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

Sponsor

Arcus Biosciences, Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05891171

Collaborator

(none)

Enrollment

Arms

28.1

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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)	Drug: AB598 Drug: Zimberelimab Drug: Carboplatin Drug: Pemetrexed Drug: Fluorouracil Drug: Leucovorin Drug: Oxaliplatin	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

81 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jun 30, 2023

Anticipated Primary Completion Date :

Nov 1, 2025

Anticipated Study Completion Date :

Nov 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dose Escalation Cohort 1 Participants will receive AB598 intravenous (IV) infusion once every 3 weeks	Drug: AB598 Administered as specified in the treatment arm
Experimental: Dose Escalation Cohort 2 Participants will receive AB598 IV infusion once every 3 weeks	Drug: AB598 Administered as specified in the treatment arm
Experimental: Dose Escalation Cohort 3 Participants will receive AB598 IV infusion once every 3 weeks	Drug: AB598 Administered as specified in the treatment arm
Experimental: Dose Escalation Cohort 4 Participants will receive AB598 IV infusion once every 3 weeks	Drug: AB598 Administered as specified in the treatment arm
Experimental: Dose Expansion Cohort 1 NSCLC Participants will receive AB598 IV infusion in combination with zimberelimab and carboplatin/pemetrexed once every 3 weeks, for up to 2 years	Drug: AB598 Administered as specified in the treatment arm Drug: Zimberelimab Administered as specified in the treatment arm Other Names: AB122 Drug: Carboplatin Administered as specified in the treatment arm Drug: Pemetrexed Administered as specified in the treatment arm
Experimental: Dose Expansion Cohort 2 Gastric/GEJ Cancer Participants will receive AB598 IV infusion in combination with zimberelimab once every 3 weeks, and FOLFOX (oxaliplatin, leucovorin, fluorouracil) every 2 weeks, for up to 2 years	Drug: AB598 Administered as specified in the treatment arm Drug: Zimberelimab Administered as specified in the treatment arm Other Names: AB122 Drug: Fluorouracil Administered as specified in the treatment arm Drug: Leucovorin Administered as specified in the treatment arm Drug: Oxaliplatin Administered as specified in the treatment arm

Outcome Measures

Primary Outcome Measures

Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [Up to 2 years]
Dose Escalation Cohorts: Number of Participants with Dose-Limiting Toxicities (DLTs) [Up to 2 years]

Secondary Outcome Measures

Area Under the Concentration-Time Curve from Administration ("0") to the Time That the Drug is No Longer Present in the Body ("infinity") (AUC 0-inf) in Whole Blood and Plasma [Predose, Up to 4 hours postdose]
Maximum Concentration (Cmax) in Whole Blood and Plasma [Predose, Up to 4 hours postdose]
Time to Maximum Concentration (Tmax) in Whole Blood and Plasma [Predose, Up to 4 hours postdose]
Number of Participants Who Test Positive for Antidrug Antibodies (ADAs) to AB598 [Up to 2 years]
Objective Response Rate (ORR) [Up to 2 years]
Dose Expansion Cohorts: Duration of Response (DOR) [Up to 2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 pathologically confirmed NSCLC, gastric/GEJ, esophageal, HNSCC, bladder, RCC, TNBC, cervical, and ovarian cancers 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
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

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.