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

NCT06678659 · tracked via the Priya Life Science USA tracker

Sponsor

Recursion Pharmaceuticals Inc.

Phase

Phase 1/2

Started

2024-11-21

Last updated

2026-08-20

Condition(s) studied

UnresectableLocally AdvancedMetastatic CancersRelapsed/Refractory Lymphomas

Investigational drug(s) / intervention(s)

REC-1245

REC-1245: Oral

Study 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.

Eligibility

Sex

ALL

Min age

12 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Phase 1-Part 1A (Dose Finding)- Number of Participants With Dose Limiting Toxicities (DLTs) — Initiation of study drug through 4 weeks
To characterize the incidence of DLTs
Phase 1 and 2 - Number of Participants With a Treatment-emergent Adverse Event — 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

Trial sites (7)

Facility	City	Region	Status
City of Hope	Duarte	California	Recruiting
Sarcoma Oncology Research Center	Santa Monica	California	Recruiting
Cleveland Clinic	Cleveland	Ohio	Recruiting
SCRI Oncology Partners - PPDS	Nashville	Tennessee	Withdrawn
START Mountain Region	West Valley City	Utah	Recruiting
Princess Margaret Cancer Centre	Toronto	Ontario	Recruiting
McGill University Health Centre (MUHC) - The Montreal	Québec	Canada	Recruiting

More Recursion Pharmaceuticals Inc. trials in the USA

Evaluate REC-4881 in Participants With Familial Adenomatous Polyposis (FAP) Recruiting

REC-7735 in Participants With Solid Tumors Recruiting

Other trials for the same condition

BEACON-1: Study of AVZO-103 as a Single Agent and in Combination Therapy in Patients With Locally Advanced or Metastatic Urothelial Cancer or Other Solid Tumors (AVZO-103-1001) Recruiting

AVENTINE-1: Study of AVZO-1418 as a Single Agent and in Combination Therapy in Patients With Locally Advanced or Metastatic Solid Tumors (AVZO-1418-1001) Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06678659 on ClinicalTrials.gov ↗ ← All trials in the USA