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

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

Primary Outcome 1 - Timeframe: Up to 2 years

Primary Outcome 2 - Measure: Dose Escalation Cohorts: Number of Participants with Dose-Limiting Toxicities (DLTs)

Primary Outcome 2 - Timeframe: Up to 2 years

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:
* 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.

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: [email protected]

LOCATION