At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Calderasib (drug), Oxaliplatin (drug), Leucovorin/levofolinate calcium (drug), 5-Fluorouracil (drug)
- How long the study runs
- Study runs about 63 months (dates as stated)
- About the drug or intervention
- Calderasib — drug: Oral tablet · Oxaliplatin — drug: Per label · Leucovorin/levofolinate calcium — drug: Per label · 5-Fluorouracil — drug: Per label · Cetuximab — biological: Per label · Bevacizumab — drug: Per label · Bevacizumab biosimilar — drug: Per label
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 477
- Started
- 2025-07-16
- Last checked
- 2026-10
Plain English Summary
What is this study?
- • Testing a new treatment for colon adenocarcinoma
- • Phase3 - 477 participants
- • Researchers are looking for other ways to treat locally advanced or metastatic colorectal cancer (mCRC) that is unresectable and has a gene mutation called KRAS G12C
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with colon adenocarcinoma
Where?
- • Birmingham - Heartlands Hospital ( Site 1759)
- • London - University College London Hospitals ( Site 1750)
- • Oxford - Churchill Hospital ( Site 1756)
- • Coventry - University Hospital Coventry & Warwickshire ( Site 1761)
- • +2 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
Researchers are looking for other ways to treat locally advanced or metastatic colorectal cancer (mCRC) that is unresectable and has a gene mutation called KRAS G12C. Standard (or usual) treatments for this type of colorectal cancer may include mFOLFOX6 with or without bevacizumab. Researchers want to learn if adding calderasib (the study medicine) and cetuximab to mFOLFOX6 can treat locally advanced or mCRC with the KRAS G12C mutation. Calderasib and cetuximab are targeted therapies. The goals of this study are to learn: * About the safety of calderasib with cetuximab and mFOLFOX6 and if people tolerate the treatments * If people who receive calderasib with cetuximab and mFOLFOX6 live longer without mCRC growing or spreading compared to people who receive mFOLFOX6 with or without bevacizumab.
More detail
This study will have 2 parts.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ well controlled HIV on antiretroviral therapy (ART)
What the study is looking for
- ✓The main inclusion criteria include but are not limited to the following:
- ✓Demonstrates presence of a Kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation
- ✓Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
- ✓Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B...
- ✓Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable
Who cannot take part
- ✗The main exclusion criteria include but are not limited to the following:
- ✗Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of...
- ✗Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
- ✗Has known partial or complete dihydropyrimidine dehydrogenase (DPD) deficiency
- ✗HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
See the full criteria
Where Is This Study? (6 UK sites)
Heartlands Hospital ( Site 1759)
Birmingham B9 5ss, United Kingdom
University College London Hospitals ( Site 1750)
London NW1 2PG, United Kingdom
Churchill Hospital ( Site 1756)
Oxford ox3 7le, United Kingdom
University Hospital Coventry & Warwickshire ( Site 1761)
Coventry CV2 2DX, United Kingdom
Velindre Cancer Centre Hospital ( Site 1753)
Cardiff CF14 2TL, United Kingdom
The Christie NHS Foundation Trust ( Site 1755)
Manchester M20 4BX, United Kingdom
How to Get in Touch
Toll Free Number
Sponsor contactCONTACT
