Overview

Eligibility

Design Details

Arms & Interventions

Outcome Measures

Trial Sites

Source: NCT06678659

Recruiting

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

Interventional

Phase 1/2

City of Hope

Sponsor: Recursion Pharmaceuticals

Last Updated: December 5, 2025
Notice- Information is sourced from public registries and may not reflect real-time changes at the local site.

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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Treatment Category

Other Drugs

Required Mutations

None

Trial Started

November 21, 2024

Last Updated by Sponsor

December 5, 2025

Estimated Completion

October 30, 2028

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Eligibility

Inclusion Criteria

* 18 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)

Exclusion Criteria

* Received treatment with another RBM39 degrader

* Clinically significant gastrointestinal (GI) or GI malabsorption

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Design Details

AllocationRandomized

Intervention ModelSequential Assignment

MaskingNone (Open Label)

Number to Enroll85

Arms & Interventions

Arms

Interventions

Type: Experimental

Description: Dose Escalation

Interventions:

REC-1245

Outcome Measures

Primary Outcome Measures

Phase 1-Part 1A (Dose Finding)- Assessment of Dose Limiting Toxicities (DLTs)Initiation of study drug through 4 weeks

To characterize the incidence of DLTs

Phase 1 and 2 -Treatment-emergent Adverse EventsInitiation 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

Secondary Outcome Measures

Phase 1- ORRInitiation from study drug until disease progression (up to approximately 24 months)

To assess tumor response

Phase 1 and 2- Disease Control Rate (DCR)Initiation from study drug until disease progression as applicable (up to approximately 24 months)