VS-7375 + Cetuximab for Pancreatic Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial investigates a new treatment called VS-7375, both alone and combined with cetuximab, to determine its safety and effectiveness for individuals with metastatic pancreatic cancer and a specific KRAS G12D mutation. The trial seeks to evaluate the efficacy of these treatments both individually and in combination. Suitable participants have a diagnosis of pancreatic cancer, possess the KRAS G12D mutation, and have received either no or limited prior treatment for their metastatic cancer. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.
Do I need to stop my current medications for the trial?
The trial requires stopping certain medications before starting, such as strong CYP3A4 inhibitors/inducers and PPIs or H2 blockers. It's best to discuss your current medications with the trial team to see if any need to be paused.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Previous studies have shown that VS-7375 is safe. Participants generally tolerated doses of 400 mg and 600 mg well, with no serious side effects preventing dose escalation. When combined with cetuximab, the treatment was also well-tolerated in individuals with advanced solid tumors. The available data report no severe safety issues, suggesting that both VS-7375 alone and with cetuximab are safe for further testing in humans.12345
Why are researchers excited about this trial's treatments?
Unlike the standard treatments for pancreatic cancer, like chemotherapy and radiation, VS-7375 is making waves because it targets specific cancer pathways potentially leading to more precise cancer cell destruction. Researchers are especially excited about combining VS-7375 with cetuximab, an antibody that blocks growth signals in cancer cells, which could enhance treatment effectiveness. This combination therapy might offer a new hope for patients by potentially improving outcomes and reducing side effects compared to traditional therapies.
What evidence suggests that this trial's treatments could be effective for metastatic KRAS G12D-mutated pancreatic cancer?
Research has shown that the drug VS-7375 may help treat pancreatic cancer with a specific mutation called KRAS G12D. In an earlier study, 80% of patients experienced tumor shrinkage when using VS-7375 alone. In this trial, some participants will receive VS-7375 as monotherapy. Another study found that more than half of the patients (52%) had their tumors shrink or stop growing. In this trial, other participants will receive VS-7375 combined with cetuximab. When used with cetuximab, 41% of heavily pre-treated patients saw their tumors shrink or disappear. These results suggest that VS-7375, alone or with cetuximab, could effectively manage this type of pancreatic cancer.24678
Are You a Good Fit for This Trial?
This trial is for adults with pancreatic cancer that has spread and has a specific KRAS G12D mutation. Participants must have good organ function, be generally well (able to carry out daily activities), and have had no more than one prior treatment for metastatic disease.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive VS-7375 alone or in combination with cetuximab for metastatic KRAS G12D-mutated pancreatic cancer
Follow-up
Participants are monitored for safety and effectiveness after treatment
Pharmacokinetics and Pharmacodynamics Assessment
Assessment of plasma pharmacokinetics and pharmacodynamics of VS-7375
What Are the Treatments Tested in This Trial?
Interventions
- cetuximab
- VS-7375
Trial Overview
The study is testing the safety and effectiveness of a new drug called VS-7375, given alone or together with another drug called cetuximab, in people with advanced KRAS G12D-mutated pancreatic cancer.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Verastem, Inc.
Lead Sponsor
Citations
1.
investor.verastem.com
investor.verastem.com/news-releases/news-release-details/verastem-oncology-announces-encouraging-preliminary-data-ongoingPress Release
Of the five efficacy evaluable patients in the VS-7375-101 study with at least one scan, four out of five patients have had a tumor reduction ...
2.
aacrjournals.org
aacrjournals.org/mct/article/24/10_Supplement/A076/766529/Abstract-A076-VS-7375-An-oral-selective-KRAS-G12DAbstract A076: VS-7375: An oral, selective KRAS G12D dual ...
VS-7375 monotherapy exhibited compelling initial overall response rates (confirmed 12/23) and 42% (5/12) in patients with pancreatic and lung ...
3.
cancernetwork.com
cancernetwork.com/view/novel-oral-kras-g12d-inhibitor-receives-fda-fast-track-designation-in-advanced-pdacNovel Oral KRAS G12D Inhibitor Receives FDA Fast Track ...
At the data cutoff of May 16, 2025, in 23 patients with PDAC treated at the target dose range, the overall response rate (ORR) was 52% (90% CI, ...
4.
targetedonc.com
targetedonc.com/view/vs-7375-shows-early-promise-against-kras-g12-mutant-solid-tumorsVS-7375 Shows Early Promise Against KRAS G12D ...
4 out of 5 efficacy-evaluable patients (80%) who have reached response assessment have experienced a tumor reduction and remain on treatment.
A Phase 1/2 Study of VS-7375 in Patients With KRAS ...
VS-7375 demonstrated an encouraging safety profile and was generally well-tolerated across all monotherapy dose levels evaluated to date.
6.
investor.verastem.com
investor.verastem.com/news-releases/news-release-details/verastem-oncology-doses-first-patient-target-d-201-phase-2Verastem Oncology Doses First Patient in TARGET-D 201 ...
The study is also evaluating VS-7375 900 mg and cetuximab in the first-line mPDAC setting, representing a potential chemotherapy-free frontline ...
A Phase 2 Study of VS-7375 in Patients With KRAS G12D- ...
This study will assess the safety and efficacy of VS-7375 alone and in combination with cetuximab in patients with metastatic KRAS G12D - ...
8.
ctv.veeva.com
ctv.veeva.com/study/a-phase-2-study-of-vs-7375-in-patients-with-kras-g12d-mutated-pancreatic-cancerA Phase 2 Study of VS-7375 in Patients With KRAS G12D ...
This study will assess the safety and efficacy of VS-7375 alone and in combination with cetuximab in patients with metastatic KRAS G12D ...
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