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Study of AB598 Monotherapy and Combination Therapy in Participants With Advanced Cancers (ARC-25)

Primary Purpose

Advanced Cancer, Advanced Malignancies, Bladder Cancer

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
AB598
Zimberelimab
Carboplatin
Pemetrexed
Fluorouracil
Leucovorin
Oxaliplatin
Sponsored by
Arcus Biosciences, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Cancer focused on measuring AB598, AB122, Zimberelimab

Eligibility Criteria

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

Key Inclusion Criteria: Must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) guidance Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 Monotherapy-specific criteria for dose escalation cohorts: Participants may have pathologically confirmed NSCLC, gastric/GEJ, esophageal, HNSCC, bladder, RCC, TNBC, cervical, and ovarian cancers for which standard therapy has proven ineffective, intolerable, or considered inappropriate Disease-specific criteria for dose-expansion Cohort 1 (NSCLC): Histologically confirmed, documented diagnosis of locally advanced unresectable or metastatic non-squamous NSCLC Treatment-naive in the unresectable locally advanced or metastatic setting Cannot have progressed within 6 months of prior platinum-based chemotherapy Mixed small-cell lung cancer histology is not permitted Disease-specific criteria for dose expansion Cohort 2 (Gastric/GEJ): Histologically confirmed, documented diagnosis of human epidermal growth factor 2 (HER2)-negative locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma No prior systemic treatment for locally advanced unresectable or metastatic disease Cannot have progressed within 6 months of prior platinum-based chemotherapy Key Exclusion Criteria: Use of any live vaccines against infectious diseases (eg, influenza, varicella) within 4 weeks (28 days) of initiation of study Underlying medical conditions or AEs that, in the investigator's or sponsor's opinion, will make the administration of the study drugs hazardous Any active or documented history of autoimmune disease including but not limited to inflammatory bowel disease, celiac disease, Wegner syndrome, Hashimoto syndrome, systemic lupus erythematosus, scleroderma, sarcoidosis, or autoimmune hepatitis, within 3 years of the first dose of study treatment History of trauma or major surgery within 28 days prior to the first dose of study drug Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressant medication during study treatment with certain protocol specified exceptions Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Sites / Locations

  • Affinity Health-Hope and Healing Cancer Services, LLCRecruiting
  • Gabrail Cancer CenterRecruiting
  • Next Oncology DallasRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Dose Escalation Cohort 1

Dose Escalation Cohort 2

Dose Escalation Cohort 3

Dose Escalation Cohort 4

Dose Expansion Cohort 1 NSCLC

Dose Expansion Cohort 2 Gastric/GEJ Cancer

Arm Description

Participants will receive AB598 intravenous (IV) infusion once every 3 weeks

Participants will receive AB598 IV infusion once every 3 weeks

Participants will receive AB598 IV infusion once every 3 weeks

Participants will receive AB598 IV infusion once every 3 weeks

Participants will receive AB598 IV infusion in combination with zimberelimab and carboplatin/pemetrexed once every 3 weeks, for up to 2 years

Participants will receive AB598 IV infusion in combination with zimberelimab once every 3 weeks, and FOLFOX (oxaliplatin, leucovorin, fluorouracil) every 2 weeks, for up to 2 years

Outcomes

Primary Outcome Measures

Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Dose Escalation Cohorts: Number of Participants with Dose-Limiting Toxicities (DLTs)

Secondary Outcome Measures

Area Under the Concentration-Time Curve from Administration ("0") to the Time That the Drug is No Longer Present in the Body ("infinity") (AUC 0-inf) in Whole Blood and Plasma
Maximum Concentration (Cmax) in Whole Blood and Plasma
Time to Maximum Concentration (Tmax) in Whole Blood and Plasma
Number of Participants Who Test Positive for Antidrug Antibodies (ADAs) to AB598
Objective Response Rate (ORR)
Dose Expansion Cohorts: Duration of Response (DOR)

Full Information

First Posted
May 26, 2023
Last Updated
October 20, 2023
Sponsor
Arcus Biosciences, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05891171
Brief Title
Study of AB598 Monotherapy and Combination Therapy in Participants With Advanced Cancers
Acronym
ARC-25
Official Title
A Phase 1/1b Study to Evaluate the Safety and Tolerability of AB598 Monotherapy and Combination Therapy in Participants With Advanced Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 13, 2023 (Actual)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
August 2025 (Anticipated)

