150 Participants NeededMy employer runs this trial

VS-7375 for Colorectal Cancer

(TARGET-D 203 Trial)

Recruiting at 16 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 tests a new treatment, VS-7375, for individuals with metastatic colorectal cancer that has a specific KRAS G12D mutation. Researchers aim to determine if VS-7375 is safe and effective alone or when combined with other drugs like cetuximab or panitumumab, and in some cases, a chemotherapy regimen called mFOLFOX. Ideal candidates for this trial have already received standard chemotherapy for their metastatic colorectal cancer and have experienced disease progression. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in cancer treatment.

Will I have to stop taking my current medications?

The trial requires stopping certain medications before starting. You must stop taking strong CYP3A4 inhibitors/inducers or sensitive substrates within 14 days, and PPIs or H2 blockers within 5 days before the first treatment dose.

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

Research has shown that VS-7375 was generally well-tolerated in earlier studies. At doses of 400 mg and 600 mg per day, no serious side effects prevented dose escalation, indicating patients could handle these amounts without major issues.

Further findings reveal that VS-7375 remains safe even at higher doses, such as 600 mg and 900 mg daily. Most side effects were mild and manageable, suggesting the treatment is quite safe for patients with conditions similar to those in the current trial.

In summary, previous research on VS-7375 indicates it is well-tolerated with mostly mild side effects. This evidence supports its continued testing and potential use in treating colorectal cancer with specific genetic mutations.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about VS-7375 for colorectal cancer because it offers a fresh approach compared to standard treatments like chemotherapy and targeted therapies such as cetuximab and bevacizumab. VS-7375 is unique as it targets specific pathways involved in cancer cell growth, potentially offering a more precise attack on tumors with fewer side effects. In the trial, VS-7375 is being tested alone and in combination with other treatments like cetuximab and mFOLFOX, which may enhance its effectiveness. This innovative strategy could lead to more personalized and effective treatment options for patients with colorectal cancer.

What evidence suggests that this trial's treatments could be effective for metastatic KRAS G12D-mutated colorectal cancer?

Research has shown that the drug VS-7375 yields promising results for patients with KRAS G12D-mutated tumors. In an earlier study, four out of five patients experienced tumor shrinkage after using VS-7375, suggesting the drug can help reduce tumor size. Another study with lung cancer patients who had the same mutation found that 68.8% responded well to the treatment, indicating a positive reaction in most cases. In this trial, participants will receive VS-7375 either as monotherapy or in combination with other treatments. These findings suggest that VS-7375 could effectively treat cancers with the KRAS G12D mutation, including colorectal cancer.12467

Are You a Good Fit for This Trial?

This trial is for adults with metastatic colorectal cancer that has a specific KRAS G12D mutation. Participants must have tried at least one standard chemotherapy, have measurable disease, good physical health (ECOG 0 or 1), and their cancer must have gotten worse after previous treatment.

Inclusion Criteria

I had stable disease or a positive response to at least one previous treatment.
I have been diagnosed with metastatic colorectal cancer.
I have tumors that can be measured on scans.
See 5 more

Exclusion Criteria

I have not had any anti-cancer treatment in the past 4 weeks.
Inability to swallow oral medication
I have a known RAS gene mutation in my cancer.
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 or panitumumab, and cetuximab plus mFOLFOX

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

Quality of Life Assessment

Assessment of health-related quality of life using EORTC QLQ-C30

24 months

What Are the Treatments Tested in This Trial?

Interventions

  • cetuximab
  • Cetuximab + mFOLFOX6
  • panitumumab
  • VS-7375

Trial Overview

The study tests the safety and effectiveness of a new drug called VS-7375 alone or combined with cetuximab, panitumumab, or cetuximab plus mFOLFOX6 in people with this type of colorectal cancer.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Group I: VS-7375 with chosen regimen in 2L+ CRCExperimental Treatment3 Interventions
Group II: VS-7375 Monotherapy or Preferred Combination in 2L+ CRCExperimental Treatment3 Interventions
Group III: VS-7375 + cetuximab and mFOLFOX in 1L CRCExperimental 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

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 ...

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 ...

4.

clinicaltrials.cedars-sinai.edu

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

VS-7375 in Advanced KRAS G12D-Mutant Solid Tumors

This study focuses on people who have been diagnosed with a solid tumor that contains a specific change (mutation) in the KRAS gene. One common mutation.

Verastem Oncology Announces Encouraging Preliminary ...

VS-7375 that has previously demonstrated at least one scan, four out of five patients have had a tumor reduction and are still on treatment.

VS-7375 Exhibits Activity in KRAS G12D–Mutated Solid ...

VS-7375 monotherapy showed a favorable and manageable safety profile at the 600-mg (n = 57) and 900-mg (n = 25) dose levels.

VS-7375 Shows Early Promise Against KRAS G12D ...

VS-7375 shows promising safety and antitumor activity in KRAS G12D-mutated solid tumors, with no dose-limiting toxicities at 400 mg and 600 mg ...