Investigating REC-1245 for advanced or metastatic cancer
A Phase 1 / 2, Open-Label Study of REC-1245 in Participants With Unresectable, Locally Advanced, or Metastatic Cancer
This study is testing a new oral medication called REC-1245 to see if it can help people with advanced or metastatic cancer who haven't responded well to standard treatments.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 170 (estimated) |
| Ages | 12 Years and up |
| Sex | All |
| Sponsor | Recursion Pharmaceuticals Inc. Industry-sponsored |
| Locations | 6 sites (Duarte, California and 5 other locations) |
| Trial ID | NCT06678659 on ClinicalTrials.gov |
What this trial studies
This multi-center, open-label study aims to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary activity of REC-1245, an oral medication administered once daily, in participants with unresectable, locally advanced, or metastatic solid tumors. Approximately 85 individuals will be enrolled, with 55 in Phase 1 and 10-30 in Phase 2, receiving treatment for up to 2 years. The study focuses on those who have experienced disease progression or have been intolerant to standard therapies.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with unresectable, locally advanced, or metastatic solid tumors or relapsed/refractory lymphomas who have not responded to standard treatments.
Not a fit: Patients who have received treatment with another RBM39 degrader or have significant gastrointestinal issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat advanced cancers.
How similar studies have performed: While this approach is novel, similar studies targeting advanced cancers have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Have histologically-confirmed unresectable, locally advanced, or metastatic select solid tumors or select relapsed / refractory lymphoma * Have experienced progressive disease, relapsed disease, or be intolerant to at least one established standard systemic anti-cancer treatment for a given tumor type, or have been considered ineligible for standard therapy. * Eastern cooperative oncology group (ECOG) performance status ≤1; for adolescent participants, Lansky Performance Status Scale or Karnofsky Performance Status Scale score of ≥70. * Measurable disease at baseline per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 / Lugano criteria and documented by computed tomography (CT) and / or magnetic resonance imaging (MRI) Exclusion Criteria: * Received treatment with another RBM39 degrader * Clinically significant gastrointestinal (GI) or GI malabsorption
Where this trial is running
Duarte, California and 5 other locations
- City of Hope — Duarte, California, United States (Recruiting)
- Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
- SCRI Oncology Partners - PPDS — Nashville, Tennessee, United States (Withdrawn)
- START Mountain Region — West Valley City, Utah, United States (Recruiting)
- Princess Margaret Cancer Centre — Toronto, Ontario, Canada (Recruiting)
- McGill University Health Centre (MUHC) - The Montreal — Québec, Canada (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.