ARC9 Efficacy & Safety of AB928 based tx combinations in pts with mCRC
Research type
Research Study
Full title
A Phase 1b/2, Open-Label, Randomized Platform Study Evaluating the Efficacy and Safety of AB928-Based Treatment Combinations in Patients with Metastatic Colorectal Cancer
IRAS ID
292180
Contact name
David Cunningham
Contact email
Sponsor organisation
Arcus Biosciences, Inc.
Eudract number
2020-005386-13
Clinicaltrials.gov Identifier
IND Number, 139447
Duration of Study in the UK
2 years, 3 months, 8 days
Research summary
This is a Phase 1b/2, open-label (participants and investigators will know what treatment group a participant has been assigned to), multicentre trial to evaluate etruma-based combination therapy in participants with colorectal cancer(mCRC) that has spread from its original location.
After an initial single Safety Run-in treatment group or 'cohort', treatment cohorts will independently evaluate etruma plus zimerelimab in combination with a standard of care (SOC) treatment (mFOLFOX-6 + bevacizumab) or with a new treatment. There will be 3 treatment cohorts plus the safety cohort.
Bevacizumab treatment cohorts will include the use of bevacizumab for all participants unless there is a medical reason they should not receive it. Participant eligibility for a specific cohort will be based on prior anti-cancer treatment history.
Treatment cohort C is designed to explore additional study treatment plans as new therapies become available, to stop a build up of participants into existing treatment plans that demonstrate minimal clinical improvement or unacceptable toxicity.
Eligible participants will be assigned to one of the following groups based on their prior cancer treatments:
• Etruma + Zimberelimab + mFOLFOX-6+/-Bevacizumab( Bev) (Group A and safety cohort)
• mFOLFOX-6 +/- Bev (Group A)
• Etruma + Zimberelimab + mFOLFOX-6+/-Bev (Group B)
• Regorafenib (Group B)
• Etruma + Zimberelimab + AB680 (Group C)
• Etruma + Zimberelimab + Agent X (Group C). Agent X is a new investigational treatment that may be identified during the course of the study.The planned number of participants in each group is as follows:
Safety Run-in group – 6 to 12 participants
Cohort A (2L) – approximately 90 participants
Cohort B (3L) – approximately 105 participants
Cohort C (>3L) – approximately 15 participants in Stage 1 and up to 25 participants in Stage 2.Study procedures for all cohorts will include physical examinations, blood samples, ECGs, tumour biopsies and CT or MRI scans.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
21/SC/0138
Date of REC Opinion
8 Sep 2021
REC opinion
Further Information Favourable Opinion