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Monoclonal Antibodies
AB308 + Zimberelimab for Advanced Cancers (ARC-12 Trial)
Phase 1
Waitlist Available
Research Sponsored by Arcus Biosciences, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from study enrollment until disease progression or loss of clinical benefit (up to approximately 3-5 years)
Awards & highlights
ARC-12 Trial Summary
This trial is testing a new combination therapy to see if it is safe and effective in treating advanced malignancies.
Who is the study for?
This trial is for adults with advanced malignancies like certain lymphomas, lung, stomach, esophageal cancers and more. Participants must be able to consent, have an ECOG score of 0 or 1 indicating they are fully active or restricted in physically strenuous activity but ambulatory, and have proper organ/marrow function. They should not have had severe reactions to past immunotherapies or recent surgeries and must agree to use contraception.Check my eligibility
What is being tested?
The study tests AB308 combined with Zimberelimab (AB122) on patients with advanced cancers. It's a Phase 1/1b trial that gradually increases doses to assess safety, how the body processes the drugs (PK), their effects on the body (PD), and their effectiveness against tumors.See study design
What are the potential side effects?
While specific side effects aren't listed here, typical ones for cancer treatments like these may include fatigue, nausea, immune-related reactions such as inflammation in different parts of the body including skin rashes or liver issues; infusion-related reactions; changes in blood counts leading to increased infection risk.
ARC-12 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or restricted in physically strenuous activity but can do light work.
ARC-12 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from study enrollment until disease progression or loss of clinical benefit (up to approximately 3-5 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from study enrollment until disease progression or loss of clinical benefit (up to approximately 3-5 years)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of participants who experience a Dose Limiting Toxicity
Percentage of participants with Adverse Events
Secondary outcome measures
Duration of Response
Percentage of Participants with Disease Control (complete response, partial response, or stable disease) for >6 months
Percentage of participants with Objective Response
+4 moreARC-12 Trial Design
8Treatment groups
Experimental Treatment
Group I: Dose Expansion Cohort 5Experimental Treatment2 Interventions
AB308 will be given in combination with zimberelimab at 360 mg or 480 mg Q3W or Q4W, respectively, in participants with hematological malignancies.
Group II: Dose Expansion Cohort 4Experimental Treatment2 Interventions
AB308 will be given in combination with zimberelimab at 360 mg or 480 mg Q3W or Q4W, respectively, in participants with cervical cancer.
Group III: Dose Expansion Cohort 3Experimental Treatment2 Interventions
AB308 will be given in combination with zimberelimab at 360 mg or 480 mg Q3W or Q4W, respectively, in participants with metastatic gastric, or gastroesophageal junction, or esophageal cancer.
Group IV: Dose Expansion Cohort 2Experimental Treatment2 Interventions
AB308 will be given in combination with zimberelimab at 360 mg or 480 mg Q3W or Q4W, respectively, in participants with melanoma.
Group V: Dose Expansion Cohort 1Experimental Treatment2 Interventions
AB308 will be given in combination with zimberelimab at 360 mg or 480 mg Q3W or Q4W, respectively, in participants with in participants with locally advanced or metastatic NSCLC.
Group VI: Dose Escalation Q6W CohortExperimental Treatment2 Interventions
Selected dose of AB308 in combination with zimberelimab will be given every 6 weeks in participants with advanced malignancies.
Group VII: Dose Escalation Q4W CohortsExperimental Treatment2 Interventions
Escalating doses of AB308 in combination with zimberelimab (480 mg) will be given every 4 weeks in participants with advanced malignancies.
Group VIII: Dose Escalation Q3W CohortsExperimental Treatment2 Interventions
Escalating doses of AB308 in combination with zimberelimab (360 mg) will be given every 3 weeks in participants with advanced malignancies.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Zimberelimab
2018
Completed Phase 1
~50
Find a Location
Who is running the clinical trial?
Arcus Biosciences, Inc.Lead Sponsor
41 Previous Clinical Trials
5,972 Total Patients Enrolled
Gilead SciencesIndustry Sponsor
1,084 Previous Clinical Trials
848,168 Total Patients Enrolled
Medical DirectorStudy DirectorArcus Biosciences
2,782 Previous Clinical Trials
8,066,222 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My organs and bone marrow are working well.I can sign and follow the study's consent form and rules.I am 18 years or older and can legally consent to participate.I have not needed treatment for an autoimmune disease in the last 3 years.I am fully active or restricted in physically strenuous activity but can do light work.I stopped immunotherapy due to severe side effects.I have not had major surgery or serious injury in the last 28 days.I have been treated with an anti-TIGIT antibody before.I haven't taken any cancer drugs or been in a drug study in the last 28 days.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Expansion Cohort 3
- Group 2: Dose Expansion Cohort 4
- Group 3: Dose Expansion Cohort 5
- Group 4: Dose Escalation Q3W Cohorts
- Group 5: Dose Escalation Q4W Cohorts
- Group 6: Dose Escalation Q6W Cohort
- Group 7: Dose Expansion Cohort 1
- Group 8: Dose Expansion Cohort 2
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 openings still available for participants of this investigation?
"According to clinicaltrials.gov, this research project remains open for patient recruitment. The trial was first listed on March 19th 2021 and has since undergone multiple revisions up until November 21st 2022."
Answered by AI
Are there known health risks associated with AB308 ingestion?
"Due to the limited data surrounding AB308's safety and efficacy, we at Power deemed it a 1 on our risk scale."
Answered by AI
In what locations can one access this research?
"Patients are being recruited for this trial at multiple sites, including AdventHealth Orlando in Aurora, Colorado; University of Colorado - Cancer Center - PPDS in Phoenix, Arizona; and Mayo Clinic Arizona - Mayo Clinic Hospital in Augusta, Georgia. In total there are 30 facilities taking part."
Answered by AI
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