3. Sponsor/Collaborators

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

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
The primary purpose of this study is to assess the safety and tolerability of AB598 when taken alone, and in combination with zimberelimab and standard chemotherapy 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 Cancer, Advanced Malignancies, Bladder Cancer, Cervical Cancer, Esophageal Cancer, Gastric Cancer, Gastroesophageal-junction Cancer (GEJ), Head and Neck Squamous Cell Carcinoma (HNSCC), Non-Small Cell Lung Cancer (NSCLC), Ovarian Cancer, Renal Cell Carcinoma (RCC), Triple Negative Breast Cancer (TNBC)
Keywords
AB598, AB122, Zimberelimab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
81 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dose Escalation Cohort 1
Arm Type
Experimental
Arm Description
Participants will receive AB598 intravenous (IV) infusion once every 3 weeks
Arm Title
Dose Escalation Cohort 2
Arm Type
Experimental
Arm Description
Participants will receive AB598 IV infusion once every 3 weeks
Arm Title
Dose Escalation Cohort 3
Arm Type
Experimental
Arm Description
Participants will receive AB598 IV infusion once every 3 weeks
Arm Title
Dose Escalation Cohort 4
Arm Type
Experimental
Arm Description
Participants will receive AB598 IV infusion once every 3 weeks
Arm Title
Dose Expansion Cohort 1 NSCLC
Arm Type
Experimental
Arm Description
Participants will receive AB598 IV infusion in combination with zimberelimab and carboplatin/pemetrexed once every 3 weeks, for up to 2 years
Arm Title
Dose Expansion Cohort 2 Gastric/GEJ Cancer
Arm Type
Experimental
Arm Description
Participants will receive AB598 IV infusion in combination with zimberelimab once every 3 weeks, and FOLFOX (oxaliplatin, leucovorin, fluorouracil) every 2 weeks, for up to 2 years
Intervention Type
Drug
Intervention Name(s)
AB598
Intervention Description
Administered as specified in the treatment arm
Intervention Type
Drug
Intervention Name(s)
Zimberelimab
Other Intervention Name(s)
AB122
Intervention Description
Administered as specified in the treatment arm
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Administered as specified in the treatment arm
Intervention Type
Drug
Intervention Name(s)
Pemetrexed
Intervention Description
Administered as specified in the treatment arm
Intervention Type
Drug
Intervention Name(s)
Fluorouracil
Intervention Description
Administered as specified in the treatment arm
Intervention Type
Drug
Intervention Name(s)
Leucovorin
Intervention Description
Administered as specified in the treatment arm
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Description
Administered as specified in the treatment arm
Primary Outcome Measure Information:
Title
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame
Up to 2 years
Title
Dose Escalation Cohorts: Number of Participants with Dose-Limiting Toxicities (DLTs)
Time Frame
Up to 2 years
Secondary Outcome Measure Information:
Title
Area Under the Concentration-Time Curve from Administration ("0") to the Time That the Drug is No Longer Present in the Body ("infinity") (AUC 0-inf) in Whole Blood and Plasma
Time Frame
Predose, Up to 4 hours postdose
Title
Maximum Concentration (Cmax) in Whole Blood and Plasma
Time Frame
Predose, Up to 4 hours postdose
Title
Time to Maximum Concentration (Tmax) in Whole Blood and Plasma
Time Frame
Predose, Up to 4 hours postdose
Title
Number of Participants Who Test Positive for Antidrug Antibodies (ADAs) to AB598
Time Frame
Up to 2 years
Title
Objective Response Rate (ORR)
Time Frame
Up to 2 years
Title
Dose Expansion Cohorts: Duration of Response (DOR)
Time Frame
Up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) guidance Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 Monotherapy-specific criteria for dose escalation cohorts: Participants may have pathologically confirmed NSCLC, gastric/GEJ, esophageal, HNSCC, bladder, RCC, TNBC, cervical, and ovarian cancers for which standard therapy has proven ineffective, intolerable, or considered inappropriate Disease-specific criteria for dose-expansion Cohort 1 (NSCLC): Histologically confirmed, documented diagnosis of locally advanced unresectable or metastatic non-squamous NSCLC Treatment-naive in the unresectable locally advanced or metastatic setting Cannot have progressed within 6 months of prior platinum-based chemotherapy Mixed small-cell lung cancer histology is not permitted Disease-specific criteria for dose expansion Cohort 2 (Gastric/GEJ): Histologically confirmed, documented diagnosis of human epidermal growth factor 2 (HER2)-negative locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma No prior systemic treatment for locally advanced unresectable or metastatic disease Cannot have progressed within 6 months of prior platinum-based chemotherapy Key Exclusion Criteria: Use of any live vaccines against infectious diseases (eg, influenza, varicella) within 4 weeks (28 days) of initiation of study Underlying medical conditions or AEs that, in the investigator's or sponsor's opinion, will make the administration of the study drugs hazardous Any active or documented history of autoimmune disease including but not limited to inflammatory bowel disease, celiac disease, Wegner syndrome, Hashimoto syndrome, systemic lupus erythematosus, scleroderma, sarcoidosis, or autoimmune hepatitis, within 3 years of the first dose of study treatment History of trauma or major surgery within 28 days prior to the first dose of study drug Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressant medication during study treatment with certain protocol specified exceptions Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Medical Director
Phone
+1-510-462-3330
Email
ClinicalTrials@arcusbio.com
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
Affinity Health-Hope and Healing Cancer Services, LLC
City
Hinsdale
State/Province
Illinois
ZIP/Postal Code
60521
Country
United States
Individual Site Status
Recruiting
Facility Name
Gabrail Cancer Center
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Individual Site Status
Recruiting
Facility Name
Next Oncology Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75039
Country
United States
Individual Site Status
Recruiting

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

Study of AB598 Monotherapy and Combination Therapy in Participants With Advanced Cancers

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