Phase Ib Study of Avutometinib, Defactinib, and Everolimus in RAS Pathway Mutant Endometrial Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18+
SponsorM.D. Anderson Cancer Center
About this trial
To find the recommended dose of the combination of avutometinib, defactinib, and everolimus in patients with endometrial cancer that is recurrent and has abnormal RAS activity. The safety and effects of this combination will also be studied.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants must have histologically or cytologically confirmed recurrent RAS mutant endometrial cancer. RAS pathway gene activating mutations include KRAS, NRAS, HRAS, BRAF, MEK1, and MEK2 activating mutations. Any endometrial histology is permitted, including endometrioid, clear cell, mesonephric, and serous.
Participants must have received prior immune checkpoint inhibition treatment alone or in combination.
Unlimited prior systemic therapies are permitted, including any number of prior MEK inhibitor regimens.
Ability to understand and willingness to sign a written informed consent document.
Disqualifiers
Participants who are pregnant or lactating.
Participants with sarcoma components of their endometrial cancer, except carcinosarcoma.
Radiation, chemotherapy, or immunotherapy or any other anticancer therapy ≤2 weeks prior to cycle 1 day 1.
Participation in an interventional anti-cancer study (clinical trial) within 3 weeks prior to cycle 1 day 1
Trial design
Design model
Single group
Treatments tested in this trial
Avutometinib
DrugGiven by PO
defactinib
DrugGiven by PO
Everolimus
DrugGiven by PO
Treatment groups
31 Participants
are divided into 2 treatment groupsGroup A: Dose EscalationExperimental treatment 3 interventions
Group B: Dose ExpansionExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Safety and adverse events (AEs).
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Time frame
Through study completion; an average of 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
M.D. Anderson Cancer Center
Lead sponsor
Verastem, Inc.
Collaborator
Source ClinicalTrials.gov