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)
AstraZeneca
Summary
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.
Description
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 diffe…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
The list below is a summarised eligibility criteria for the study - refer to the study protocol for full criteria. Master Inclusion Criteria applicable to all sub studies: * Participant must be ≥ 18 years or the legal age of consent at the time of signing the ICF. * Participants who are CLDN18.2 positive. * Must have at least one measurable lesion according to RECIST v1.1. * ECOG performance status of 0 to 1 with no deterioration over the previous 2 weeks prior first day of dosing. * Predicted life expectancy of ≥ 12 weeks. * Adequate organ and bone marrow function as defined by protocol. *…
Interventions
- DrugAZD0901
Antibody-drug conjugate/Biologic
- Drug5-Fluorouracil
Chemotherapy agents
- DrugLeucovorin
Chemotherapy agents
- Drugl-leucovorin
Chemotherapy agents
- DrugIrinotecan
Chemotherapy agents
- DrugNanoliposomal Irinotecan
Chemotherapy agents
- DrugGemcitabine
Chemotherapy agents
Locations (52)
- Research SiteOrange, California
- Research SitePalo Alto, California
- Research SiteSanta Rosa, California
- Research SiteLouisville, Kentucky
- Research SiteCommack, New York
- Research SiteProvidence, Rhode Island