Tests avutometinib with defactinib in recurrent low-grade serous ovarian cancer

Trial details

Who runs it

Verastem, Inc.

Trial code

NCT06072781EU 2023-508204-38-00

Record updated

2 November 2026

Original description

This study will assess the safety and efficacy of avutometinib (VS-6766) in combination with defactinib versus Investigator's choice of treatments (ICT) in subjects with recurrent LGSOC who have progressed on a prior platinum-based therapy.Read full original descriptionShow less

A Phase 3, Randomized, Open-Label Study of Combination Therapy With Avutometinib Plus Defactinib Versus Investigator's Choice of Treatment in Patients With Recurrent Low-Grade Serous Ovarian Cancer (LGSOC) (RAMP 301)

This study will assess the safety and efficacy of avutometinib (VS-6766) in combination with defactinib versus Investigator's choice of treatments (ICT) in subjects with recurrent LGSOC who have progressed on a prior platinum-based therapy.

Inclusion: Patients may be eligible for inclusion in the study if they meet the following criteria:; Histologically proven LGSOC (ovarian, fallopian, peritoneal); Documented mutational status of KRAS by a validated tumor-tissue based diagnostic test; Suitable for treatment with at least one of the Investigator's Choice of Treatments:pegylated liposomal doxorubicin, paclitaxel, letrozole, anastrozole; Progression or recurrence of LGSOC after at least one prior systemic therapy for metastatic disease; Measurable disease according to RECIST v1.1; An Eastern Cooperative Group (ECOG) performance status ≤ 1; Adequate organ function; Adequate recovery from toxicities related to prior treatments; For patients with reproductive potential, a negative pregnancy test must be confirmed and agreement to use highly effective method of contraceptive; Willingness to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures.

Exclusion: Prior treatment with avutometinib, defactinib, or other FAK inhibitors; Major surgery within 4 weeks, minor surgery within 1 week, or palliative radiotherapy within 1 week of the first dose of study intervention; Symptomatic brain metastases requiring steroids or other interventions, known leptomeningeal metastases, or spinal cord compression; For subjects with prior MEK or RAF exposure, Grade 4 toxicity is deemed related to the MEK inhibitor; Concurrent ocular disorders; Concurrent heart disease or severe obstructive pulmonary disease; Subjects with the inability to swallow oral medications; History of hypersensitivity to any of the active agents or ingredients of study intervention: peanut, soya, polyoxyl castor oil, etcetc.). Prior hypersensitivity to anthracyclines or anthracenediones if the use of pegylated liposomal doxorubicin (PLD) is planned; Systemic anti-cancer therapy within 4 weeks of the first dose of study therapy; Co-existing high-grade serous ovarian cancer or mixed histology; An active skin disorder that has required systemic therapy within one year of the first dose of study intervention; History of medically significant rhabdomyolysis; Active or past medical history of interstitial lung disease/pneumonitis, including drug-induced or radiation pneumonitis, pulmonary fibrosis, or adult respiratory distress syndrome (ARDS); Active, uncontrolled infection (bacterial, viral, or fungal) requiring systemic therapy; History of prior malignancy with recurrence <3 years from the time of enrollment; Patients will be excluded from the study if they meet any of the following criteria:; Symptomatic bowel obstruction within 3 months of the first dose of study intervention; Pregnant or breastfeeding.

ClinicalTrials.gov NCT06072781 · EU CTIS 2023-508204-38-00