RECRUITING

A Phase 1/2a Study of VS-7375 in Patients With KRAS G12D-Mutated Solid Tumors

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Conditions

Pancreatic Ductal AdenocarcinomaNon Small Cell Lung CancerColorectal CancerSolid Tumor, AdultG12D Mutated KRASKRAS G12D mutationSolid tumorsLung CancerMetastatic CancerPancreatic CancerNSCLCCRCPDACPancreatic NeoplasmsColorectal NeoplasmsLung NeoplasmsGastrointestinal NeoplasmsKRASRAS

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 1/2a, Open-label Study of VS-7375, a KRAS G12D (ON/OFF) Inhibitor, as Monotherapy and in Combination, in Patients With Advanced KRAS G12D-Mutated Solid Tumors

Quick Facts

Study Start:2025-06
Study Completion:2028-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07020221

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Individuals ≥18 years of age.
  2. * Agreement to sign and date an informed consent form (ICF) approved by the Institutional Review Board (IRB)/Independent Ethics Committee (IEC).
  3. * Histologic or cytologic evidence of locally advanced unresectable or metastatic solid tumor harboring a KRAS G12D mutation.
  4. * Must have received ≥1 prior line of standard systemic therapy for advanced or metastatic disease or experienced cancer progression within 6 months of neoadjuvant or adjuvant therapy.
  5. * Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
  6. * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  7. * Adequate organ function
  8. * Adequate cardiac function
  9. * Recovered from all AEs due to previous therapies to Grade ≤1 or baseline.
  10. * Agreement to use highly effective contraception
  1. * Underwent major surgical procedure as defined by the Investigator, other than for diagnosis, within 4 weeks prior to Cycle 1 Day 1,
  2. * Receipt of chemotherapy, targeted therapy, or radiotherapy (excluding palliative radiation) within 4 weeks or 5 half-lives, whichever is shorter, or immunotherapy within 4 weeks prior to Cycle 1 Day 1
  3. * Treatment with any investigational drug at least 4 weeks or 5 half-lives, whichever is shorter, prior to Cycle 1 Day 1.
  4. * History of treatment with direct and specific KRAS G12D inhibitors.
  5. * Symptomatic, untreated, or actively progressing known central nervous system (CNS) metastases.
  6. * Inability to swallow oral medications.
  7. * Evidence or history of uncontrolled, clinically significant hematological, renal, hepatic, endocrine, pulmonary, gastrointestinal, cardiovascular, psychiatric, coagulation, neurologic, dermatologic, autoimmune, or allergic disease
  8. * Individuals who are pregnant or breastfeeding.

Contacts and Locations

Study Contact

Verastem Call Center
CONTACT
1 781 292 4204
clinicaltrials@verastem.com

Study Locations (Sites)

SCRI Oncology Partners
Nashville, Tennessee, 37203
United States
MD Anderson Cancer Center
Houston, Texas, 77030
United States
Virginia Mason Medical Center
Seattle, Washington, 98101
United States

Collaborators and Investigators

Sponsor: Verastem, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06
Study Completion Date2028-09

Study Record Updates

Study Start Date2025-06
Study Completion Date2028-09

Terms related to this study

Keywords Provided by Researchers

  • KRAS G12D mutation
  • Solid tumors
  • Non Small Cell Lung Cancer
  • Lung Cancer
  • Colorectal Cancer
  • Metastatic Cancer
  • Pancreatic Cancer
  • Pancreatic Ductal Adenocarcinoma
  • NSCLC
  • CRC
  • PDAC
  • Pancreatic Neoplasms
  • Colorectal Neoplasms
  • Lung Neoplasms
  • Gastrointestinal Neoplasms
  • KRAS
  • RAS

Additional Relevant MeSH Terms

  • Pancreatic Ductal Adenocarcinoma
  • Non Small Cell Lung Cancer
  • Colorectal Cancer
  • Solid Tumor, Adult
  • G12D Mutated KRAS