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

Description

This is a multi-center, open-label study to investigate the safety, tolerability, PK, 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 individuals will be enrolled in this open-label Phase 1/2 study, allocated 55 individuals in Phase 1 and 10-30 individual's 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.

Trial 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. ECOG performance status ≤ 1 Measurable disease at baseline per RECIST 1.1 / Lugano criteria and documented by computed CT and / or MRI Exclusion Criteria: * Received treatment with another RBM39 degrader Clinically significant gastrointestinal (GI) or GI malabsorption

Study Info

Interventions

Locations Recruiting

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