search
Back to results

A Study to Evaluate AB308 in Combination With AB122 in Participants With Advanced Malignancies (ARC-12)

Primary Purpose

Advanced Solid Tumor, NSCLC, Melanoma

Status
Active
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
AB308
Zimberelimab
Sponsored by
Arcus Biosciences, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Solid Tumor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

General 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.

Sites / Locations

  • Mayo Clinic Arizona - Mayo Clinic Hospital
  • University of California, Los Angeles
  • University of Colorado - Cancer Center - PPDS
  • Mayo Clinic Jacksonville - PPDS
  • AdventHealth Orlando
  • Augusta Oncology Associates - Wheeler Road
  • Goshen Health System
  • Holden Comprehensive Cancer Center
  • Norton Cancer Institute-Downtown
  • Henry Ford Health System
  • Mayo Clinic - PPDS
  • Columbia University Medical Center
  • Gabrail Cancer Center
  • Ohio State University
  • University of Oklahoma Peggy and Charles Stephenson Cancer Center
  • University of Pittsburgh Medical Center
  • Tennessee Onocology - Nashville
  • START South Texas Accelerated Research Therapeutics - San Antonio
  • START South Texas Accelerated Research Therapeutics - Mountain Region
  • Virginia Cancer Specialists
  • University of Wisconsin - Madison
  • Jagiellonskie Centrum Innowacji
  • Specjalistyczna Praktyka Lekarska Slawomir Mandziuk
  • SPZOZ MiSWiA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie
  • Med-Polonia Sp. z o.o.
  • Narodowy Instytut Onkologii
  • Hospital Universitario Vall d'Hebron
  • Clínica Universidad de Navarra
  • START MADRID_Hospital Universitario HM Sanchinarro - CIOCC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Dose Escalation Q3W Cohorts

Dose Escalation Q4W Cohorts

Dose Escalation Q6W Cohort

Dose Expansion Cohort 1

Dose Expansion Cohort 2

Dose Expansion Cohort 3

Dose Expansion Cohort 4

Dose Expansion Cohort 5

Arm Description

Escalating doses of AB308 in combination with zimberelimab (360 mg) will be given every 3 weeks in participants with advanced malignancies.

Escalating doses of AB308 in combination with zimberelimab (480 mg) will be given every 4 weeks in participants with advanced malignancies.

Selected dose of AB308 in combination with zimberelimab will be given every 6 weeks in participants with advanced malignancies.

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.

AB308 will be given in combination with zimberelimab at 360 mg or 480 mg Q3W or Q4W, respectively, in participants with melanoma.

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.

AB308 will be given in combination with zimberelimab at 360 mg or 480 mg Q3W or Q4W, respectively, in participants with cervical cancer.

AB308 will be given in combination with zimberelimab at 360 mg or 480 mg Q3W or Q4W, respectively, in participants with hematological malignancies.

Outcomes

Primary Outcome Measures

Percentage of participants with Adverse Events
Percentage of participants who experience a Dose Limiting Toxicity

Secondary Outcome Measures

Serum concentration of AB308
Serum concentration of zimberelimab
Percentage of participants with anti-drug antibodies to AB308
Percentage of participants with anti-drug antibodies to zimberelimab
Percentage of participants with Objective Response
Duration of Response
Percentage of Participants with Disease Control (complete response, partial response, or stable disease) for >6 months

Full Information

First Posted
February 22, 2021
Last Updated
September 19, 2023
Sponsor
Arcus Biosciences, Inc.
Collaborators
Gilead Sciences
search

