15 Participants NeededMy employer runs this trial

REC-617 for Leiomyosarcoma

EN
Overseen ByElise Nassif, MD
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: M.D. Anderson Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a new drug, REC-617, can help control leiomyosarcoma, a cancer affecting smooth muscle tissue. The study also aims to ensure the drug's safety for patients. Suitable candidates for this trial have RB1-negative leiomyosarcoma (a tumor type lacking a certain protein) and have previously tried at least one other cancer treatment. Participants must have a tumor that can be safely biopsied, excluding areas like bone metastases, and should be able to swallow pills. As a Phase 1 trial, this research focuses on understanding how REC-617 works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, you cannot be on other investigational agents or medications that prolong QTc before starting the study treatment.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that REC-617, the treatment under study for leiomyosarcoma, remains in the early testing stages. Initial safety information from these studies is expected soon. As a Phase 1 trial, researchers primarily focus on determining if REC-617 is safe for humans. This phase assesses whether the treatment is well-tolerated and identifies potential side effects.

Although detailed safety information is not yet available, REC-617's progression to this stage suggests some early evidence of safety. However, as this is an early trial, unknowns about its safety may still exist. Researchers closely monitor participants to ensure their safety throughout the trial.12345

Why do researchers think this study treatment might be promising for LMS?

REC-617 is unique because it offers a new approach to treating leiomyosarcoma, a rare type of cancer. While current treatments like surgery, radiation, and chemotherapy focus on removing or destroying cancer cells, REC-617 is taken as a pill, providing a potentially less invasive option. Researchers are excited because it targets the cancer differently, possibly offering effectiveness with fewer side effects compared to traditional methods. This novel approach could pave the way for more convenient and targeted cancer treatments.

What evidence suggests that REC-617 might be an effective treatment for leiomyosarcoma?

Research has shown that REC-617, the treatment under study in this trial, holds promise for treating leiomyosarcoma (LMS), a rare type of cancer. It targets CDK7, a protein that aids cancer cell growth. In early studies, some patients responded to the treatment even after other therapies failed. Specifically, one patient experienced benefits for over six months despite having advanced cancer. These early results suggest that REC-617 might help control LMS by inhibiting its growth.12678

Who Is on the Research Team?

EN

Elise Nassif, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults (18+) with leiomyosarcoma that cannot be removed by surgery or has spread, whose tumors are RB1-negative. Participants must have had at least one previous treatment, be able to swallow pills, and have a life expectancy over 3 months.

Inclusion Criteria

I am able to care for myself and do daily activities.
I meet the required guidelines for past and current treatments.
I have received at least one previous systemic treatment for my condition.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

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

12-24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Long-term follow-up

Participants are monitored for overall survival and progression-free survival

1 year

What Are the Treatments Tested in This Trial?

Interventions

  • REC-617

Trial Overview

The study is testing REC-617, an experimental drug targeting CDK7, in people with advanced or metastatic RB1-negative leiomyosarcoma. All participants receive the drug and are monitored for safety and effectiveness.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Treatment with REC617Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

Citations

Recursion Reports Interim Phase 1 Clinical Data for REC- ...

ELUCIDATE is a multicenter, open-label, two-stage clinical trial to evaluate safety, pharmacokinetics, pharmacodynamics, and efficacy of REC-617 in advanced ...

REC-617 for Leiomyosarcoma · Info for Participants

The study is testing REC-617, an experimental drug targeting CDK7, in people with advanced or metastatic RB1-negative leiomyosarcoma. All participants receive ...

Recursion Reports Interim Phase 1 Clinical Data for REC ...

The response is on-going after more than 6 months of treatment. This patient had progressed following 4 lines of prior therapy in the advanced ...

Therapeutic advances in leiomyosarcoma - PMC

The estimated median PFS was 9.2 months, 8.2 months, 4.8 months, median OS was 36.8 months, 21.9 months, 30.3 months, with ORR of 30.9%, 19.5% ...

Recursion Pharmaceuticals Advances AI-Powered Cancer ...

Recursion Pharmaceuticals has advanced its lead cancer drug candidate REC-617, a novel CDK7 inhibitor, to phase 2 clinical trials with top-line ...

Retrospective Review of Efficacy and Safety of Anlotinib in ...

Conclusions. In summary, our results indicate that anlotinib is reliable, safe and feasible for advanced leiomyosarcoma. Anlotinib combined with ...

NCT06088290 | Study of Lurbinectedin in Combination ...

The primary objective of this phase III trial is to evaluate whether the combination of lurbinectedin plus doxorubicin given as first line treatment for ...

Recursion Reports Q2 Business Updates and Financial Results

Early safety and PK data from the Phase 1 dose-escalation portion is on track for the first half of 2026. ▪️ Target patient population for REC-617 ...