Study identifier:D9800C00001
ClinicalTrials.gov identifier:NCT06219941
EudraCT identifier:N/A
CTIS identifier:N/A
A Phase II, Open-label, Multi-centre Study to Evaluate Safety, Tolerability, Efficacy, PK, and Immunogenicity of AZD0901 as Monotherapy and in Combination with Anti-cancer Agents in Participants with Advanced Solid Tumours Expressing Claudin 18.2.
gastric cancer
Phase 2
No
AZD0901, 5-Fluorouracil, Leucovorin, l-leucovorin, Irinotecan, Nanoliposomal Irinotecan, Gemcitabine
All
123
Interventional
18 Years - n/a
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Oct 2024 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Sub Study 1 - AZD0901 MONOTHERAPY Sub Study 1 will investigate AZD0901 monotherapy in order to evaluate the safety, tolerability, and efficacy of AZD0901. | Drug: AZD0901 Antibody-drug conjugate/Biologic Other Name: CMG901 |
Experimental: Sub Study 2 - AZD0901 IN COMBINATION WITH ANTI-CANCER AGENTS Substudy 2 will investigate the safety and efficacy of AZD0901 as first line systemic treatment used in combination with different chemotherapy agents | Drug: AZD0901 Antibody-drug conjugate/Biologic Other Name: CMG901 Drug: 5-Fluorouracil Chemotherapy agents Other Name: 5-FU Drug: Leucovorin Chemotherapy agents Other Name: LV Drug: l-leucovorin Chemotherapy agents Other Name: I-LV Drug: Irinotecan Chemotherapy agents Other Name: Camptosar Drug: Nanoliposomal Irinotecan Chemotherapy agents Other Name: ONIVYDE Drug: Gemcitabine Chemotherapy agents Other Name: Gemzar |