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A Study to Evaluate AB308 in Combination With AB122 in Participants With Advanced Malignancies

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Brief Summary

This is a Phase 1/1b, multicenter, open-label, dose-escalation, and dose-expansion study to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and clinical activity of AB308 in combination with zimberelimab (AB122) in participants with advanced malignancies.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase I

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

Inclusion Criteria:

  • Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
  • Male or female participants ≥ 18 years of age (or age ≥ regionally approved age of consent for participation in investigational clinical studies) at the time of signing the informed consent.
  • Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
  • Adequate organ and marrow function

Exclusion Criteria:

  • History of trauma or major surgery within 28 days prior to the first dose of study treatment.
  • Prior treatment with an anti-TIGIT antibody.
  • Any active or prior autoimmune disease that required treatment within 3 years of the first dose of study treatment.
  • Prior chemotherapy, targeted small-molecule therapy, immunotherapy, or biologic agents, or use of other investigational drugs within 28 days before first dose of study treatment.
  • Discontinued prior immunotherapy for immune related adverse events with a high severity.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

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Study Stats
Protocol No.
21-001159
Category
Hematology-Oncology
Oncology
Contact
Lisa Yonemoto
Location
  • UCLA Santa Monica
  • UCLA Westwood
For Providers
NCT No.
NCT04772989
For detailed technical eligibility, visit ClinicalTrials.gov.