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

RecruitingPhase 1, Phase 2Ages 18 Years - anyAllVerastem, Inc.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Key Inclusion Criteria: * Individuals โ‰ฅ18 years of age. * Agreement to sign and date an informed consent form (ICF) approved by the Institutional Review Board (IRB)/Independent Ethics Committee (IEC). * Histologic or cytologic evidence of locally advanced unresectable or metastatic solid tumor harboring a KRAS G12D mutation. * Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * Adequate organ function * Adequate cardiac function * Recovered from all AEs due to previous therapies to Grade โ‰ค1 or baseline * Agreement to use highly effective contraception Key Exclusion Criteria: * Underwent major surgical procedure as defined by the Investigator, other than for diagnosis, within 4 weeks prior to Cycle 1 Day 1 * 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. * Treatment with any investigational drug at least 4 weeks or 5 half-lives, whichever is shorter, prior to Cycle 1 Day 1. * History of treatment with direct RAS inhibitors. * Symptomatic, untreated, or actively progressing known central nervous system (CNS) metastases. * Inability to swallow oral medications. * Evidence or history of uncontrolled, clinically significant hematological, renal, hepatic, endocrine, pulmonary, gastrointestinal, cardiovascular, psychiatric, coagulation, neurologic, dermatologic, autoimmune, or allergic disease. * Individuals who are pregnant or breastfeeding.
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What it tests

  • VS-7375
  • Cetuximab
  • Carboplatin + Pemetrexed + Pembrolizumab
  • Gemcitabine + Nab-paclitaxel
  • Pembrolizumab
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Where

20 sites
Cedars-Sinai Medical Center
Los Angeles, United States
Johns Hopkins University
Baltimore, United States
Massachusetts General Hospital
Boston, United States
University of Michigan
Ann Arbor, United States
Washington University School of Medicine
St Louis, United States
Laura & Isaac Perlmutter Cancer Center at NYU Langone
New York, United States
Univ of Pennsylvania, Abramson Cancer Center
Philadelphia, United States
SCRI Oncology Partners
Nashville, United States

โ€ฆand 12 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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