A Study to Evaluate AB308 in Combination With AB122 in Participants With Advanced Malignancies

Multiple Myeloma Clinical Trial

— ARC-12  

Official title:

A Phase 1/1b Study to Evaluate the Safety and Tolerability of AB308 in Combination With AB122 in Participants With Advanced Malignancies

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04772989
• Other study ID #: ARC-12
• Secondary ID: 2021-005589-16
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: March 19, 2021
• Est. completion date: January 2025

Study information

• Verified date: March 2024
• Source: Arcus Biosciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Phase 1/1b, multicenter, open-label, dose-escalation, and dose-expansion study to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and clinical activity of AB308 in combination with zimberelimab (AB122) in participants with advanced malignancies.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 94
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
• Male or female participants = 18 years of age (or age = regionally approved age of consent for participation in investigational clinical studies) at the time of signing the informed consent.
• Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
• Adequate organ and marrow function

Exclusion Criteria:

• History of trauma or major surgery within 28 days prior to the first dose of study treatment.
• Prior treatment with an anti-TIGIT antibody.
• Any active or prior autoimmune disease that required treatment within 3 years of the first dose of study treatment.
• Prior chemotherapy, targeted small-molecule therapy, immunotherapy, or biologic agents, or use of other investigational drugs within 28 days before first dose of study treatment.
• Discontinued prior immunotherapy for immune related adverse events with a high severity. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Cervical Cancer
• Diffuse Large B Cell Lymphoma (DLBCL)
• Esophageal Cancer
• Gastric Cancer
• Gastroesophageal Junction Adenocarcinoma
• Lymphoma
• Lymphoma, Large B-Cell, Diffuse
• Lymphoma, Non-Hodgkin
• Melanoma
• Multiple Myeloma
• Non Small Cell Lung Cancer (NSCLC)

Intervention

Drug:
• AB308
Administered intravenously (IV) as specified in the treatment arm
• Zimberelimab
Administered IV as specified in the treatment arm

Locations

Country	Name	City	State
Poland	Jagiellonskie Centrum Innowacji	Kraków
Poland	Specjalistyczna Praktyka Lekarska Slawomir Mandziuk	Lubin
Poland	SPZOZ MiSWiA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie	Olsztyn
Poland	Med-Polonia Sp. z o.o.	Poznan
Poland	Narodowy Instytut Onkologii	Warszawa
Spain	Hospital Universitario Vall d'Hebron	Barcelona
Spain	Clínica Universidad de Navarra	Madrid
Spain	START MADRID_Hospital Universitario HM Sanchinarro - CIOCC	Madrid
United States	Augusta Oncology Associates - Wheeler Road	Augusta	Georgia
United States	University of Colorado - Cancer Center - PPDS	Aurora	Colorado
United States	Gabrail Cancer Center	Canton	Ohio
United States	Ohio State University	Columbus	Ohio
United States	Virginia Cancer Specialists	Fairfax	Virginia
United States	Goshen Health System	Goshen	Indiana
United States	Holden Comprehensive Cancer Center	Iowa City	Iowa
United States	Mayo Clinic Jacksonville - PPDS	Jacksonville	Florida
United States	University of California, Los Angeles	Los Angeles	California
United States	Norton Cancer Institute-Downtown	Louisville	Kentucky
United States	University of Wisconsin - Madison	Madison	Wisconsin
United States	Tennessee Onocology - Nashville	Nashville	Tennessee
United States	Columbia University Medical Center	New York	New York
United States	Henry Ford Health System	Novi	Michigan
United States	University of Oklahoma Peggy and Charles Stephenson Cancer Center	Oklahoma City	Oklahoma
United States	AdventHealth Orlando	Orlando	Florida
United States	Mayo Clinic Arizona - Mayo Clinic Hospital	Phoenix	Arizona
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Mayo Clinic - PPDS	Rochester	Minnesota
United States	START South Texas Accelerated Research Therapeutics - San Antonio	San Antonio	Texas
United States	START South Texas Accelerated Research Therapeutics - Mountain Region	West Valley City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
Arcus Biosciences, Inc.	Gilead Sciences

Countries where clinical trial is conducted

United States,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants with Adverse Events		From first study treatment administration until up to 90 days after the last dose (Approximately 1 year)
Primary	Percentage of participants who experience a Dose Limiting Toxicity		From first study treatment administration through Day 21 (Q3W arm) or Day 28 (Q4W arm) or Day 42 (Q6W arm)
Secondary	Serum concentration of AB308		Recorded at baseline (day 1 of cycle 1), during each of the first 5 cycles (each cycle is 21 days or 28 days or 42 days) and up to the first 16 cycles of treatment (up to 22 months), and 30 and 90 days post last dose (up to approximately 25 months)
Secondary	Serum concentration of zimberelimab		Recorded at baseline (day 1 of cycle 1), during each of the first 5 cycles (each cycle is 21 days or 28 days or 42 days) and up to the first 16 cycles of treatment (up to 22 months), and 30 and 90 days post last dose (up to approximately 25 months)
Secondary	Percentage of participants with anti-drug antibodies to AB308		Recorded at baseline (day 1 of cycle 1), during each of the first 5 cycles (each cycle is 21 days or 28 days or 42 days) and up to the first 16 cycles of treatment (up to 22 months), and 30 and 90 days post last dose (up to approximately 25 months)
Secondary	Percentage of participants with anti-drug antibodies to zimberelimab		Recorded at baseline (day 1 of cycle 1), during each of the first 5 cycles (each cycle is 21 days or 28 days or 42 days) and up to the first 16 cycles of treatment (up to 22 months), and 30 and 90 days post last dose (up to approximately 25 months)
Secondary	Percentage of participants with Objective Response		From study enrollment until participant discontinuation, first occurrence of progressive disease, or death from any cause, whichever occurs first (up to approximately 3-5 years)
Secondary	Duration of Response		From the date of first occurrence of a documented objective response to first documentation of disease progression or death from any cause, whichever occurs first (up to approximately 3-5 years)
Secondary	Percentage of Participants with Disease Control (complete response, partial response, or stable disease) for >6 months		From study enrollment until disease progression or loss of clinical benefit (up to approximately 3-5 years)