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

Phase 2RecruitingNCT06678659

Recursion Pharmaceuticals Inc.85 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Unresectable Locally Advanced Metastatic Cancers Relapsed/Refractory Lymphomas

Interventions

REC-1245DRUG

Oral

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (6)

City of Hope

Duarte, California, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, United States

RECRUITING

SCRI Oncology Partners - PPDS

Nashville, Tennessee, United States

Outcomes

Primary Outcomes

Phase 1-Part 1A (Dose Finding)- Assessment of Dose Limiting Toxicities (DLTs)

To characterize the incidence of DLTs

Time frame: Initiation of study drug through 4 weeks

Phase 1 and 2 -Treatment-emergent Adverse Events

To characterize the incidence of treatment emergent adverse events

Time frame: Initiation of study drug through 30 days after the last dose (up to approximately 24 months)

Phase 2- Objective Response Rate (ORR)

To assess tumor response

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

Secondary Outcomes

Phase 1- ORR

To assess tumor response

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

Phase 1 and 2- Disease Control Rate (DCR)

To assess the anti-tumor activity

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

Phase 1 and 2 - Duration of Response (DOR)

To assess the anti-tumor activity

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

Phase 1 and 2 - Duration of Stable Disease (SD)

To assess the anti-tumor activity

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.