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

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: 170 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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170 participants in 9 patient groups

Phase 1a

Experimental group

Description:

Dose Finding

Treatment:

Drug: REC-1245

Phase 1b Cohort A

Experimental group

Treatment:

Drug: REC-1245

Phase 1b Cohort B

Experimental group

Treatment:

Drug: REC-1245

Phase 1b Cohort C

Experimental group

Treatment:

Drug: REC-1245

Phase 1b Cohort D

Experimental group

Treatment:

Drug: REC-1245

Phase 2 Cohort 1 Dose #1

Experimental group

Treatment:

Drug: REC-1245

Phase 2 Cohort 1 Dose #2

Experimental group

Treatment:

Drug: REC-1245

Phase 2 Cohort 2 Dose #1

Experimental group

Treatment:

Drug: REC-1245

Phase 2 Cohort 2 Dose #2

Experimental group

Treatment:

Drug: REC-1245