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
Status: Recruiting
Location: See all (25) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
This research is designed to determine if experimental treatment with AZD5863, a T cell-engaging bispecific antibody that targets Claudin 18.2 (CLDN18.2) and CD3, is safe, tolerable and has anti-cancer activity in patients with advanced solid tumors.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• Age ≥ 18 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 Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
• Must show positive CLDN18.2 expression in tumor cells as determined by central immunohistochemistry (IHC)
• Eastern Cooperative Oncology Group Performance status (ECOG PS): 0-1 at screening
• Predicted life expectancy of ≥ 12 weeks
• 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