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Brief Title: AB598 Monotherapy and Combination Therapy in Participants With Advanced Cancers

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

INTRODUCTION

  • Org Study ID: ARC-25
  • Secondary ID: N/A
  • NCT ID: NCT05891171
  • Sponsor: Arcus Biosciences, Inc.

BRIEF 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.

  • Overall Status
    Recruiting
  • Start Date
    October 13, 2023
  • Phase
    Phase 1
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A

CONDITION

  • 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)

ELIGIBILITY

Key Inclusion Criteria:
* 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:
* Participants may have any pathologically confirmed advanced or metastatic solid tumor malignancy for which standard therapy has proven ineffective, intolerable, or considered inappropriate

- * Disease-specific criteria for dose-expansion Cohort 1 (NSCLC):
* Histologically confirmed, documented diagnosis of locally advanced unresectable or metastatic non-squamous NSCLC

- * Treatment-naive in the unresectable locally advanced or metastatic setting

- * Cannot have progressed within 6 months of prior platinum-based chemotherapy for earlier stage disease

- * Mixed small-cell lung cancer histology is not permitted

- * Disease-specific criteria for dose expansion Cohort 2 (Gastric/GEJ):
* Histologically confirmed, documented diagnosis of human epidermal growth factor 2 (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
Key Exclusion Criteria:
* 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's 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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Medical Director

Role: Study Director

Affiliation: Arcus Biosciences

Overall Contact

Name: Medical Director

Phone: +1-510-462-3330

Email: ClinicalTrials@arcusbio.com

LOCATION

Facility Status Contact
Facility: Lake City Cancer Care, LLC.
Lake City, Florida 32024
United States
Status: Recruiting Contact: N/A
Facility: Affinity Health-Hope and Healing Cancer Services, LLC
Hinsdale, Illinois 60521
United States
Status: Recruiting Contact: N/A
Facility: Goshen Center for Cancer Care
Goshen, Indiana 46526
United States
Status: Recruiting Contact: N/A
Facility: Karmanos Cancer Institute
Detroit, Michigan 48201
United States
Status: Recruiting Contact: N/A
Facility: Gabrail Cancer Center
Canton, Ohio 44718
United States
Status: Recruiting Contact: N/A
Facility: Next Oncology Dallas
Dallas, Texas 75039
United States
Status: Recruiting Contact: N/A
Facility: Next Oncology Virginia
Fairfax, Virginia 22031
United States
Status: Recruiting Contact: N/A