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

NCT06678659 · Recursion Pharmaceuticals Inc.

Recruiting

In plain English

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Official title

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

About this study

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.

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. * Eastern cooperative oncology group (ECOG) performance status ≤ 1 * 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

Study design

Enrollment target: 85 participants

Allocation: randomized

Masking: none

Age groups: adult, older_adult

Timeline

Starts: 2024-11-21

Estimated completion: 2028-10-30

Last updated: 2025-12-05

Interventions

Drug: REC-1245

Primary outcomes

• Phase 1-Part 1A (Dose Finding)- Assessment of Dose Limiting Toxicities (DLTs) (Initiation of study drug through 4 weeks)
• Phase 1 and 2 -Treatment-emergent Adverse Events (Initiation of study drug through 30 days after the last dose (up to approximately 24 months))
• Phase 2- Objective Response Rate (ORR) (Initiation from study drug until disease progression (up to approximately 24 months))

Sponsor

Recursion Pharmaceuticals Inc. · industry

All locations (6)

City of HopeRecruiting

Duarte, California, United States

Cleveland ClinicRecruiting

Cleveland, Ohio, United States

SCRI Oncology Partners - PPDSWithdrawn

Nashville, Tennessee, United States

START Mountain RegionRecruiting

West Valley City, Utah, United States

McGill University Health Centre (MUHC) - The MontrealRecruiting

Québec, Canada, Canada

Princess Margaret Cancer CentreRecruiting

Toronto, Ontario, Canada

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