Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

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.

Official Title

A Phase 1/1b Study to Evaluate the Safety and Tolerability of AB308 in Combination With AB122 in Participants With Advanced Malignancies

Keywords

Advanced Solid Tumor NSCLC Melanoma Cervical Cancer Multiple Myeloma Lymphoma, Non-Hodgkin DLBCL Gastric Cancer Gastroesophageal Junction Adenocarcinoma Esophageal Cancer Zimberelimab

Eligibility

For people ages 18 years and up

  • 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 unable to receive stem cell transplant or adoptive cell 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 unable to receive stem cell transplant or adoptive cell transfer, or
  • 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.

Locations

  • University of California, Los Angeles not yet accepting patients
    Los Angeles California 90095 United States
  • START South Texas Accelerated Research Therapeutics - Mountain Region accepting new patients
    West Valley City Utah 84119 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Arcus Biosciences, Inc.
ID
NCT04772989
Phase
Phase 1
Study Type
Interventional
Last Updated