RecruitingPhase 1/2

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

United States, Canada170 participantsStarted 2024-11-21

Plain-language 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.

Who can participate

Age range12 Years

SexALL

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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

What they're measuring

Phase 1-Part 1A (Dose Finding)- Number of Participants With Dose Limiting Toxicities (DLTs)

Timeframe: Initiation of study drug through 4 weeks

Phase 1 and 2 - Number of Participants With a Treatment-emergent Adverse Event

Timeframe: Initiation of study drug through 30 days after the last dose (up to approximately 24 months)

Phase 2- Objective Response Rate (ORR)

Timeframe: Initiation from study drug until disease progression (up to approximately 24 months)

Trial details

NCT IDNCT06678659

SponsorRecursion Pharmaceuticals Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-10-30

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