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

August 18, 2026 updated by: Recursion Pharmaceuticals Inc.

A Phase 1 / 2, Open-Label Study of REC-1245 in Participants With Unresectable, Locally Advanced, or Metastatic Cancer

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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 Type

Interventional

Enrollment (Estimated)

170

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Québec, Canada, H4A3J1
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X6
        • Recruiting
        • Princess Margaret Cancer Centre
        • Contact:
  • United States
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope
        • Contact:
      • Santa Monica, California, United States, 90403
        • Recruiting
        • Sarcoma Oncology Research Center
        • Contact:
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic
        • Contact:
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Withdrawn
        • SCRI Oncology Partners - PPDS
    • Utah
      • West Valley City, Utah, United States, 84119

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phase 1a
Dose Finding
Drug: REC-1245
Oral
Experimental: Phase 1b Cohort A
Drug: REC-1245
Oral
Experimental: Phase 1b Cohort B
Drug: REC-1245
Oral
Experimental: Phase 1b Cohort C
Drug: REC-1245
Oral
Experimental: Phase 1b Cohort D
Drug: REC-1245
Oral
Experimental: Phase 2 Cohort 1 Dose #1
Drug: REC-1245
Oral
Experimental: Phase 2 Cohort 1 Dose #2
Drug: REC-1245
Oral
Experimental: Phase 2 Cohort 2 Dose #1
Drug: REC-1245
Oral
Experimental: Phase 2 Cohort 2 Dose #2
Drug: REC-1245
Oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase 2- Objective Response Rate (ORR)
Time Frame: Initiation from study drug until disease progression (up to approximately 24 months)
To assess tumor response
Initiation from study drug until disease progression (up to approximately 24 months)
Phase 1-Part 1A (Dose Finding)- Number of Participants With Dose Limiting Toxicities (DLTs)
Time Frame: Initiation of study drug through 4 weeks
To characterize the incidence of DLTs
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)
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)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Recursion Pharmaceuticals Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 21, 2024

Primary Completion (Estimated)

October 30, 2028

Study Completion (Estimated)

October 30, 2028

Study Registration Dates

First Submitted

October 29, 2024

First Submitted That Met QC Criteria

November 5, 2024

First Posted (Actual)

November 7, 2024

Study Record Updates

Last Update Posted (Actual)

August 20, 2026

Last Update Submitted That Met QC Criteria

August 18, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC-1245-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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