Esophageal Cancer Clinical Trial

Study of AB598 Monotherapy and Combination Therapy in Participants With Advanced Cancers

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.

View Eligibility Criteria

Eligibility Criteria

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.

Study is for people with:

Esophageal Cancer

Phase:

Phase 1

Estimated Enrollment:

81

Study ID:

NCT05891171

Recruitment Status:

Recruiting

Sponsor:

Arcus Biosciences, Inc.

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There are 9 Locations for this study

See Locations Near You

Lake City Cancer Care, LLC.
Lake City Florida, 32024, United States
Affinity Health-Hope and Healing Cancer Services, LLC
Hinsdale Illinois, 60521, United States
Goshen Center for Cancer Care
Goshen Indiana, 46526, United States
Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Rutgers Cancer Institute of New Jersey
New Brunswick New Jersey, 08901, United States
Gabrail Cancer Center
Canton Ohio, 44718, United States
University Hospitals Cleveland Medical Center
Cleveland Ohio, 44106, United States
Next Oncology Dallas
Dallas Texas, 75039, United States
Next Oncology Virginia
Fairfax Virginia, 22031, United States

How clear is this clinincal trial information?

Study is for people with:

Esophageal Cancer

Phase:

Phase 1

Estimated Enrollment:

81

Study ID:

NCT05891171

Recruitment Status:

Recruiting

Sponsor:


Arcus Biosciences, Inc.

How clear is this clinincal trial information?

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