Imlunestrant/Abemaciclib/Selinexor in Ovarian and Endometrial

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT07832227
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Imlunestrant — DRUG
    Oral study drug Taken once per day
  • Abemaciclib — DRUG
    Oral study drug Taken twice per day
  • Selinexor — DRUG
    Oral study drug Taken once per week

Study Details

This is a phase 2, interventional treatment trial evaluating imlunestrant, abemaciclib, and selinexor in two separate patient cohorts: low grade serous ovarian cancer and endometrioid endometrial cancer. The study is non-randomized and open-label. Treatment is administered in the outpatient setting, with a 14-day Cycle 0 followed by 28-day treatment cycles.

Key Dates

First listed
Sep 21, 2026
Start date
Dec 1, 2026
Status verified
Sep 2026
Primary completion
Dec 1, 2028
Completion
Aug 1, 2029

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1A - Low grade serous ovarian cancer cohort
    Participants in Cohort 1A receive combination treatment with imlunestrant, abemaciclib, and selinexor. Treatment is outpatient, with a 14-day Cycle 0 followed by 28-day cycles.
  • Experimental: 1B - Endometrioid endometrial cancer cohort
    Participants in Cohort 1A receive combination treatment with imlunestrant, abemaciclib, and selinexor. Treatment is outpatient, with a 14-day Cycle 0 followed by 28-day cycles.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: Treatment duration depends on individual response, evidence of disease progression, and treatment tolerance. On average, up to 1 year. ]

Central Contacts

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