A Study of REC-1245 in Participants with Unresectable, Locally Advanced, or Metastatic Cancer
Sponsor: Recursion Pharmaceuticals Inc.
ClinicalTrials ID:NCT06678659
This multi-center, open-label Phase 1/2 study evaluates the safety, tolerability, and pharmacokinetics of REC-1245 in 85 participants with unresectable, locally advanced, or metastatic solid tumors. Eligible individuals are 18+, with progressive disease and ECOG ≤ 1. REC-1245 is administered orally in 1mg, 5mg, or 25mg capsules for up to 2 years.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
This is a multi-center, open-label study to investigate the safety, tolerability, PK, PD, and preliminary activity of REC-1245 administered orally on a once daily (QD) schedule in participants with unresectable, locally advanced, or metastatic solid tumors.
Description
Approximately 85 individuals will be enrolled in this open-label Phase 1/2 study, allocated 55 individuals in Phase 1 and 10-30 individual's in Phase 2. The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of REC-1245 for the treatment of participants with unresectable locally advanced or metastatic solid tumors. Participants will receive treatment with REC-1245 for up to 2 years.
Eligibility Criteria
Inclusion Criteria
- 18 years or older 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.
ECOG performance status ≤ 1 Measurable disease at baseline per RECIST 1.1 / Lugano criteria and documented by computed CT and / or MRI
Exclusion Criteria
- Received treatment with another RBM39 degrader Clinically significant gastrointestinal (GI) or GI malabsorption
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| City of Hope | 91010 | Duarte | California |
| Cleveland Clinic | 44195 | Cleveland | Ohio |
| SCRI Oncology Partners - PPDS | 37203 | Nashville | Tennessee |
| START Mountain Region | 84119 | West Valley City | Utah |
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