NCT06678659

A Study of REC-1245 in Participants With Unresectable, Locally Advanced, or Metastatic Cancer

A Phase 1 / 2, Open-Label Study of REC-1245 in Participants With Unresectable, Locally Advanced, or Metastatic Cancer

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 85 (estimated)
• Sponsor: Recursion Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, open-label study to investigate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (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.

Detailed description

Approximately 85 participants will be enrolled in this open-label Phase 1/2 study, allocated 55 participants in Phase 1 and 10-30 participants 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.

Conditions

• Unresectable
• Locally Advanced
• Metastatic Cancers
• Relapsed/Refractory Lymphomas

Interventions

Type	Name	Description
DRUG	REC-1245	Oral

Timeline

• Start date: 2024-11-21
• Primary completion: 2028-10-30
• Completion: 2028-10-30
• First posted: 2024-11-07
• Last updated: 2025-12-05

Locations

6 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study