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

Recursion Pharmaceuticals

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Locally Advanced; Metastatic Cancers; Unresectable; Relapsed/Refractory Lymphomas

Treatments: Drug: REC-1245

Study type: Interventional

Funder types: Industry

Identifiers

NCT06678659

REC-1245-101

Details and patient eligibility

About

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.

Full description

Approximately 85 participants will be enrolled in this open-label Phase 1/2 study, allocated 55 participants in Phase 1 and 10-30 participants in Phase 2. 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.

Enrollment: 85 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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85 participants in 4 patient groups

Phase 1a

Experimental group

Description:

Dose Escalation

Treatment:

Drug: REC-1245

Phase 1b Dose #1

Experimental group

Treatment:

Drug: REC-1245

Phase 1b Dose #2

Experimental group

Treatment:

Drug: REC-1245

Phase 2

Experimental group

Description:

At recommended Phase 2 dose (RP2D)

Treatment:

Drug: REC-1245