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)
Conditions
Keywords
AB598, AB122, Zimberelimab
Brief summary
The primary purpose of this study is to assess the safety and tolerability of AB598 in participants with advanced malignancies.
Interventions
DRUGAB598
Administered as specified in the treatment arm
DRUGZimberelimab
Administered as specified in the treatment arm
DRUGFluorouracil
Administered as specified in the treatment arm
DRUGLeucovorin
Administered as specified in the treatment arm
DRUGOxaliplatin
Administered as specified in the treatment arm
Sponsors
Arcus Biosciences, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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 * Prior systemic radiation or whole brain radiation therapy must have been completed at least 4 weeks before investigational product (IP) administration. Other palliative radiotherapy must be completed 2 weeks before investigational product administration, if radiation therapy-related AEs have resolved to Grade ≤ 1. * Monotherapy-specific criteria for dose escalation and PD cohorts: * Dose Escalation: Participants may have any pathologically confirmed advanced or metastatic solid tumor 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. 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 post dose |
| Maximum Concentration (Cmax) in Whole Blood and Plasma | Predose, Up to 4 hours post dose |
| Time to Maximum Concentration (Tmax) in Whole Blood and Plasma | Predose, Up to 4 hours post dose |
| 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 Cohort: Duration of Response (DOR) | Up to 2 years |
Countries
Australia, Taiwan, United States
Contacts
STUDY_DIRECTORMedical Director
Arcus Biosciences
Outcome results
None listed