Study of AB598 Monotherapy and Combination Therapy in Participants With Advanced Cancers (ARC-25)

Arcus Biosciences

Status and phase

Enrolling

Phase 1

Conditions

Advanced Malignancies

Triple Negative Breast Cancer (TNBC)

Esophageal Cancer

Non-Small Cell Lung Cancer (NSCLC)

Gastroesophageal-junction Cancer (GEJ)

Ovarian Cancer

Advanced Cancer

Bladder Cancer

Renal Cell Carcinoma (RCC)

Gastric Cancer

Head and Neck Squamous Cell Carcinoma (HNSCC)

Cervical Cancer

Treatments

Drug: Zimberelimab

Drug: Leucovorin

Drug: Oxaliplatin

Drug: Fluorouracil

Drug: AB598

Study type

Interventional

Funder types

Industry

Identifiers

NCT05891171

ARC-25

Details and patient eligibility

About

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.

Enrollment

87 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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:
- 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.

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 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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

87 participants in 8 patient groups

Dose Escalation Cohort 1

Experimental group

Description:

Participants will receive AB598 intravenous (IV) infusion once every 3 weeks

Treatment:

Drug: AB598

Dose Escalation Cohort 2

Experimental group

Description: