Calendario›BOLD›BBI-355 · POTENTIATE

BBI-355 · POTENTIATE

Study of the CHK1 Inhibitor BBI-355, an ecDNA-directed Therapy (ecDTx), and the RNR Inhibitor BBI-825, in Subjects With Tumors With Oncogene Amplifications

Ensayo de Boundless Bio, Inc. en Triple Negative Breast Cancer (TNBC) · High Grade Serous Ovarian Carcinoma · High Grade Endometrial Carcinoma · Anogenital Cancer · Head and Neck (HNSCC) · Cutaneous Squamous Cell Carcinoma (CSCC) · Cervical Squamous Cell Carcinoma · ER+ Breast Cancer · Leiomyosarcoma (LMS) · Undifferentiated Pleomorphic Sarcoma (UPS) · Pancreatic Cancer Metastatic · Small Cell Lung Cancer (del registro, en inglés).

Más ensayos de: Cáncer de mama triple negativo · Cáncer de páncreas metastásico · Cáncer de pulmón microcítico.

Fase

Fase 1

Estado

Interrumpido

Participantes

85

previstos

Centros

16

Fin del objetivo primario

mar 2026

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en mar 2023.

Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «Decision was made to halt the study based on overall clinical experience and market considerations. This decision was not driven by any safety signal.».

Qué mide

Frequency and severity of treatment emergent adverse events (TEAEs) of BBI-355 as a single agent and in combination with each of the following agents: erlotinib, futibatinib, or BBI-825 (Start of Cycle 1 until 30 days following last dose (each cycle is 28 days)) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroBBI-355 is an oral, potent, selective checkpoint kinase 1 (or CHK1) small molecule inhibitor in development as an ecDNA (extrachromosomal DNA) directed therapy (ecDTx). BBI-825 is an oral, potent, selective ribonucleotide reductase (or RNR) small molecule inhibitor. This is a first-in-human, open-label, 2-part, Phase 1/2 study to determine the safety profile and identify the maximum tolerated dose and recommended Phase 2 dose of BBI-355 administered as a single agent or in combination with BBI-825 or other select therapies.

Más ensayos de BOLD

Todos los de BOLD, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT05827614), actualizada en ago 2026.