Your session is about to expire
← Back to Search
Unknown
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 5 years
Awards & highlights
No Placebo-Only Group
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.
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.
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
8Treatment groups
Experimental Treatment
Group I: Pharmacodynamic Cohort 3Experimental Treatment1 Intervention
Participants will receive AB598 IV infusion once every 3 weeks
Group II: Pharmacodynamic Cohort 2Experimental Treatment1 Intervention
Participants will receive AB598 IV infusion once every 3 weeks
Group III: Pharmacodynamic Cohort 1Experimental Treatment1 Intervention
Participants will receive AB598 IV infusion once every 3 weeks
Group IV: Dose Expansion Gastric/GEJ Cancer (phase 1b)Experimental Treatment5 Interventions
Participants will receive AB598 IV infusion every 2 weeks in combination with zimberelimab and FOLFOX (oxaliplatin, leucovorin, fluorouracil)
Group V: Dose Escalation Cohort 4Experimental Treatment1 Intervention
Participants will receive AB598 IV infusion once every 3 weeks
Group VI: Dose Escalation Cohort 3Experimental Treatment1 Intervention
Participants will receive AB598 IV infusion once every 3 weeks
Group VII: Dose Escalation Cohort 2Experimental Treatment1 Intervention
Participants will receive AB598 IV infusion once every 3 weeks
Group VIII: 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
Leucovorin
2005
Completed Phase 4
~6010
Fluorouracil
2014
Completed Phase 3
~11700
Oxaliplatin
2011
Completed Phase 4
~2890
Zimberelimab
2019
Completed Phase 2
~300
Find a Location
Who is running the clinical trial?
Arcus Biosciences, Inc.Lead Sponsor
43 Previous Clinical Trials
7,105 Total Patients Enrolled
Medical DirectorStudy DirectorArcus Biosciences
2,905 Previous Clinical Trials
8,091,402 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: Pharmacodynamic Cohort 1
- Group 2: Pharmacodynamic Cohort 2
- Group 3: Pharmacodynamic Cohort 3
- Group 4: Dose Expansion Gastric/GEJ Cancer (phase 1b)
- Group 5: Dose Escalation Cohort 1
- Group 6: Dose Escalation Cohort 2
- Group 7: Dose Escalation Cohort 3
- Group 8: 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.