Clinical Trials /

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

NCT04772989

Description:

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.

Related Conditions:
  • Malignant Solid Tumor
  • Non-Hodgkin Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: 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

Clinical Trial IDs

  • ORG STUDY ID: ARC-12
  • NCT ID: NCT04772989

Conditions

  • Advanced Solid Tumor
  • NSCLC
  • Melanoma
  • Cervical Cancer
  • Multiple Myeloma
  • Lymphoma, Non-Hodgkin
  • DLBCL
  • Gastric Cancer
  • Gastroesophageal Junction Adenocarcinoma
  • Esophageal Cancer

Interventions

DrugSynonymsArms
AB308Dose Escalation Q3W Cohorts
ZimberelimabAB122Dose Escalation Q3W Cohorts

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Dose Escalation Q3W CohortsExperimentalEscalating doses of AB308 in combination with zimberelimab (360 mg) will be given every 3 weeks in participants with advanced malignancies.
  • AB308
  • Zimberelimab
Dose Escalation Q4W CohortsExperimentalEscalating doses of AB308 in combination with zimberelimab (480 mg) will be given every 4 weeks in participants with advanced malignancies.
  • AB308
  • Zimberelimab
Dose Expansion Cohort 1ExperimentalAB308 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
  • Zimberelimab
Dose Expansion Cohort 2ExperimentalAB308 will be given in combination with zimberelimab at 360 mg or 480 mg Q3W or Q4W, respectively, in participants with melanoma.
  • AB308
  • Zimberelimab
Dose Expansion Cohort 3ExperimentalAB308 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
  • Zimberelimab
Dose Expansion Cohort 4ExperimentalAB308 will be given in combination with zimberelimab at 360 mg or 480 mg Q3W or Q4W, respectively, in participants with cervical cancer.
  • AB308
  • Zimberelimab
Dose Expansion Cohort 5ExperimentalAB308 will be given in combination with zimberelimab at 360 mg or 480 mg Q3W or Q4W, respectively, in participants with hematological malignancies.
  • AB308
  • Zimberelimab

Eligibility Criteria

        -  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 unable to receive stem cell transplant or adoptive cell 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 unable to receive stem cell transplant or adoptive cell
                  transfer, or

               -  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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure: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)
Safety Issue:
Description:

Secondary Outcome Measures

Measure: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) )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).
Safety Issue:
Description:
Measure: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) 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).
Safety Issue:
Description:
Measure:Percentage of participants with anti-drug antibodies to AB308
Time Frame: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).
Safety Issue:
Description:
Measure:Percentage of participants with anti-drug antibodies to zimberelimab
Time Frame: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).
Safety Issue:
Description:
Measure: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)
Safety Issue:
Description:
Measure: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)
Safety Issue:
Description:
Measure: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)
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Arcus Biosciences, Inc.

Last Updated

April 8, 2021