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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

NCT05827614 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2026-01-23

No results posted yet for this study

Summary

BBI-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.

Conditions

  • 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

Interventions

DRUG

BBI-355

Oral CHK1 inhibitor

DRUG

Erlotinib

EGFR Inhibitor

DRUG

Futibatinib

FGFR1-4 Inhibitor

DRUG

BBI-825

Oral RNR Inhibitor

Sponsors & Collaborators

  • Boundless Bio

    lead INDUSTRY

Principal Investigators

  • Robert Doebele, MD, PhD · Boundless Bio

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-24
Primary Completion
2026-09-30
Completion
2027-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05827614 on ClinicalTrials.gov