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

NCT07633756 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: 2026-0176NCI-2026-04229
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

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

  Through study completion; an average of 1 year

Study Arms (1)

Treatment with REC617

EXPERIMENTAL

Participants will receive REC-617 orally at a dose of 10 mg once daily

Drug: REC617

Interventions

REC617 DRUG

Given by PO

Treatment with REC617

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Participants who are receiving any other investigational agents or have received any other investigational agent within 3 weeks prior to enrollment.
• Current enrollment in another clinical study unless it is non-interventional or the follow-up period of an interventional study.
• Prior treatment with radiotherapy (including radio-labeled spheres and/or cyberknife, hepatic arterial embolization (with or without chemotherapy) or cryotherapy/ablation) is allowed if these therapies did not affect the areas of measurable disease being used for this protocol.
• Received medications known to prolong QTc within 5 half-lives before the first dose of the study treatment. List of medications that prolong QTc can be obtained from crediblemeds.org.
• Administration of a live vaccine within 28 days of starting study treatment and for up to 1 month after the final dose of study treatment or anticipation that such vaccine will be required during the study. Note: mRNA-based vaccines for COVID-19 are allowed as well as inactivated flu vaccines.
• Has had or is scheduled to have major surgery \<28 days prior to the first dose of study treatment.
• Active concurrent second malignancy within 2 years of trial enrollment. Note: Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. Examples include non-melanomatous skin cancer, in situ carcinoma, or low-risk prostate cancer.
• Unresolved or unstable toxic side-effects of prior anticancer therapy, except fatigue, alopecia, infertility, peripheral neuropathy, or those relating to palliative radiotherapy within 6 weeks prior to first dose of study treatment will have resolved to Grade 1 or less.
• C. Other comorbidities affecting participation
• Active gastrointestinal bleeding.
• Evidence of severe or uncontrolled systemic disease or psychiatric illness that, in the investigator's judgment, would limit safety or compliance.
• Impaired gastrointestinal absorption
• History of allergic reactions to compounds like REC-617. D. Transplant History
• Prior organ or allogeneic stem-cell transplantation

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Leiomyosarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Study Officials

• Elise Nassif, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elise Nassif, MD

CONTACT

281-460-0607; efnassif@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2026
• First Posted: June 8, 2026
• Study Start (Estimated): October 19, 2026
• Primary Completion (Estimated): December 26, 2029
• Study Completion (Estimated): December 26, 2031
• Last Updated: June 8, 2026

Record last verified: 2026-06

Locations

US (1)