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 Partisipants with Advanced Solid Tumours Expressing Claudin18.2. NOTE: Official Title should have no more than 240 characters.
- Conditions
- Gastric cancer, Gastroesophageal junction cancer
- Registration Number
- JPRN-jRCT2031230569
- Lead Sponsor
- Hibi Kazushige
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 186
Master Inclusion Criteria applicable to both sub sutudies:
- Participant must be 18 years or more 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 or more.
- Adequate organ and bone marrow function as defined by protocol.
- Body weight > 35kg.
- Participants are willing to comply with contraception requirements.
Sub study 1 Specific
- 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.
Master Exclusion Criteria applicable to both sub sutudies:
- Unstable or active peptic ulcer disease or digestive tract bleeding including but not limited to clinically significant bleeding on the setting of prior CLDN18.2 directed therapy.
- Participants with clinically significant ascites that require drainage.
- A history of drug-induced non-infectious ILD/pneumonitis.
- Central nervous system metastases or CNS pathology.
- Peripheral neuropathy Grade 2 or more at screening.
- History of another primary malignancy.
- Prior exposure to any MMAE-based ADC.
- Prior exposure to any CLDN18.2 targeted agents except anti-CLDN18.2 monoclonal antibody.
Sub Study 1 Specific
- Participants with HAR2-positive (3+ by IHC, or 2+ by IHC, and positive by ISH) or indeterminate GC/GEJC.
- Any factors that increase the risk of QTc prolongation or risk of arrhythmic events.
- The use of concomitant medications known to prolong the QT/QTc interval.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method