1. Study Identification

Unique Protocol Identification Number
NCT04772989
Brief Title
A Study to Evaluate AB308 in Combination With AB122 in Participants With Advanced Malignancies
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 19, 2021 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arcus Biosciences, Inc.
Collaborators
Gilead Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Solid Tumor, NSCLC, Melanoma, Cervical Cancer, Multiple Myeloma, Lymphoma, Non-Hodgkin, DLBCL, Gastric Cancer, Gastroesophageal Junction Adenocarcinoma, Esophageal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
94 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dose Escalation Q3W Cohorts
Arm Type
Experimental
Arm Description
Escalating doses of AB308 in combination with zimberelimab (360 mg) will be given every 3 weeks in participants with advanced malignancies.
Arm Title
Dose Escalation Q4W Cohorts
Arm Type
Experimental
Arm Description
Escalating doses of AB308 in combination with zimberelimab (480 mg) will be given every 4 weeks in participants with advanced malignancies.
Arm Title
Dose Escalation Q6W Cohort
Arm Type
Experimental
Arm Description
Selected dose of AB308 in combination with zimberelimab will be given every 6 weeks in participants with advanced malignancies.
Arm Title
Dose Expansion Cohort 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Dose Expansion Cohort 2
Arm Type
Experimental
Arm Description
AB308 will be given in combination with zimberelimab at 360 mg or 480 mg Q3W or Q4W, respectively, in participants with melanoma.
Arm Title
Dose Expansion Cohort 3
Arm Type
Experimental
Arm Description
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.
Arm Title
Dose Expansion Cohort 4
Arm Type
Experimental
Arm Description
AB308 will be given in combination with zimberelimab at 360 mg or 480 mg Q3W or Q4W, respectively, in participants with cervical cancer.
Arm Title
Dose Expansion Cohort 5
Arm Type
Experimental
Arm Description
AB308 will be given in combination with zimberelimab at 360 mg or 480 mg Q3W or Q4W, respectively, in participants with hematological malignancies.
Intervention Type
Drug
Intervention Name(s)
AB308
Intervention Description
Administered intravenously (IV) as specified in the treatment arm
Intervention Type
Drug
Intervention Name(s)
Zimberelimab
Other Intervention Name(s)
AB122
Intervention Description
Administered IV as specified in the treatment arm
Primary Outcome Measure Information:
Title
Percentage of participants with Adverse Events
Time Frame
From first study treatment administration until up to 90 days after the last dose (Approximately 1 year)
Title
Percentage of participants who experience a Dose Limiting Toxicity
Time Frame
From first study treatment administration through Day 21 (Q3W arm) or Day 28 (Q4W arm) or Day 42 (Q6W arm)
Secondary Outcome Measure Information:
Title
Serum concentration of AB308
Time Frame
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)
Title
Serum concentration of zimberelimab
Time Frame
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)
Title
Percentage of participants with anti-drug antibodies to AB308
Time Frame
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)
Title
Percentage of participants with anti-drug antibodies to zimberelimab
Time Frame
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)
Title
Percentage of participants with Objective Response
Time Frame
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)
Title
Duration of Response
Time Frame
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)
Title
Percentage of Participants with Disease Control (complete response, partial response, or stable disease) for >6 months
Time Frame
From study enrollment until disease progression or loss of clinical benefit (up to approximately 3-5 years)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Arcus Biosciences
Official's Role
Study Director
Facility Information:
Facility Name
Mayo Clinic Arizona - Mayo Clinic Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054-4502
Country
United States
Facility Name
University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
University of Colorado - Cancer Center - PPDS
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045-2545
Country
United States
Facility Name
Mayo Clinic Jacksonville - PPDS
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
AdventHealth Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
43210
Country
United States
Facility Name
Augusta Oncology Associates - Wheeler Road
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909-6520
Country
United States
Facility Name
Goshen Health System
City
Goshen
State/Province
Indiana
ZIP/Postal Code
46526
Country
United States
Facility Name
Holden Comprehensive Cancer Center
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Norton Cancer Institute-Downtown
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Henry Ford Health System
City
Novi
State/Province
Michigan
ZIP/Postal Code
48377
Country
United States
Facility Name
Mayo Clinic - PPDS
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032-3729
Country
United States
Facility Name
Gabrail Cancer Center
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
University of Oklahoma Peggy and Charles Stephenson Cancer Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15240
Country
United States
Facility Name
Tennessee Onocology - Nashville
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
START South Texas Accelerated Research Therapeutics - San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
START South Texas Accelerated Research Therapeutics - Mountain Region
City
West Valley City
State/Province
Utah
ZIP/Postal Code
84119
Country
United States
Facility Name
Virginia Cancer Specialists
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22033-1712
Country
United States
Facility Name
University of Wisconsin - Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Jagiellonskie Centrum Innowacji
City
Kraków
Country
Poland
Facility Name
Specjalistyczna Praktyka Lekarska Slawomir Mandziuk
City
Lubin
Country
Poland
Facility Name
SPZOZ MiSWiA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie
City
Olsztyn
Country
Poland
Facility Name
Med-Polonia Sp. z o.o.
City
Poznań
Country
Poland
Facility Name
Narodowy Instytut Onkologii
City
Warszawa
Country
Poland
Facility Name
Hospital Universitario Vall d'Hebron
City
Barcelona
Country
Spain
Facility Name
Clínica Universidad de Navarra
City
Madrid
Country
Spain
Facility Name
START MADRID_Hospital Universitario HM Sanchinarro - CIOCC
City
Madrid
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Arcus will provide access to individual de-identified participant data and related study documents (e.g., protocol, Statistical Analysis Plan [SAP], Clinical Study Report [CSR]) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. For more information, please visit our website.
IPD Sharing URL
https://trials.arcusbio.com/our-transparency-policy

Learn more about this trial

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

We'll reach out to this number within 24 hrs