Advanced Solid Tumor, Cervical Cancer, Diffuse Large B Cell Lymphoma (DLBCL), Esophageal Cancer, Gastric Cancer, Gastroesophageal Junction Adenocarcinoma, Lymphoma, Non-Hodgkin, Melanoma, Multiple Myeloma, Non Small Cell Lung Cancer (NSCLC)
Conditions
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.
Interventions
DRUGAB308
Administered intravenously (IV) as specified in the treatment arm
DRUGZimberelimab
Administered IV as specified in the treatment arm
Sponsors
Gilead Sciences
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
* 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 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) |
| 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) |
| 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) |
Countries
Poland, Spain, United States
Outcome results
None listed