Expansion (RDE), and the Recommended Phase 2 Dose (RP2D).(2)To evaluate the preliminary anti-tumor activity of AZD9793 monotherapy in participants with advanced or metastatic solid tumors expressing GPC3.
Objectives
This research is designed to determine if experimental treatment with AZD9793, a T cell-engaging antibody that targets GPC3, is safe, tolerable and has anti-cancer activity in patients with advanced or metastatic solid tumours which are GPC3+.
Test Drug
AZD9793
Active Ingredient
AZD9793
Dosage Form
Lyophilized Dry Powder for Injection
Dosage
20 mg/mL
Endpoints
(1)To investigate the safety and tolerability of AZD9793 monotherapy in participants with advanced or metastatic solid tumors expressing Glypican 3 (GPC3), and to determine the Maximum Tolerated Dose (MTD), Optimal Biological Dose (OBD), and/or Recommended Dose for Expansion (RDE), and the Recommended Phase 2 Dose (RP2D).
(2)To evaluate the preliminary anti-tumor activity of AZD9793 monotherapy in participants with advanced or metastatic solid tumors expressing GPC3.
(2)To evaluate the preliminary anti-tumor activity of AZD9793 monotherapy in participants with advanced or metastatic solid tumors expressing GPC3.
Inclution Criteria
Key Inclusion Criteria:
-Age ≥ 18 at the time of signing the informed consent.
-GPC3 positive tumour as determined by a central laboratory using an analytically validated IHC assay.
-Must have at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
-Eastern Cooperative Oncology Group Performance status (ECOG PS): 0-1 at screening.
-Predicted life expectancy of ≥ 12 weeks.
-Adequate organ and bone marrow function measured within 28 days prior to first dose as defined by the protocol.
-Contraceptive use by men or women should be consistent with local regulations, as defined by the protocol.
-Confirmed advanced recurrent and/or metastatic and/or unresectable HCC, which is histopathologically proven based on the criteria established by the World Health Organization.
-Barcelona Clinic Liver Cancer (BCLC) stage B (that is not eligible for locoregional therapy) or stage C.
-Child-Pugh Score class A.
-Previous therapy:
-Age ≥ 18 at the time of signing the informed consent.
-GPC3 positive tumour as determined by a central laboratory using an analytically validated IHC assay.
-Must have at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
-Eastern Cooperative Oncology Group Performance status (ECOG PS): 0-1 at screening.
-Predicted life expectancy of ≥ 12 weeks.
-Adequate organ and bone marrow function measured within 28 days prior to first dose as defined by the protocol.
-Contraceptive use by men or women should be consistent with local regulations, as defined by the protocol.
-Confirmed advanced recurrent and/or metastatic and/or unresectable HCC, which is histopathologically proven based on the criteria established by the World Health Organization.
-Barcelona Clinic Liver Cancer (BCLC) stage B (that is not eligible for locoregional therapy) or stage C.
-Child-Pugh Score class A.
-Previous therapy:
Exclusion Criteria
Key Exclusion Criteria:
-Unresolved toxicity from prior anticancer therapy, including imAEs, of Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥ 2 except for vitiligo, peripheral neuropathy related to prior anti-cancer therapy, alopecia, endocrine disorders that are controlled with replacement hormone therapy and asymptomatic laboratory abnormalities.
-Prior to enrolment, participation in another clinical study with an investigational product administered in the last 21 days or 5 half-lives whichever is shorter.
-CAR-T cell therapy within the last 6 months prior to enrolment on this study.
-Known allergy or hypersensitivity to AZD9793 or any of the excipients of the product as outlined in the IB.
-Requires chronic immunosuppressive therapy (including steroids > 10 mg prednisone/day or equivalent).
-Prior treatment with any therapy that is targeted to GPC3.
-Received radiation within 14 days prior to first dose of study treatment; palliative radiation to reduce the risk of tumour lysis syndrome (TLS) or CRS/neurotoxicity in participants with bulky disease is permitted.
-Undergone a major surgical procedure within 14 days prior to first dose of study treatment days to allow adequate healing
-Experienced unacceptable cytokine release syndrome (CRS) or Immune Effector Cell Associated Neurotoxicity (ICANS) following prior T cell engagers (TCE) or chimeric antigen receptor T (CAR-T) cell therapy.
-Previous history of hemophagocytic lymphohistiocytosis (HLH) / macrophage activation syndrome (MAS).
-Active or prior documented autoimmune or inflammatory disorders within 3 years of start of treatment.
-Cardiac conditions as defined by the protocol.
-History of thromboembolic event within the past 3 months prior to the scheduled first dose of study intervention.
-Central nervous system (CNS) metastases or CNS pathology, as defined by the protocol, within 3 months prior to consent.
Infectious disease including active human immunodeficiency virus (HIV), and uncontrolled active systemic fungal, bacterial or other infection.
-Known fibrolamellar HCC, sarcomatoid HCC, or combined hepatocellular malignant cholangiocarcinoma.
-Unresolved toxicity from prior anticancer therapy, including imAEs, of Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥ 2 except for vitiligo, peripheral neuropathy related to prior anti-cancer therapy, alopecia, endocrine disorders that are controlled with replacement hormone therapy and asymptomatic laboratory abnormalities.
-Prior to enrolment, participation in another clinical study with an investigational product administered in the last 21 days or 5 half-lives whichever is shorter.
-CAR-T cell therapy within the last 6 months prior to enrolment on this study.
-Known allergy or hypersensitivity to AZD9793 or any of the excipients of the product as outlined in the IB.
-Requires chronic immunosuppressive therapy (including steroids > 10 mg prednisone/day or equivalent).
-Prior treatment with any therapy that is targeted to GPC3.
-Received radiation within 14 days prior to first dose of study treatment; palliative radiation to reduce the risk of tumour lysis syndrome (TLS) or CRS/neurotoxicity in participants with bulky disease is permitted.
-Undergone a major surgical procedure within 14 days prior to first dose of study treatment days to allow adequate healing
-Experienced unacceptable cytokine release syndrome (CRS) or Immune Effector Cell Associated Neurotoxicity (ICANS) following prior T cell engagers (TCE) or chimeric antigen receptor T (CAR-T) cell therapy.
-Previous history of hemophagocytic lymphohistiocytosis (HLH) / macrophage activation syndrome (MAS).
-Active or prior documented autoimmune or inflammatory disorders within 3 years of start of treatment.
-Cardiac conditions as defined by the protocol.
-History of thromboembolic event within the past 3 months prior to the scheduled first dose of study intervention.
-Central nervous system (CNS) metastases or CNS pathology, as defined by the protocol, within 3 months prior to consent.
Infectious disease including active human immunodeficiency virus (HIV), and uncontrolled active systemic fungal, bacterial or other infection.
-Known fibrolamellar HCC, sarcomatoid HCC, or combined hepatocellular malignant cholangiocarcinoma.
The Estimated Number of Participants
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Taiwan
15 participants
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Global
304 participants
