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

Phase 1

Recruiting

• Conditions: Unresectable; Locally Advanced; Metastatic Cancers; Relapsed/Refractory Lymphomas
• Interventions: Drug: REC-1245

• Registration Number: NCT06678659
• Lead Sponsor: Recursion Pharmaceuticals Inc.

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

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.

Study Timeline

• Study First Submitted: 2024-10-29
• Study First Submitted QC: 2024-11-05
• Study First Posted: 2024-11-07
• Study Start: 2024-11-21
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-18
• Last Update Posted: 2025-09-23
• Primary Completion: 2028-10-30
• Study Completion: 2028-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 85

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

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Phase 1a	REC-1245	Dose Escalation
Phase 1b Dose #1	REC-1245	-
Phase 1b Dose #2	REC-1245	-
Phase 2	REC-1245	At recommended Phase 2 dose (RP2D)

Primary Outcome Measures

Name	Time	Method
Phase 1-Part 1A (Dose Finding)- Assessment of Dose Limiting Toxicities (DLTs)	Initiation of study drug through 4 weeks	To characterize the incidence of DLTs
Phase 1 and 2 -Treatment-emergent Adverse Events	Initiation of study drug through 30 days after the last dose (up to approximately 24 months)	To characterize the incidence of treatment emergent adverse events
Phase 2- Objective Response Rate (ORR)	Initiation from study drug until disease progression (up to approximately 24 months)	To assess tumor response

Secondary Outcome Measures

Name	Time	Method
Phase 1- ORR	Initiation from study drug until disease progression (up to approximately 24 months)	To assess tumor response
Phase 1 - Time to Reach Maximum Plasma Concentration (Tmax)	Initiation of study drug through Week 9	To characterize PK of REC-1245
Phase 1 - Plasma Concentration Before the Next Dose (Ctrough)	Initiation of study drug through Week 9	To characterize PK of REC-1245
Phase 1 - Area Under Plasma Concentration-time Curve (AUC)	Initiation of study drug through Week 9	To characterize PK of REC-1245
Phase 1 and 2- Disease Control Rate (DCR)	Initiation from study drug until disease progression as applicable (up to approximately 24 months)	To assess the anti-tumor activity
Phase 1 and 2 - Duration of Stable Disease (SD)	Initiation from study drug until disease progression as applicable (up to approximately 24 months)	To assess the anti-tumor activity
Phase 1 and 2 - Time to Response (TTR)	Initiation from study drug until disease progression as applicable (up to approximately 24 months)	To assess the anti-tumor activity
Phase 1 and 2 - Progression Free Survival (PFS)	Initiation from study drug until disease progression as applicable (up to approximately 24 months)	To assess the anti-tumor activity
Phase 1 and 2 - Duration of Response (DOR)	Initiation from study drug until disease progression as applicable (up to approximately 24 months)	To assess the anti-tumor activity
Phase 1 and 2 - Overall Survival (OS)	Initiation from study drug until disease progression as applicable (up to approximately 24 months)	To assess the anti-tumor activity
Phase 1 - Maximum Plasma Concentration (Cmax)	Initiation of study drug through Week 9	To characterize PK of REC-1245

Trial Locations

Locations (6)

Princess Margaret Cancer Centre; 🇨🇦 Toronto, Ontario, Canada

City of Hope; 🇺🇸 Duarte, California, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

SCRI Oncology Partners - PPDS; 🇺🇸 Nashville, Tennessee, United States

START Mountain Region; 🇺🇸 West Valley City, Utah, United States

McGill University Health Centre (MUHC) - The Montreal; 🇨🇦 Québec, Canada