Clinical trial for Colorectal Cancer
Official title A Phase 2 Study of VS-7375 in Patients With KRAS G12D-Mutated Colorectal Cancer
ClinicalTrials.gov ID: NCT07659795
What this study is testing
What is VS-7375?
VS-7375 is an investigational medicine, taken by mouth, being studied as a potential treatment for colorectal cancer.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study will find out how safe VS-7375 is and whether it helps treat this type of cancer.
- Who it's for
- Adults who have metastatic colorectal cancer with a KRAS G12D mutation.
- What's involved
- Participants will take VS-7375 by itself or together with cetuximab or panitumumab and cetuximab plus mFOLFOX (a chemotherapy regimen), and will have regular clinic visits and tests.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histopathology confirmed metastatic CRC
- Measurable disease per RECIST 1.1
- Local testing confirmed KRAS G12D mutation (tissue required for confirmatory central testing)
- 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
You likely can't join if
- 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
See the full eligibility criteria
- Histopathology confirmed metastatic CRC
- Measurable disease per RECIST 1.1
- Local testing confirmed KRAS G12D mutation (tissue required for confirmatory central testing)
- 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
- Treatment-naïve or received no more than 1 cycle of standard systemic therapy for metastatic disease.
- 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
- Inability to swallow oral medication
- Other protocol-defined inclusion/exclusion criteria may apply
The study team makes the final eligibility decision.
Where it is enrolling
- Scottsdale, Arizona, United States
- Los Angeles, California, United States
- Coral Springs, Florida, United States
- Tamarac, Florida, United States
- Tampa, Florida, United States
- Indianapolis, Indiana, United States
- Grand Rapids, Michigan, United States
- St Louis, Missouri, United States
- East Brunswick, New Jersey, United States
- New York, New York, United States
- Chapel Hill, North Carolina, United States
- Cleveland, Ohio, United States
- Nashville, Tennessee, United States
- Fort Worth, Texas, United States
- Houston, Texas, United States
- Salt Lake City, Utah, United States
- West Valley City, Utah, United States
- Charlottesville, Virginia, United States
- Fairfax, Virginia, United States
- Seattle, Washington, United States
+ 8 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Scottsdale, Arizona, United States; Los Angeles, California, United States; Coral Springs, Florida, United States; Tamarac, Florida, United States; Tampa, Florida, United States; Indianapolis, Indiana, United States and 22 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.