A Phase 2 Study of Avutometinib (VS-6766) Plus Defactinib (NCT05512208) | Clinical Trial Compass
RecruitingPhase 2
A Phase 2 Study of Avutometinib (VS-6766) Plus Defactinib
United States55 participantsStarted 2023-02-06
Plain-language summary
The purpose of this research is to test the effectiveness and safety of the study drugs (VS-6766 and defactinib), and see what effects (good and bad) these drugs have on the patients with endometrioid cancer, mucinous ovarian cancer, high-grade serous ovarian cancer, or solid gynecological cancer.
Who can participate
Age range18 Years – 99 Years
SexFEMALE
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Inclusion criteria
✓. Female subjects ≥ 18 years of age.
✓. Histologically proven gynecological cancers (endometrioid, MOC, HGSOC and solid gynecological cancers) with mutated RAS, BRAF (type I, II, and/or III), NF-1 loss of function, and/or RAS activation.
✓. Mutational status will be taken from the previous next-gen sequencing (NGS) or molecular testing results and reviewed by the Principal Investigator prior to the start of treatment.
✓. Adequate pathology material (as defined in the lab manual) must be available prior to treatment assignment to be used for confirmation.
✓. Tumor with known RAS mutation, BRAF (type I, II, and/or III) mutation, NF-1 and/or RAS activation status determined from previous NGS or molecular testing. Adequate archival tumor tissue less than 5 years old or fresh biopsy tissue samples (as defined in the lab manual) must be available.
✓. Progression (radiographic or clinical) or recurrence of gynecological cancer after at least one prior systemic therapy for metastatic disease. Below are additional prior treatments that are allowed once the requirement of prior platinum therapy is satisfied.
✓. Measurable disease according to RECIST 1.1.
✓. An Eastern Cooperative Group (ECOG) performance status ≤ 2.
Exclusion criteria
✕. Systemic anti-cancer therapy within 4 weeks of the first dose of study therapy.
✕. Prior MEKi or RAFi exposure.
What they're measuring
1
Proportion of Patients with objective response rate
✕. History of prior malignancy with recurrence \<3 years from the time of enrollment. Subjects with basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, and in situ cervical cancer that has undergone potentially curative therapy with no evidence of disease recurrence for ≥1 year since completion of the appropriate therapy may be included. Subjects with other malignancies associated with very low risk of metastasis or death may be included upon discussion with the PI.
✕. Subjects who are deemed in the opinion of their treating physician to be appropriate candidates for a debulking surgery. These subjects should preferentially receive surgery prior to consideration of trial therapy.
✕. Major surgery within 4 weeks (excluding placement of vascular access), minor surgery within 2 weeks, or palliative radiotherapy within 1 week (7 days) of the first dose of study therapy.
✕. Treatment with warfarin. Subjects on warfarin for DVT/PE can be converted to low-molecular weight heparin (LMWH) or direct oral anticoagulants (DOACs).
✕. Exposure to strong CYP2C9 and CYP3A4 inhibitors or inducers within 14 days prior to the first dose and during the course of therapy. See Table 14 and Table 15 for representative lists of CYP inhibitors and inducers. For additional guidance, see https://www.fda.gov/drugs/drug-interactions-labeling/drug-development-and-druginteractions-table-substrates-inhibitors-and-inducers.