Trial NCT07020221
A Phase 1/2 Study of VS-7375 in Patients With KRAS G12D-Mutated Solid Tumors
- Phase
- Phase 1/2
- Sponsor
- Verastem, Inc.
- Conditions
- Pancreatic Ductal Adenocarcinoma; Non Small Cell Lung Cancer; Colorectal Cancer; Solid Tumor, Adult; G12D Mutated KRAS
- Ages
- 18+ years
Eligibility criteria
Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).
Key Inclusion Criteria:
* Individuals ≥18 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 1Performance status
* Adequate organ function
* Adequate cardiac functionCardiac
* Recovered from all AEs due to previous therapies to Grade ≤1 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.Brain 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.Pregnancy
Restrictions found (4)
- Brain metastasesConditionalexclusionShow in the text
- CardiacConditionalinclusionShow in the text
- Performance statusOutrightinclusion
ECOG 0 or 1
Show in the text - PregnancyOutrightexclusionShow in the text
Recruiting in Massachusetts
- Massachusetts General Hospital · Boston, Suffolk County