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

NCT06678659 | Recruiting Phase 1 FDA Drug

• 1 other identifier: REC-1245-101
• Study Type: interventional
• Target: 85
• Locations: 2 countries
• Sites: 6

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.

Conditions

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

Keywords

RBM39; Cancer; Refractory Lymphomas; Metastatic Cancers

Outcome Measures

Primary Outcomes (3)

• Phase 1-Part 1A (Dose Finding)- Assessment of Dose Limiting Toxicities (DLTs)

  To characterize the incidence of DLTs

  Initiation of study drug through 4 weeks

• Phase 1 and 2 -Treatment-emergent Adverse Events

  To characterize the incidence of 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)

  To assess tumor response

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

Secondary Outcomes (11)

• Phase 1- ORR

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

• Phase 1 and 2- Disease Control Rate (DCR)

  Initiation from study drug until disease progression as applicable (up to approximately 24 months)

• Phase 1 and 2 - Duration of Response (DOR)

  Initiation from study drug until disease progression as applicable (up to approximately 24 months)

• Phase 1 and 2 - Duration of Stable Disease (SD)

  Initiation from study drug until disease progression as applicable (up to approximately 24 months)

• Phase 1 and 2 - Time to Response (TTR)

  Initiation from study drug until disease progression as applicable (up to approximately 24 months)

Study Arms (4)

Phase 1a

EXPERIMENTAL

Dose Escalation

Drug: REC-1245

Phase 1b Dose #1

EXPERIMENTAL

Drug: REC-1245

Phase 1b Dose #2

EXPERIMENTAL

Drug: REC-1245

Phase 2

EXPERIMENTAL

At recommended Phase 2 dose (RP2D)

Drug: REC-1245

Interventions

REC-1245 DRUG

Oral

Phase 1a; Phase 1b Dose #1; Phase 1b Dose #2; Phase 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Recursion Pharmaceuticals Inc.: lead

Study Sites (6)

City of Hope

Duarte, California, 91010, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

SCRI Oncology Partners - PPDS

Nashville, Tennessee, 37203, United States

WITHDRAWN

START Mountain Region

West Valley City, Utah, 84119, United States

RECRUITING

McGill University Health Centre (MUHC) - The Montreal

Québec, Canada, H4A3J1, Canada

RECRUITING

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 1X6, Canada

RECRUITING

MeSH Terms

Conditions

Neoplasms; Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: "Phase 1a: Dose Escalation Phase 1b: Randomized Phase 2: Non-Randomized"

Study Record Dates

• First Submitted: October 29, 2024
• First Posted: November 7, 2024
• Study Start: November 21, 2024
• Primary Completion (Estimated): October 30, 2028
• Study Completion (Estimated): October 30, 2028
• Last Updated: December 5, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (4); CA (2)