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, PK, 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 individuals will be enrolled in this open-label Phase 1/2 study, allocated 55 individuals in Phase 1 and 10-30 individual's 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
• Status Verified: 2024-11
• Study Start: 2024-11-05
• Study First Submitted QC: 2024-11-05
• Last Update Submitted: 2024-11-05
• Study First Posted: 2024-11-07
• Last Update Posted: 2024-11-07
• 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.

ECOG performance status ≤ 1 Measurable disease at baseline per RECIST 1.1 / Lugano criteria and documented by computed CT and / or MRI

Read More

Exclusion Criteria

• Received treatment with another RBM39 degrader Clinically significant gastrointestinal (GI) or GI malabsorption

Read More

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	Dose Confirmation
Phase 1b Dose #2	REC-1245	Dose #2 TBD

Primary Outcome Measures

Name	Time	Method
Phase 2- Objective Response Rate [ORR]	Initiation from study drug until disease progression [up to approximately 24 months]	To assess tumor response
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 1/2 -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

Secondary Outcome Measures

Name	Time	Method
Phase 1- Objective Response Rate [ORR]	Initiation from study drug until disease progression [up to approximately 24 months]	To assess tumor response
Phase 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 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 2 - Duration of SD	Initiation from study drug until disease progression as applicable [up to approximately 24 months]	To assess the anti-tumor activity
Phase 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 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 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 1/2 - maximum plasma concentration (Cmax)	Initiation of study drug through Week 9	To characterize PK of REC-1245
Phase 1/2 - time to reach maximum plasma concentration (Tmax)	Initiation of study drug through Week 9	To characterize PK of REC-1245
Phase 1/2 - plasma concentration before the next dose (Ctrough) and Area under plasma concentration-time c	Initiation of study drug through Week 9	To characterize PK of REC-1245

Trial Locations

Locations (1)

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