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AB598 + Chemotherapy for Advanced Cancers (ARC-25 Trial)
Phase 1
Recruiting
Research Sponsored by Arcus Biosciences, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
ARC-25 Trial Summary
This trial tests a new drug to see if it's safe and works with chemotherapy to treat advanced cancer.
Who is the study for?
This trial is for adults with certain advanced cancers, including stomach, lung, and breast cancer. Participants must have a specific performance status score and at least one measurable lesion. They should not have received prior treatment for their advanced cancer or progressed within 6 months after platinum-based chemotherapy.Check my eligibility
What is being tested?
The study tests the safety of AB598 alone and combined with zimberelimab plus standard chemo drugs like Pemetrexed and Oxaliplatin in patients with advanced malignancies. It aims to find out how well these treatments are tolerated by participants.See study design
What are the potential side effects?
Possible side effects may include typical reactions to immunotherapy such as fatigue, skin reactions, digestive issues, potential immune-related complications affecting various organs, as well as those associated with chemotherapy like nausea and low blood cell counts.
ARC-25 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose Escalation Cohorts: Number of Participants with Dose-Limiting Toxicities (DLTs)
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
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
Dose Expansion Cohorts: Duration of Response (DOR)
Maximum Concentration (Cmax) in Whole Blood and Plasma
+3 moreARC-25 Trial Design
6Treatment groups
Experimental Treatment
Group I: Dose Expansion Cohort 2 Gastric/GEJ CancerExperimental Treatment5 Interventions
Participants will receive AB598 IV infusion every 2 weeks in combination with zimberelimab once every 4 weeks, and FOLFOX (oxaliplatin, leucovorin, fluorouracil) every 2 weeks, for up to 2 years
Group II: Dose Expansion Cohort 1 NSCLCExperimental Treatment4 Interventions
Participants will receive AB598 IV infusion in combination with zimberelimab and carboplatin/pemetrexed once every 3 weeks, for up to 2 years
Group III: Dose Escalation Cohort 4Experimental Treatment1 Intervention
Participants will receive AB598 IV infusion once every 3 weeks
Group IV: Dose Escalation Cohort 3Experimental Treatment1 Intervention
Participants will receive AB598 IV infusion once every 3 weeks
Group V: Dose Escalation Cohort 2Experimental Treatment1 Intervention
Participants will receive AB598 IV infusion once every 3 weeks
Group VI: Dose Escalation Cohort 1Experimental Treatment1 Intervention
Participants will receive AB598 intravenous (IV) infusion once every 3 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pemetrexed
2014
Completed Phase 3
~5250
Fluorouracil
2014
Completed Phase 3
~11540
Leucovorin
2005
Completed Phase 4
~5730
Oxaliplatin
2011
Completed Phase 4
~2560
Zimberelimab
2018
Completed Phase 1
~50
Carboplatin
2014
Completed Phase 3
~6670
Find a Location
Who is running the clinical trial?
Arcus Biosciences, Inc.Lead Sponsor
41 Previous Clinical Trials
5,985 Total Patients Enrolled
Medical DirectorStudy DirectorArcus Biosciences
2,777 Previous Clinical Trials
8,064,138 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer did not worsen within 6 months after receiving platinum-based chemotherapy.My lung cancer is not mixed with small-cell type.I have not had major surgery or serious injury in the last 28 days.I haven't taken immunosuppressive drugs in the last 2 weeks and don't expect to need them during the study.I haven't had an autoimmune disease in the last 3 years.I don't have health issues that make study drugs risky for me.I have not received any live vaccines in the last 4 weeks.I am fully active or restricted in physically strenuous activity but can do light work.I haven't had systemic treatment for my advanced cancer that can't be surgically removed.My cancer did not worsen within 6 months after platinum-based chemotherapy.My lung cancer is advanced, cannot be surgically removed, and is not squamous type.I have not received any treatment for my advanced or metastatic cancer.My cancer is HER2-negative and has spread beyond where it started in my stomach or gastroesophageal junction.My cancer has spread, and standard treatments haven't worked or aren't suitable for me.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Escalation Cohort 2
- Group 2: Dose Escalation Cohort 1
- Group 3: Dose Expansion Cohort 1 NSCLC
- Group 4: Dose Escalation Cohort 3
- Group 5: Dose Expansion Cohort 2 Gastric/GEJ Cancer
- Group 6: Dose Escalation Cohort 4
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any openings left for enrolment in this investigation?
"The clinical trial, which was first posted in August 1st 2023 and last updated two days later, is actively looking for participants. All details about the study are available on clinicaltrials.gov."
Answered by AI
How many participants has the research team accepted for this trial?
"Indeed, the clinical trial is actively enrolling. The initial post was published on August 1st 2023 and updated most recently on August 2nd 2023. 81 participants need to be recruited for this study at a single site."
Answered by AI
Has the Dose Escalation Cohort 2 undergone FDA evaluation?
"Our team has ranked the safety of Dose Escalation Cohort 2 as a 1 due to limited evidence regarding its efficacy and safety, which is typical for Phase 1 trials."
Answered by AI
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