180 Participants NeededMy employer runs this trial

VS-7375 + Cetuximab for Pancreatic Cancer

Recruiting at 28 trial locations
VC
LC
Overseen ByLuke Chung, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

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

I am fully active or restricted in physically strenuous activity only.
I have been diagnosed with pancreatic ductal adenocarcinoma.
My cancer has the KRAS G12D mutation confirmed by a local test.
See 4 more

Exclusion Criteria

I have taken a direct RAS inhibitor before.
I have another known RAS gene mutation.
I have not had any cancer treatment in the past 4 weeks.
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive VS-7375 alone or in combination with cetuximab for metastatic KRAS G12D-mutated pancreatic cancer

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Pharmacokinetics and Pharmacodynamics Assessment

Assessment of plasma pharmacokinetics and pharmacodynamics of VS-7375

20 weeks

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

Group I: VS-7375 MonotherapyExperimental Treatment1 Intervention
Group II: VS-7375 + cetuximab 2L PDACExperimental Treatment2 Interventions
Group III: VS-7375 + cetuximab 1L PDACExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Verastem, Inc.

Lead Sponsor

Trials
42
Recruited
2,800+

Citations

Press 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 ...

Abstract 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 ...

Novel 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, ...

VS-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.

Verastem 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 - ...

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 ...