A Phase I/II Open-label Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD5863, a T cell-engaging Bispecific Antibody that Targets Claudin 18.2 (CLDN18.2) and CD3 in Adult Participants with Advanced or Metastatic Solid Tumors
- Conditions
- Gastric cancerGastro-esophageal junction cancerPancreatic ductal adenocarcinomaEsophageal aden
- Registration Number
- JPRN-jRCT2031230200
- Lead Sponsor
- Hibi Kazushige
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 200
Age 18 or more at the time of signing the informed consent
- Histologically confirmed diagnosis of adenocarcinoma of the stomach, gastro-esophageal junction, esophagus, or pancreas
- Must have at least one measurable lesion according to RECIST v1.1
- Must show positive CLDN18.2 expression in tumor cells as determined by central IHC
- Eastern Cooperative Oncology Group Performance status (ECOG PS): 0-1 at screening
- Predicted life expectancy of 12 weeks or more
- Adequate organ and bone marrow function measured within 28 days prior to first dose as defined by the protocol
- Contraceptive use by men or women should be consistent with local regulations, as defined by the protocol
- Must have received at least one prior line of systemic therapy in the advanced/metastatic setting
- Unresolved toxicity from prior anticancer therapy of Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or more except for those defined by the protocol
- Participant experienced unacceptable CRS or ICANS following prior TCE or CAR-T cell therapy
- Active or prior documented autoimmune or inflammatory disorders within 3 years of start of treatment
- CNS metastases or CNS pathology, as defined by the protocol, within 3 months prior to consent
- Infectious disease including active HIV, active hepatitis B/C, uncontrolled active systemic fungal, bacterial or
other infection
- Cardiac conditions as defined by the protocol
- History of thromboembolic event within the past 3 months prior to the scheduled first dose of study intervention
- Participant requires chronic immunosuppressive therapy
- Participants on anticoagulation therapy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - Incidence of Adverse Events (AEs), Adverse Event of Special Interest (AESIs), Dose-limiting Toxicities (DLTs <br><br>- dose escalation only) and Serious Adverse Events (SAEs)<br><br>- AEs leading to discontinuation of AZD5863<br><br>- Assess clinically significant alterations in vital signs and abnormal laboratory parameters<br><br>- Objective response rate (ORR) according to RECIST v1.1 (dose expansion only)
- Secondary Outcome Measures
Name Time Method