Advanced CancerPhase 1ARC-25NCT05891171
Study of AB598 Monotherapy and Combination Therapy in Participants With Advanced Cancers
A Phase 1 study testing AB598, Zimberelimab and Fluorouracil in people with Advanced Cancer and Advanced Malignancies, run by Arcus Biosciences, Inc. at 14 sites in 3 countries.
Trial summary
The primary purpose of this study is to assess the safety and tolerability of AB598 in participants with advanced malignancies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer, Advanced Malignancies, Bladder Cancer
- What is being tested?
- AB598, Zimberelimab and Fluorouracil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 14 sitesin 3 countries
- Study dates
- 13 Oct 2023to Sep 2027
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
14 sites in 3 countries.
14 sites in 3 countries
United States11 sites
Research Site
Canton, Ohio, 44718
Research Site
Cleveland, Ohio, 44106
Research Site
Detroit, Michigan, 48201
Research Site
Fairfax, Virginia, 22031
Research Site
Hinsdale, Illinois, 60521
Research Site
Irving, Texas, 75039
Research Site
Jacksonville, Florida, 32224
Research Site
Lake City, Florida, 32024
Research Site
New Brunswick, New Jersey, 08901
Research Site
Phoenix, Arizona, 85054
Research Site
Rochester, Minnesota, 55905
About this study
Official title: A Phase 1/1b Study to Evaluate the Safety and Tolerability of AB598 Monotherapy and Combination Therapy in Participants With Advanced Malignancies
The primary purpose of this study is to assess the safety and tolerability of AB598 in participants with advanced malignancies.
- Conditions
- Advanced Cancer, Advanced Malignancies, Bladder Cancer, Cervical Cancer, Esophageal Cancer, Gastric Cancer
- Being tested
- AB598, Zimberelimab, Fluorouracil, Leucovorin, Oxaliplatin
- Keywords
- AB598, AB122, Zimberelimab
- Medical subject headings
- Urinary Bladder Neoplasms, Uterine Cervical Neoplasms, Esophageal Neoplasms, Stomach Neoplasms, Squamous Cell Carcinoma of Head and Neck, Carcinoma, Non-Small-Cell Lung, Ovarian Neoplasms, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AB598Drug
Administered as specified in the treatment arm
ZimberelimabDrug
Also called AB122
Administered as specified in the treatment arm
FluorouracilDrug
Administered as specified in the treatment arm
LeucovorinDrug
Administered as specified in the treatment arm
OxaliplatinDrug
Administered as specified in the treatment arm
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation Cohort 1 | Experimental | Participants will receive AB598 intravenous (IV) infusion once every 3 weeks Receives: Drug: AB598 |
| Dose Escalation Cohort 2 | Experimental | Participants will receive AB598 IV infusion once every 3 weeks Receives: Drug: AB598 |
| Dose Escalation Cohort 3 | Experimental | Participants will receive AB598 IV infusion once every 3 weeks Receives: Drug: AB598 |
| Dose Escalation Cohort 4 | Experimental | Participants will receive AB598 IV infusion once every 3 weeks Receives: Drug: AB598 |
| Pharmacodynamic Cohort 1 | Experimental | Participants will receive AB598 IV infusion once every 3 weeks Receives: Drug: AB598 |
| Pharmacodynamic Cohort 2 | Experimental | Participants will receive AB598 IV infusion once every 3 weeks Receives: Drug: AB598 |
| Pharmacodynamic Cohort 3 | Experimental | Participants will receive AB598 IV infusion once every 3 weeks Receives: Drug: AB598 |
| Dose Expansion Gastric/GEJ Cancer (phase 1b) | Experimental | Participants will receive AB598 IV infusion every 2 weeks in combination with zimberelimab and FOLFOX (oxaliplatin, leucovorin, fluorouracil) Receives: Drug: AB598; Drug: Zimberelimab; Drug: Fluorouracil; Drug: Leucovorin; Drug: Oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: Up to 2 years
Dose Escalation Cohorts: Number of Participants with Dose-Limiting Toxicities (DLTs)
Measured: 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
Measured: Predose, Up to 4 hours post dose
Maximum Concentration (Cmax) in Whole Blood and Plasma
Measured: Predose, Up to 4 hours post dose
Time to Maximum Concentration (Tmax) in Whole Blood and Plasma
Measured: Predose, Up to 4 hours post dose
Number of Participants Who Test Positive for Antidrug Antibodies (ADAs) to AB598
Measured: Up to 2 years
Objective Response Rate (ORR)
Measured: Up to 2 years
Dose Expansion Cohort: Duration of Response (DOR)
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2023
- Study start13 Oct 2023
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arcus Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Arcus Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05891171
- Sponsor's protocol ID
- ARC-25
- Acronym
- ARC-25
- Status last verified
- Apr 2026
- First submitted
- 26 May 2023
- Last updated
- 29 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.