Ovarian Cancer Clinical Trial
— ARC-25Official title:
A Phase 1/1b Study to Evaluate the Safety and Tolerability of AB598 Monotherapy and Combination Therapy in Participants With Advanced Malignancies
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.
| Status | Recruiting |
| Enrollment | 81 |
| Est. completion date | August 2025 |
| Est. primary completion date | August 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| 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: - 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. |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Queen Elizabeth Hospital | Adelaide | |
| United States | Gabrail Cancer Center | Canton | Ohio |
| United States | University Hospitals Cleveland Medical Center | Cleveland | Ohio |
| United States | Next Oncology Dallas | Dallas | Texas |
| United States | Karmanos Cancer Institute | Detroit | Michigan |
| United States | Next Oncology Virginia | Fairfax | Virginia |
| United States | Goshen Center for Cancer Care | Goshen | Indiana |
| United States | Affinity Health-Hope and Healing Cancer Services, LLC | Hinsdale | Illinois |
| United States | Lake City Cancer Care, LLC. | Lake City | Florida |
| United States | Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey |
| Lead Sponsor | Collaborator |
|---|---|
| Arcus Biosciences, Inc. |
United States, Australia,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to 2 years | ||
| Primary | Dose Escalation Cohorts: Number of Participants with Dose-Limiting Toxicities (DLTs) | Up to 2 years | ||
| Secondary | 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 | ||
| Secondary | Maximum Concentration (Cmax) in Whole Blood and Plasma | Predose, Up to 4 hours postdose | ||
| Secondary | Time to Maximum Concentration (Tmax) in Whole Blood and Plasma | Predose, Up to 4 hours postdose | ||
| Secondary | Number of Participants Who Test Positive for Antidrug Antibodies (ADAs) to AB598 | Up to 2 years | ||
| Secondary | Objective Response Rate (ORR) | Up to 2 years | ||
| Secondary | Dose Expansion Cohorts: Duration of Response (DOR) | Up to 2 years |
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