Recruiting
Phase 1
Phase 2

REC-1245

Sponsor:

Recursion Pharmaceuticals Inc.

Code:

NCT06678659

Conditions

Unresectable

Locally Advanced

Metastatic Cancers

Relapsed/Refractory Lymphomas

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

Interventions

REC-1245

Study Details

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

Study ID

NCT06678659

Start date

Nov 21, 2024

Status verified date

Aug, 2026

Completion date

Oct 30, 2028

Anticipated

Primary completion date

Oct 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

170 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Phase 1a

Dose Finding

experimental: Phase 1b Cohort A

experimental: Phase 1b Cohort B

experimental: Phase 1b Cohort C

experimental: Phase 1b Cohort D

experimental: Phase 2 Cohort 1 Dose #1

experimental: Phase 2 Cohort 1 Dose #2

experimental: Phase 2 Cohort 2 Dose #1

experimental: Phase 2 Cohort 2 Dose #2

Interventions

REC-1245

Oral

Primary outcome measure

  • Phase 1-Part 1A (Dose Finding)- Number of Participants With Dose Limiting Toxicities (DLTs) [ Time Frame: Initiation of study drug through 4 weeks ]
  • Phase 1 and 2 - Number of Participants With a Treatment-emergent Adverse Event [ Time Frame: Initiation of study drug through 30 days after the last dose (up to approximately 24 months) ]
  • Phase 2- Objective Response Rate (ORR) [ Time Frame: Initiation from study drug until disease progression (up to approximately 24 months) ]

Central Contacts and Locations

Locations

City of Hope

Recruiting

Duarte, California, United States, 91010

Contacts

Mihae Song

877-467-3411misong@coh.org

Sarcoma Oncology Research Center

Recruiting

Santa Monica, California, United States, 90403

Contacts

Victoria Chua

310-552-9999chua@sarcomaonology.com

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Jessica Grenbenc

216-444-7923canceranswer@ccf.org

START Mountain Region

Recruiting

West Valley City, Utah, United States, 84119

Contacts

Marie Asay

801-907-4750marie.asay@startresearch.com

Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G 1X6

Contacts

Anh Nguyen

416-946-4501anh.nguyen2@uhn.ca

McGill University Health Centre (MUHC) - The Montreal

Recruiting

Québec, Canada, H4A3J1

Contacts

Phuong-nam Nguyen

5149341934Phuong-nam.Nguyen@muhc.mcgill.ca

More Information

Sponsor

Recursion Pharmaceuticals Inc.

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

Keywords

  • RBM39
  • Cancer
  • Refractory Lymphomas
  • Metastatic Cancers

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Recursion Pharmaceuticals Inc. on 2026-08-20.