ClinicaliQ Trial Snapshot
- AZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2 — Recruiting • Phase II • Oncology • NCT06219941.
- What is being tested: AZD0901, a novel therapeutic agent, is being evaluated as both monotherapy and in combination with existing anti-cancer agents in patients with advanced solid tumours that express the Claudin18.2 (CLDN18.2) biomarker, with assessment of safety, tolerability, efficacy, pharmacokinetics, and….
- Patient eligibility overview: The trial includes adults with locally advanced unresectable or metastatic solid tumours that demonstrate CLDN18.2 expression, representing patients with limited treatment options who may benefit from this biomarker-directed approach.
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- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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 .
Eligibility Snapshot
- 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. * Body weight > 35 kg. * Participants are willing to comply with contraception requirements. Sub study 1 Specific Inclusion criteria: * Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction. * Advanced or metastatic GC/GEJC. * Maximum 2 prior lines of systemic treatment for unresectable or metastatic disease. Sub study 2 Specific Inclusion criteria: * Participants diagnosed with histologically confirmed metastatic or advanced PDAC. * Availability of an archival sample or a fresh tumour biopsy taken at screening. * No prior treatments for unresectable or metastatic disease. Prior neoadjuvant/adjuvant chemotherapy is permitted as…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.