105 Participants NeededMy employer runs this trial

VS-7375 for Non-Small Cell Lung Cancer

(TARGET-D 202 Trial)

Recruiting at 15 trial locations
VC
TW
Overseen ByTing Wu, 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 explores a new treatment, VS-7375 (experimental treatment), for individuals with metastatic Non-Small Cell Lung Cancer (NSCLC) that has a KRAS G12D mutation. Researchers aim to assess the safety and effectiveness of VS-7375 both alone and in combination with another drug, cetuximab. The trial includes various patient groups, such as those with brain metastases. It seeks participants who have previously tried one or more treatments for advanced NSCLC but have experienced cancer progression. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial requires stopping certain medications before starting, such as strong CYP3A4 inhibitors/inducers and PPIs or H2 blockers. You should discuss your current medications with the trial team to see if any need to be stopped.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that VS-7375 is generally safe. Studies found that people tolerated it well at different doses and with various types of tumors, including those with the KRAS G12D mutation. Most participants did not experience severe side effects.

Additionally, in patients with advanced non-small cell lung cancer, side effects were usually mild or manageable. Although the treatment remains under study, these findings offer encouragement for those considering joining the trial.12345

Why do researchers think this study treatment might be promising for lung cancer?

Unlike the standard treatments for non-small cell lung cancer, such as chemotherapy, targeted therapy, and immunotherapy, VS-7375 is a new investigational drug with a unique mechanism of action. It promises to target cancer cells more precisely, potentially leading to better outcomes with fewer side effects. Researchers are particularly excited about VS-7375 because it offers hope for patients with advanced stages of the disease, including those with brain metastasis, where current options are often limited. Its innovative approach could change the landscape of treatment for this challenging condition.

What evidence suggests that VS-7375 might be an effective treatment for Non-Small Cell Lung Cancer?

Research has shown that VS-7375 yields promising results for treating non-small cell lung cancer (NSCLC), particularly in patients with the KRAS G12D genetic mutation. Specifically, studies found that 68.8% of these patients experienced tumor shrinkage, indicating strong anti-tumor effects. Additionally, VS-7375 is generally well-tolerated, demonstrating a good safety profile. In this trial, participants will receive VS-7375 in various dosing regimens, potentially offering an effective treatment option for this type of lung cancer.23456

Are You a Good Fit for This Trial?

This trial is for adults with advanced or metastatic non-small cell lung cancer that has a KRAS G12D mutation. Participants must have already tried standard treatments like platinum-based chemo and immunotherapy, have good organ function, and be in generally good physical condition.

Inclusion Criteria

My cancer has a confirmed KRAS G12D mutation.
I have tumors that can be measured on scans.
My disease got worse during or after my last treatment.
See 7 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 monotherapy or in combination with cetuximab for KRAS G12D-mutated NSCLC

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

  • VS-7375

Trial Overview

The study is testing the safety and effectiveness of a new drug called VS-7375, given alone or together with cetuximab, in people whose lung cancer has spread and carries the KRAS G12D mutation.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Group I: VS-7375 Monotherapy 2L/3L Preferred DoseExperimental Treatment1 Intervention
Group II: VS-7375 Monotherapy 2L/3LExperimental Treatment1 Intervention
Group III: 2L-4L with brain metastasisExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Verastem, Inc.

Lead Sponsor

Trials
42
Recruited
2,800+

Citations

Press Release - Verastem, Inc.

GFH375 demonstrated an overall response rate (ORR) of 68.8% in non-small cell lung cancer (NSCLC) demonstrated an ORR of 57.7% in efficacy ...

NCT07020221 | A Phase 1/2 Study of VS-7375 in Patients ...

This study will assess the safety and efficacy of VS-7375 alone and in combination in patients with advanced solid tumors harboring a KRAS G12D-mutation.

Novel KRAS G12D Inhibitor Shows Promising Efficacy in ...

VS-7375 demonstrated a 68.8% ORR in advanced NSCLC with KRAS G12D mutation, indicating significant efficacy. The study population was heavily ...

Verastem Oncology Doses First Patient in TARGET-D 202 ...

VS-7375 demonstrated encouraging anti-tumor activity across multiple KRAS G12D- is a potential best-in-class, potent, and selective

5.

clinicaltrials.cedars-sinai.edu

clinicaltrials.cedars-sinai.edu/view/VS-7375-101

VS-7375 in Advanced KRAS G12D-Mutant Solid Tumors

The purpose of the study is to determine the safety and best dose of an experimental drug called VS-7375 in these patients.VS-7375

VS-7375 Demonstrates Clinical Activity with a Favorable ...

The data demonstrate encouraging clinical activity along with a favorable safety and tolerability profile across multiple dose levels and tumor types, non- ...