Study identifier:D9800C00001
ClinicalTrials.gov identifier:NCT06219941
EudraCT identifier:N/A
CTIS identifier:2023-508275-37-00
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 (CLARITY-PanTumour01)
gastric cancer
Phase 2
No
AZD0901, 5-Fluorouracil, Leucovorin, l-leucovorin, Irinotecan, Nanoliposomal Irinotecan, Gemcitabine
All
190
Interventional
18 Years - n/a
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Apr 2025 by AstraZeneca
AstraZeneca
-
The purpose of this study is to assess the safety, tolerability, efficacy, pharmacokinetics (PK), and immunogenicity of AZD0901 as monotherapy and in combination with anti-cancer agents in participants with locally advanced unresectable or metastatic solid tumours expressing CLDN18.2.
This open-label, multi-centre study consists of individual sub studies, each evaluating the safety and tolerability of AZD0901. Sub study 1 will investigate the safety, tolerability, and anti-tumour activity of AZD0901 monotherapy in participants with advanced or metastatic gastric esophageal cancer expressing CLDN18.2. Participants will receive AZD0901 monotherapy via intravenous (IV) infusion and will be randomised in to one of 2 arms. Sub study 2 will consist of two parts, a safety run-in and a dose expansion part to investigate the safety and efficacy of AZD0901 in combination with different chemotherapy agents in participants with pancreatic cancer. Substudy 3 will investigate the safety, tolerability, and anti-tumour activity of AZD0901 monotherapy in participants with advanced or metastatic Biliary tract cancer.
Location
Status
Location
Taichung, Taiwan, Province of China, 404
Status
Recruiting
Location
Taoyuan, Taiwan, Province of China, 00333
Status
Recruiting
Location
Tainan City, Taiwan, Province of China, 70403
Status
Recruiting
Location
Kaohsiung, Taiwan, Province of China, 80756
Status
Recruiting
Location
Providence, RI, United States, 02903
Status
Recruiting
Location
Kuala Lumpur, Malaysia, 59100
Status
Recruiting
Location
Bukit Merah, Singapore, 169610
Status
Recruiting
Location
Singapore, Singapore, 119074
Status
Recruiting
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 IN PANCREATIC DUCTAL ADENOCARCINOMA 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 |
Experimental: Sub Study 3: AZD0901 MONOTHERAPY IN BILIARY TRACT CANCER Substudy 3 Further evaluate the preliminary anti-tumour activity of AZD0901 monotherapy by assessment of DRR. | Drug: AZD0901 Antibody-drug conjugate/Biologic Other Name: CMG901 |
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