A Study to Evaluate AB308 in Combination With AB122 in Participants With Advanced Malignancies
- Conditions
- MelanomaAdvanced Solid TumorEsophageal CancerNon Small Cell Lung Cancer (NSCLC)Multiple MyelomaCervical CancerLymphoma, Non-HodgkinDiffuse Large B Cell Lymphoma (DLBCL)Gastroesophageal Junction AdenocarcinomaGastric Cancer
- Interventions
- Registration Number
- NCT04772989
- Lead Sponsor
- Arcus Biosciences, Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 94
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Dose Escalation Q3W Cohorts AB308 Escalating doses of AB308 in combination with zimberelimab (360 mg) will be given every 3 weeks in participants with advanced malignancies. Dose Escalation Q4W Cohorts AB308 Escalating doses of AB308 in combination with zimberelimab (480 mg) will be given every 4 weeks in participants with advanced malignancies. Dose Escalation Q6W Cohort AB308 Selected dose of AB308 in combination with zimberelimab will be given every 6 weeks in participants with advanced malignancies. Dose Escalation Q6W Cohort Zimberelimab Selected dose of AB308 in combination with zimberelimab will be given every 6 weeks in participants with advanced malignancies. Dose Expansion Cohort 1 AB308 AB308 will be given in combination with zimberelimab at 360 mg or 480 mg Q3W or Q4W, respectively, in participants with in participants with locally advanced or metastatic NSCLC. Dose Expansion Cohort 1 Zimberelimab AB308 will be given in combination with zimberelimab at 360 mg or 480 mg Q3W or Q4W, respectively, in participants with in participants with locally advanced or metastatic NSCLC. Dose Expansion Cohort 2 AB308 AB308 will be given in combination with zimberelimab at 360 mg or 480 mg Q3W or Q4W, respectively, in participants with melanoma. Dose Expansion Cohort 2 Zimberelimab AB308 will be given in combination with zimberelimab at 360 mg or 480 mg Q3W or Q4W, respectively, in participants with melanoma. Dose Expansion Cohort 3 AB308 AB308 will be given in combination with zimberelimab at 360 mg or 480 mg Q3W or Q4W, respectively, in participants with metastatic gastric, or gastroesophageal junction, or esophageal cancer. Dose Expansion Cohort 4 AB308 AB308 will be given in combination with zimberelimab at 360 mg or 480 mg Q3W or Q4W, respectively, in participants with cervical cancer. Dose Expansion Cohort 5 AB308 AB308 will be given in combination with zimberelimab at 360 mg or 480 mg Q3W or Q4W, respectively, in participants with hematological malignancies. Dose Expansion Cohort 5 Zimberelimab AB308 will be given in combination with zimberelimab at 360 mg or 480 mg Q3W or Q4W, respectively, in participants with hematological malignancies. Dose Escalation Q3W Cohorts Zimberelimab Escalating doses of AB308 in combination with zimberelimab (360 mg) will be given every 3 weeks in participants with advanced malignancies. Dose Escalation Q4W Cohorts Zimberelimab Escalating doses of AB308 in combination with zimberelimab (480 mg) will be given every 4 weeks in participants with advanced malignancies. Dose Expansion Cohort 3 Zimberelimab AB308 will be given in combination with zimberelimab at 360 mg or 480 mg Q3W or Q4W, respectively, in participants with metastatic gastric, or gastroesophageal junction, or esophageal cancer. Dose Expansion Cohort 4 Zimberelimab AB308 will be given in combination with zimberelimab at 360 mg or 480 mg Q3W or Q4W, respectively, in participants with cervical cancer.
- Primary Outcome Measures
Name Time Method Percentage of participants with Adverse Events From first study treatment administration until up to 90 days after the last dose (Approximately 1 year) 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 Outcome Measures
Name Time Method 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) 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) 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) 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) 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) 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) 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)
Trial Locations
- Locations (22)
University of Wisconsin - Madison
🇺🇸Madison, Wisconsin, United States
Ohio State University Comprehensive Cancer Center
🇺🇸Columbus, Ohio, United States
Virginia Cancer Specialists
🇺🇸Fairfax, Virginia, United States
Med-Polonia Sp. z o.o.
🇵🇱Poznan, Poland
Holden Comprehensive Cancer Center
🇺🇸Iowa City, Iowa, United States
Goshen Health System
🇺🇸Goshen, Indiana, United States
Clínica Universidad de Navarra
🇪🇸Pamplona, Spain
Mayo Clinic Jacksonville - PPDS
🇺🇸Jacksonville, Florida, United States
Specjalistyczna Praktyka Lekarska Slawomir Mandziuk
🇵🇱Lubin, Poland
UCLA Department of Medicine - Hematology/Oncology
🇺🇸Los Angeles, California, United States
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
START South Texas Accelerated Research Therapeutics - Mountain Region
🇺🇸West Valley City, Utah, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
START MADRID Hospital Unviersitario Fundacion Jimenez Diaz
🇪🇸Madrid, Spain
Clínica Universidad de Navarra - Madrid
🇪🇸Madrid, Spain
Hospital Universitario Vall d'Hebron
🇪🇸Barcelona, Spain
University of Oklahoma Peggy and Charles Stephenson Cancer Center
🇺🇸Oklahoma City, Oklahoma, United States
Tennessee Onocology - Nashville
🇺🇸Nashville, Tennessee, United States
START South Texas Accelerated Research Therapeutics
🇺🇸San Antonio, Texas, United States
Norton Cancer Insititute-Downtown
🇺🇸Louisville, Kentucky, United States
Mayo Clinic Rochester
🇺🇸Rochester, Minnesota, United States