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

ClinicalTrials.gov ID

NCT06678659

Lead Sponsor

Recursion Pharmaceuticals Inc.INDUSTRY

Overall Status

Recruiting

Study Type

Interventional

Phase

Phase 1Phase 2

Enrollment

170Estimated

Last Update Posted

Aug 20, 2026Actual

Start Date

Nov 21, 2024Actual

Primary Completion Date

Oct 30, 2028Estimated

Completion Date

Oct 30, 2028Estimated

Official Title

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

Brief 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

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.

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

• REC-1245

Ages Eligible for Study

Child (0-17)Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility 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

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Sequential Assignment

Masking

None (Open Label)

Lead Sponsor

Recursion Pharmaceuticals Inc.INDUSTRY

canceranswer@ccf.org216-444-7923

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