Study of AB598 Monotherapy and Combination Therapy in Participants With Advanced Cancers
ARC-25
A Phase 1/1b Study to Evaluate the Safety and Tolerability of AB598 Monotherapy and Combination Therapy in Participants With Advanced Malignancies
1 other identifier
interventional
40
3 countries
14
Brief Summary
The primary purpose of this study is to assess the safety and tolerability of AB598 in participants with advanced malignancies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Oct 2023
Longer than P75 for phase_1
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 26, 2023
CompletedFirst Posted
Study publicly available on registry
June 6, 2023
CompletedStudy Start
First participant enrolled
October 13, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2027
July 30, 2026
April 1, 2026
3.9 years
May 26, 2023
July 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Up to 2 years
Dose Escalation Cohorts: Number of Participants with Dose-Limiting Toxicities (DLTs)
Up to 2 years
Secondary Outcomes (6)
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
Predose, Up to 4 hours post dose
Maximum Concentration (Cmax) in Whole Blood and Plasma
Predose, Up to 4 hours post dose
Time to Maximum Concentration (Tmax) in Whole Blood and Plasma
Predose, Up to 4 hours post dose
Number of Participants Who Test Positive for Antidrug Antibodies (ADAs) to AB598
Up to 2 years
Objective Response Rate (ORR)
Up to 2 years
- +1 more secondary outcomes
Study Arms (8)
Dose Escalation Cohort 1
EXPERIMENTALParticipants will receive AB598 intravenous (IV) infusion once every 3 weeks
Dose Escalation Cohort 2
EXPERIMENTALParticipants will receive AB598 IV infusion once every 3 weeks
Dose Escalation Cohort 3
EXPERIMENTALParticipants will receive AB598 IV infusion once every 3 weeks
Dose Escalation Cohort 4
EXPERIMENTALParticipants will receive AB598 IV infusion once every 3 weeks
Pharmacodynamic Cohort 1
EXPERIMENTALParticipants will receive AB598 IV infusion once every 3 weeks
Pharmacodynamic Cohort 2
EXPERIMENTALParticipants will receive AB598 IV infusion once every 3 weeks
Pharmacodynamic Cohort 3
EXPERIMENTALParticipants will receive AB598 IV infusion once every 3 weeks
Dose Expansion Gastric/GEJ Cancer (phase 1b)
EXPERIMENTALParticipants will receive AB598 IV infusion every 2 weeks in combination with zimberelimab and FOLFOX (oxaliplatin, leucovorin, fluorouracil)
Interventions
Administered as specified in the treatment arm
Administered as specified in the treatment arm
Administered as specified in the treatment arm
Administered as specified in the treatment arm
Administered as specified in the treatment arm
Eligibility Criteria
You may qualify if:
- 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
- Prior systemic radiation or whole brain radiation therapy must have been completed at least 4 weeks before investigational product (IP) administration. Other palliative radiotherapy must be completed 2 weeks before investigational product administration, if radiation therapy-related AEs have resolved to Grade ≤ 1.
- Monotherapy-specific criteria for dose escalation and PD cohorts:
- Dose Escalation: Participants may have any pathologically confirmed advanced or metastatic solid tumor for which standard therapy has proven ineffective, intolerable, or is considered inappropriate.
- Pharmacodynamic Cohorts: Participants may have any pathologically confirmed advanced or metastatic solid tumors for which standard therapy has proven ineffective, intolerable, or is considered inappropriate. Participants must be able to undergo collection of a fresh frozen biopsy during screening, as well as provide an on-treatment fresh frozen biopsy.
- Dose Expansion cohort criteria:
- Histologically confirmed, documented diagnosis of 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 for earlier stage disease.
You may not qualify if:
- 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 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Research Site
Phoenix, Arizona, 85054, United States
Research Site
Jacksonville, Florida, 32224, United States
Research Site
Lake City, Florida, 32024, United States
Research Site
Hinsdale, Illinois, 60521, United States
Research Site
Detroit, Michigan, 48201, United States
Research Site
Rochester, Minnesota, 55905, United States
Research Site
New Brunswick, New Jersey, 08901, United States
Research Site
Canton, Ohio, 44718, United States
Research Site
Cleveland, Ohio, 44106, United States
Research Site
Irving, Texas, 75039, United States
Research Site
Fairfax, Virginia, 22031, United States
Research Site
Adelaide, Australia
Research Site
Tainan, Taiwan
Research Site
Taipei, Taiwan
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Arcus Biosciences
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 26, 2023
First Posted
June 6, 2023
Study Start
October 13, 2023
Primary Completion (Estimated)
September 1, 2027
Study Completion (Estimated)
September 1, 2027
Last Updated
July 30, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
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.