Open Actively Recruiting

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

About

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
  • Performance status score of 0 or 1
  • Measurable disease as per radiographic evaluation
  • Disease-specific criteria for dose escalation:
    • Participants with any type of solid tumor for which no treatment is currently available, or
    • Participants with non-Hodgkin Lymphoma that has progressed on prior chemotherapy and have not or are unable to receive stem cell transplant. transfer
    • Participants may have received up to 5 prior anti-cancer therapies and an unlimited number of prior hormonal therapies.
  • Disease-specific criteria for dose-expansion Cohort 1:
    • Participants with previously untreated locally advanced or metastatic NSCLC with a high PD-L1 expression
  • Disease-specific criteria for dose-expansion Cohort 2:
    • Participants with metastatic melanoma with at least one prior anti-cancer therapy and progression after PD-L1 therapy
  • Disease-specific criteria for dose-expansion Cohort 3:
    • Participants with metastatic gastric, or gastroesophageal junction, or esophageal cancer with at least 1 prior chemotherapy and no prior PD-(L)1 therapy.
  • Disease-specific criteria for dose-expansion Cohort 4:
    • Participants with metastatic cervical cancer with at least 1 prior chemotherapy and no prior PD-(L)1 therapy.
  • Disease-specific criteria for dose-expansion Cohort 5
    • Participants with diffuse large B-cell lymphoma (DLBCL) with at least 2 prior anti-cancer therapies and have not or are unable to receive allogenic stem cell transplant
    • Participants with multiple myeloma with at least 3 prior anti-cancer therapies and for whom no treatment is currently available.

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.

Join this Trial

Contact our clinical trial navigators for opportunities that may be suitable for you
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.