A Phase 1b, Open-Label Study Of REC-617, A Selective CDK7 Inhibitor, In Patients With Metastatic Or Unresectable RB1-Negative Leiomyosarcoma After Prior Systemic Therapy

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT07633756
Phase
PHASE1
Status
Recruiting
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Conditions

  • Leiomyosarcoma
  • Open Label
  • Phase 1b
  • RB1-Negative
  • REC-617

Eligibility Criteria

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

Interventions

  • REC617 — DRUG
    Given by PO

Study Details

To learn if the study drug REC-617 can help to control LMS. The safety of REC-617 will also be studied.

Key Dates

First listed
Jun 8, 2026
Start date
Oct 19, 2026
Status verified
Jul 2026
Primary completion
Dec 26, 2029
Completion
Dec 26, 2031

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment with REC617
    Participants will receive REC-617 orally at a dose of 10 mg once daily

Primary Outcome Measure

Safety and adverse events (AEs). [ Time Frame: Through study completion; an average of 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MD Anderson Cancer CenterHoustonTexas77030
Elise Nassif, MD
[email protected]
281-460-0607
Elise Nassif, MD (PRINCIPAL_INVESTIGATOR)

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By research site
MD Anderson Cancer Center· Houston, TX

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