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

Sponsor
Arcus Biosciences, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04772989
Collaborator
(none)
154
Enrollment
20
Locations
7
Arms
32.4
Anticipated Duration (Months)
7.7
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
154 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1/1b Study to Evaluate the Safety and Tolerability of AB308 in Combination With AB122 in Participants With Advanced Malignancies
Actual Study Start Date :
Mar 19, 2021
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

ArmIntervention/Treatment
Experimental: Dose Escalation Q3W Cohorts

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

Drug: AB308
Administered as specified in the treatment arm

Drug: Zimberelimab
Administered as specified in the treatment arm
Other Names:
  • AB122
  • Experimental: Dose Escalation Q4W Cohorts

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

    Drug: AB308
    Administered as specified in the treatment arm

    Drug: Zimberelimab
    Administered as specified in the treatment arm
    Other Names:
  • AB122
  • Experimental: Dose Expansion Cohort 1

    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.

    Drug: AB308
    Administered as specified in the treatment arm

    Drug: Zimberelimab
    Administered as specified in the treatment arm
    Other Names:
  • AB122
  • Experimental: Dose Expansion Cohort 2

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

    Drug: AB308
    Administered as specified in the treatment arm

    Drug: Zimberelimab
    Administered as specified in the treatment arm
    Other Names:
  • AB122
  • Experimental: Dose Expansion Cohort 3

    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.

    Drug: AB308
    Administered as specified in the treatment arm

    Drug: Zimberelimab
    Administered as specified in the treatment arm
    Other Names:
  • AB122
  • Experimental: Dose Expansion Cohort 4

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

    Drug: AB308
    Administered as specified in the treatment arm

    Drug: Zimberelimab
    Administered as specified in the treatment arm
    Other Names:
  • AB122
  • Experimental: Dose Expansion Cohort 5

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

    Drug: AB308
    Administered as specified in the treatment arm

    Drug: Zimberelimab
    Administered as specified in the treatment arm
    Other Names:
  • AB122
  • Outcome Measures

    Primary Outcome Measures

    1. Percentage of participants with Adverse Events [From first study treatment administration until up to 90 days after the last dose (Approximately 1 year)]

    2. Percentage of participants who experience a Dose Limiting Toxicity [From first study treatment administration through Day 21 (Q3W arm) or Day 28 (Q4W arm)]

    Secondary Outcome Measures

    1. 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) )and up to the first 16 cycles of treatment (up to 15 months), and 30 and 90 days post last dose (i.e. in total up to approximately 18 months).]

    2. 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) and up to the first 16 cycles of treatment (up to 15 months), and 30 and 90 days post last dose (i.e. in total up to approximately 18 months).]

    3. Percentage of participants with anti-drug antibodies to AB308 [Recorded at baseline (day 1 of cycle 1), during each of the first 4 cycles (each cycle is 21 days or 28 days) and up to the first 16 cycles of treatment (up to 15 months), and 30 and 90 days post last dose (i.e. in total up to approximately 18 months).]

    4. Percentage of participants with anti-drug antibodies to zimberelimab [Recorded at baseline (day 1 of cycle 1), during each of the first 4 cycles (each cycle is 21 days or 28 days) and up to the first 16 cycles of treatment (up to 15 months), and 30 and 90 days post last dose (i.e. in total up to approximately 18 months).]

    5. 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)]

    6. 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)]

    7. 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)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    • Performance status score of 0 or 1

    • Measurable disease as per radiographic evaluation

    • Disease-specific criteria for dose escalation:

    • Participants with any type of solid tumor for which no treatment is currently available, or

    • Participants with non-Hodgkin Lymphoma that has progressed on prior chemotherapy and have not or are unable to receive stem cell transplant. transfer

    • Participants may have received up to 5 prior anti-cancer therapies and an unlimited number of prior hormonal therapies.

    • Disease-specific criteria for dose-expansion Cohort 1:

    • Participants with previously untreated locally advanced or metastatic NSCLC with a high PD-L1 expression

    • Disease-specific criteria for dose-expansion Cohort 2:

    • Participants with metastatic melanoma with at least one prior anti-cancer therapy and progression after PD-L1 therapy

    • Disease-specific criteria for dose-expansion Cohort 3:

    • Participants with metastatic gastric, or gastroesophageal junction, or esophageal cancer with at least 1 prior chemotherapy and no prior PD-(L)1 therapy.

    • Disease-specific criteria for dose-expansion Cohort 4:

    • Participants with metastatic cervical cancer with at least 1 prior chemotherapy and no prior PD-(L)1 therapy.

    • Disease-specific criteria for dose-expansion Cohort 5

    • Participants with diffuse large B-cell lymphoma (DLBCL) with at least 2 prior anti-cancer therapies and have not or are unable to receive allogenic stem cell transplant

    • Participants with multiple myeloma with at least 3 prior anti-cancer therapies and for whom no treatment is currently available.

    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.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Investigator SitePhoenixArizonaUnited States85054-4502
    2University of California, Los AngelesLos AngelesCaliforniaUnited States90095
    3Investigator SiteAuroraColoradoUnited States80045-2545
    4Investigator SitesJacksonvilleFloridaUnited States32224
    5Investigator SiteOrlandoFloridaUnited States43210
    6Investigator SiteAugustaGeorgiaUnited States30909-6520
    7Goshen Health SystemGoshenIndianaUnited States46526
    8Investigator SiteIowa CityIowaUnited States52242-1009
    9Investigator SiteLouisvilleKentuckyUnited States40202-3700
    10Henry Ford Health SystemNoviMichiganUnited States48377
    11Investigator SiteRochesterMinnesotaUnited States55905
    12Investigator SiteNew YorkNew YorkUnited States10032-3729
    13Ohio State UniversityColumbusOhioUnited States43210
    14University of Oklahoma Peggy and Charles Stephenson Cancer CenterOklahoma CityOklahomaUnited States73104
    15University of Pittsburgh Medical CenterPittsburghPennsylvaniaUnited States15240
    16Tennessee Onocology - NashvilleNashvilleTennesseeUnited States37205
    17START South Texas Accelerated Research Therapeutics - San AntonioSan AntonioTexasUnited States78229
    18START South Texas Accelerated Research Therapeutics - Mountain RegionWest Valley CityUtahUnited States84119
    19Virginia Cancer SpecialistsFairfaxVirginiaUnited States22031
    20University of Wisconsin - MadisonMadisonWisconsinUnited States53792

    Sponsors and Collaborators

    • Arcus Biosciences, Inc.

    Investigators

    • Study Director: Medical Director, Arcus Biosciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Arcus Biosciences, Inc.
    ClinicalTrials.gov Identifier:
    NCT04772989
    Other Study ID Numbers:
    • ARC-12
    First Posted:
    Feb 26, 2021
    Last Update Posted:
    Oct 7, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 7, 2021