Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Santa Monica, California and other locations
Dates
study started
completion around
Principal Investigator
by Zev A. Wainberg, MD
Headshot of Zev A. Wainberg
Zev A. Wainberg

Description

Summary

The primary purpose of this study is to assess the safety and tolerability of AB598 when taken alone, and in combination with zimberelimab and standard chemotherapy in participants with advanced malignancies.

Official Title

A Phase 1/1b Study to Evaluate the Safety and Tolerability of AB598 Monotherapy and Combination Therapy in Participants With Advanced Malignancies

Keywords

Advanced Cancer, Advanced Malignancies, Bladder Cancer, Cervical Cancer, Esophageal Cancer, Gastric Cancer, Gastroesophageal-junction Cancer (GEJ), Head and Neck Squamous Cell Carcinoma (HNSCC), Non-Small Cell Lung Cancer (NSCLC), Ovarian Cancer, Renal Cell Carcinoma (RCC), Triple Negative Breast Cancer (TNBC), AB598, AB122, Zimberelimab, Carcinoma, Neoplasms, Renal Cell Carcinoma, Triple Negative Breast Neoplasms, Squamous Cell Carcinoma of Head and Neck, Leucovorin, Oxaliplatin, Fluorouracil

Eligibility

You can join if…

Open to people ages 18 years and up

  • Must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) guidance
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
  • Monotherapy-specific criteria for dose escalation cohorts:
    • Dose Escalation: Participants may have any pathologically confirmed advanced or metastatic solid tumor malignancy for which standard therapy has proven ineffective, intolerable, or is considered inappropriate.
    • Pharmacodynamic Cohorts: Participants may have any pathologically confirmed advanced or metastatic solid tumors for which standard therapy has proven ineffective, intolerable, or is considered inappropriate. Participants must be able to undergo collection of a fresh frozen biopsy during screening, as well as provide an on-treatment fresh frozen biopsy.
  • Dose Expansion cohort criteria
    • Histologically confirmed, documented diagnosis of HER2-negative locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma.
    • No prior systemic treatment for locally advanced unresectable or metastatic disease.
    • Cannot have progressed within 6 months of prior platinum-based chemotherapy for earlier stage disease.
    • Prior systemic radiation or whole brain radiation therapy must have been completed at least 4 weeks before investigational product (IP) administration.

You CAN'T join if...

  • Use of any live vaccines against infectious diseases (eg, influenza, varicella) within 4 weeks (28 days) of initiation of study
  • Underlying medical conditions or AEs that, in the investigator or sponsor's opinion, will make the administration of the study drugs hazardous
  • Any active or documented history of autoimmune disease including but not limited to inflammatory bowel disease, celiac disease, Wegner syndrome, Hashimoto syndrome, systemic lupus erythematosus, scleroderma, sarcoidosis, or autoimmune hepatitis, within 3 years of the first dose of study treatment
  • History of trauma or major surgery within 28 days prior to the first dose of study drug
  • Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressant medication during study treatment with certain protocol specified exceptions

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

Locations

  • Ronald Reagan UCLA Medical Center accepting new patients
    Santa Monica California 90095 United States
  • Mayo Clinic Arizona accepting new patients
    Phoenix Arizona 85054 United States

Lead Scientist at UCLA

  • Zev A. Wainberg, MD
    Zev Wainberg, M.D., holds the Estelle, Abe, and Marjorie Sanders Chair in Cancer Research.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Arcus Biosciences, Inc.
Links
ARC-25 - Public website Sign up for this study
ID
NCT05891171
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 87 study participants
Last Updated