Übersicht

Eignung

Details zum Design

Arme & Interventionen

Ergebnismessungen

Studienzentren

Quelle: NCT06678659

Rekrutiert

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

Interventionsstudie

Phase 1/2

City of Hope

Sponsor: Recursion Pharmaceuticals

Zuletzt aktualisiert: 5. Dezember 2025
Hinweis - Die Informationen stammen aus öffentlichen Registern und spiegeln möglicherweise nicht die Echtzeitänderungen am lokalen Studienzentrum wider.

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.

Detaillierte Beschreibung anzeigen

Behandlungskategorie

Andere Medikamente

Erforderliche Mutationen

Keine

Studie gestartet

21. November 2024

Zuletzt vom Sponsor aktualisiert

5. Dezember 2025

Voraussichtlicher Abschluss

30. Oktober 2028

Studienkontakt

Eignung

Einschlusskriterien

* 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)

Ausschlusskriterien

* Received treatment with another RBM39 degrader

* Clinically significant gastrointestinal (GI) or GI malabsorption

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Design-Details

ZuteilungRandomized

InterventionsmodellSequential Assignment

MaskierungNone (Open Label)

Anzahl der Teilnehmer85

Arme & Interventionen

Arme

Interventionen

Typ: Experimental

Beschreibung: Dose Escalation

Interventionen:

REC-1245

Ergebnismessungen

Primäre Ergebnismessungen

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

Sekundäre Ergebnismessungen

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)