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NCT Number: NCT06678659

A 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.

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Key information

Conditions

Unresectable Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Locally Advanced Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Metastatic Cancers Neoplasms Neoplasms by Histologic Type Relapsed/Refractory Lymphomas

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Princess Margaret Cancer Centre, Toronto, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

REC-1245

Drug

Oral

Primary outcomes

  1. 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

  2. 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

  3. Phase 2- Objective Response Rate (ORR)

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

    To assess tumor response

Secondary outcomes

  1. Phase 1- ORR

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

    To assess tumor response

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. Phase 1 - Maximum Plasma Concentration (Cmax)

    Time frame: Initiation of study drug through Week 9

    To characterize PK of REC-1245

  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

  10. Phase 1 - Plasma Concentration Before the Next Dose (Ctrough)

    Time frame: Initiation of study drug through Week 9

    To characterize PK of REC-1245

  11. Phase 1 - Area Under Plasma Concentration-time Curve (AUC)

    Time frame: Initiation of study drug through Week 9

    To characterize PK of REC-1245

Sponsors and collaborators

Lead sponsor

Recursion Pharmaceuticals Inc.

Industry

Registry information

Official study title

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

Acronym: DAHLIA

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Nov 7, 2024
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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