JPRN-jRCT2031230200
Recruiting
Phase 1
Phase I/II Study of AZD5863 in Adult Participants with Advanced or Metastatic Solid Tumors
Hibi Kazushige0 sites200 target enrollmentJuly 1, 2023
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Gastric cancerGastro-esophageal junction cancerPancreatic ductal adenocarcinomaEsophageal aden
- Sponsor
- Hibi Kazushige
- Enrollment
- 200
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •\- 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
Outcomes
Primary Outcomes
Not specified
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