Clinical trial NCT04772989: A Study to Evaluate AB308 in Combination With AB122 in Participants With Advanced Malignancies
Official title: A Phase 1/1b Study to Evaluate the Safety and Tolerability of AB308 in Combination With AB122 in Participants With Advanced Malignancies
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Advanced Solid Tumor
Non Small Cell Lung Cancer (NSCLC)
Melanoma
Cervical Cancer
Multiple Myeloma
Lymphoma, Non-Hodgkin
Diffuse Large B Cell Lymphoma (DLBCL)
Gastric Cancer
Gastroesophageal Junction Adenocarcinoma
Esophageal Cancer
Lead sponsor: Arcus Biosciences, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Gilead Sciences
First posted: 2021-02-26
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of participants with Adverse Events
timeFrame: From first study treatment administration until up to 90 days after the last dose (Approximately 1 year)
measure: Percentage of participants who experience a Dose Limiting Toxicity
timeFrame: From first study treatment administration through Day 21 (Q3W arm) or Day 28 (Q4W arm) or Day 42 (Q6W arm)
Secondary outcomes:
measure: Serum concentration of AB308
timeFrame: 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)
measure: Serum concentration of zimberelimab
timeFrame: 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)
measure: Percentage of participants with anti-drug antibodies to AB308
timeFrame: 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)
measure: Percentage of participants with anti-drug antibodies to zimberelimab
timeFrame: 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)
measure: Percentage of participants with Objective Response
timeFrame: 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)
measure: Duration of Response
timeFrame: 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)
measure: Percentage of Participants with Disease Control (complete response, partial response, or stable disease) for >6 months
timeFrame: From study enrollment until disease progression or loss of clinical benefit (up to approximately 3-5 years)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Department of Medicine - Hematology/Oncology
state: California
city: Jacksonville
country: United States
facility: Mayo Clinic Jacksonville - PPDS
state: Florida
city: Goshen
country: United States
facility: Goshen Health System
state: Indiana
city: Iowa City
country: United States
facility: Holden Comprehensive Cancer Center
state: Iowa
city: Louisville
country: United States
facility: Norton Cancer Insititute-Downtown
state: Kentucky
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma Peggy and Charles Stephenson Cancer Center
state: Oklahoma
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Nashville
country: United States
facility: Tennessee Onocology - Nashville
state: Tennessee
city: San Antonio
country: United States
facility: START South Texas Accelerated Research Therapeutics
state: Texas
city: West Valley City
country: United States
facility: START South Texas Accelerated Research Therapeutics - Mountain Region
state: Utah
city: Fairfax
country: United States
facility: Virginia Cancer Specialists
state: Virginia
city: Madison
country: United States
facility: University of Wisconsin - Madison
state: Wisconsin
city: Lubin
country: Poland
facility: Specjalistyczna Praktyka Lekarska Slawomir Mandziuk
city: Poznan
country: Poland
facility: Med-Polonia Sp. z o.o.
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron
city: Madrid
country: Spain
facility: Clínica Universidad de Navarra - Madrid
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: START MADRID Hospital Unviersitario Fundacion Jimenez Diaz
city: Pamplona
country: Spain
facility: Clínica Universidad de Navarra
Study officials:
affiliation: Arcus Biosciences
name: Medical Director
role: STUDY_DIRECTOR
References: