Recruiting nowPhase 2Randomised
| Registry number | NCT07659795 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 2 |
| Design | randomised, blinded |
| Taking part | 150 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | Verastem, Inc. |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug VS-7375
- Drug cetuximab
- Drug panitumumab
- Drug Cetuximab + mFOLFOX6
What it is measuring
Confirmed ORR by blinded independent central review (BICR) per RESIST v1.1 – 2L CRC only
This is the trial's main question — the one it is designed and sized to answer. Anything else it reports is a secondary finding, and secondary findings are far more likely to be chance.
What this trial is trying to do
VS-7375 is designed to block signalling from the KRAS G12D mutation, which can drive colorectal-cancer growth. The trial asks whether VS-7375 alone, or combined with an EGFR-blocking antibody such as cetuximab or panitumumab—with one combination also including chemotherapy—can control metastatic cancer better than the comparison treatments.
The researchers are testing whether targeting KRAS G12D directly, alone or alongside existing treatment, leads to more tumour shrinkage than the trial’s other treatment arms. The main measure is the confirmed objective response rate (the proportion of tumours that shrink), specifically in people receiving second-line treatment, rather than how long patients live.
Worth knowing: This is a phase 2 trial, and its main endpoint is tumour response rather than survival or the length of time before the cancer grows.
Written from the trial's own registry entry to explain what the researchers are testing and why. Nothing here is a result — this trial has not reported one — and it is not a view on whether the treatment works or on whether it would suit you.
Phase 2. Tests whether the treatment works well enough to be worth a larger trial. Usually too small to prove it changes survival.
How the researchers describe it
This study will assess the safety and efficacy of VS-7375 alone and in combination with cetuximab or panitumumab and cetuximab plus mFOLFOX in patients with metastatic KRAS G12D – mutated Colorectal Cancer
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- RAS mutated
- G12D
- Metastatic
- Already treated
Read automatically from the criteria below, to make the list searchable. It is a summary of what the text mentions, not a decision about whether you qualify — and where the two disagree, the criteria are right and this is wrong.
Who the trial is looking for
Inclusion Criteria
- Histopathology confirmed metastatic CRC
- Measurable disease per RECIST 1.1
- Local testing confirmed KRAS G12D mutation (tissue required for confirmatory central testing)
- ECOG PS=0 or 1
2L+ patients:
- Must have received at least 1 standard chemotherapy for metastatic colorectal adenocarcinoma
- Have documented disease progression during or following their most recent prior line of therapy
- Have either stable disease, partial response (PR), or complete response (CR) by RECIST v1.1 as the best overall response (BOR) during at least 1 prior systemic therapy.
1L patients:
- Treatment-naïve or received no more than 1 cycle of standard systemic therapy for metastatic disease.
Exclusion Criteria
- Have any other documented co-existing common RAS mutation(s)
- Prior anti-cancer Tx within 4 weeks or drug-specific timeline within first treatment dose, whichever shorter
- Major surgery within 4 weeks of first treatment dose
- Radiation therapy (RT) within 1 week of first treatment dose
- Receipt of prior direct RAS inhibitor
- Receipt of more than 1 investigational therapy
- Untreated or symptomatic CNS metastasis
- Receipt of strong CYP3A4 inhibitor/inducer or CYP3A4 sensitive substrates with narrow therapeutic index within 14 days or drug-specific timeline within first treatment dose, whichever is shorter
- Receipt of PPI or H2 blocker within 5 days
- …
This is an extract. Whether you qualify is decided by the trial team against the full criteria, not by reading this page. Read the full eligibility criteria
Where it is running
Running at 10 sites. Listed in: Australia, United States.
Individual hospitals, and whether each is currently open, are listed on the registry record. Sites open and close throughout a trial.
Worth asking your oncology team
Being listed here is not a recommendation, and no one page can tell you whether a trial is right for you. These are the questions it raises.
- Is this trial open at a hospital I could realistically travel to?
- Given my stage, my previous treatment and my tumour's molecular profile, would I be eligible?
- What would I be giving up by joining — is the comparison arm the treatment I would otherwise be having?
- What is already known about the safety of what is being tested?
The source
Registry record NCT07659795, registered by Verastem, Inc. on ClinicalTrials.gov, a public database run by the US National Library of Medicine. The details on this page come from that record and are only ever as current as the sponsor has kept it.
This is a listing of a registered clinical trial, reproduced for information. It is not a recommendation, this site has no connection to the trial or its sponsor, and being listed here says nothing about whether the treatment works. Talk to your own oncology team before pursuing any trial.
This article summarises published research for general information. It is not medical advice, and it is not a substitute for a conversation with your own oncology team, who know your case. Do not start, stop, or change any treatment or supplement on the basis of what you read here.