Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
study ends around

Description

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.

Official Title

An Open-Label, Multicenter, First-in-Human, Dose-Escalation and Dose-Expansion, Phase 1/2 Study of BBI-355 and BBI-355 in Combination With Select Targeted Therapies in Subjects With Locally Advanced or Metastatic Solid Tumors With Oncogene Amplifications

Details

BBI-355 and BBI-825 are administered orally in various dosing schedules to subjects with locally advanced or metastatic non-resectable solid tumors harboring oncogene amplifications, whose disease has progressed despite all standard therapies or for whom no further standard or clinically acceptable therapy exists.

Keywords

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, ecDNA, extrachromosomal DNA, Amplification, Oncogene Amplification, Checkpoint kinase 1, CHK1, RNR, ribonucleotide reductase, Carcinoma, Breast Neoplasms, Squamous Cell Carcinoma, Small Cell Lung Carcinoma, Triple Negative Breast Neoplasms, Endometrial Neoplasms, Leiomyosarcoma, Malignant Fibrous Histiocytoma, Erlotinib Hydrochloride, Futibatinib, BBI-355, Erlotinib, BBI-825

Eligibility

You can join if…

Open to people ages 18 years and up

  • Locally advanced or metastatic non-resectable solid tumors, whose disease has progressed despite all standard therapies or for whom no further standard or clinically acceptable therapy exists,
  • Evidence of oncogene amplification,
  • Availability of FFPE tumor tissue, archival or newly obtained,
  • Measurable disease as defined by RECIST Version 1.1,
  • Adequate hematologic function,
  • Adequate hepatic and renal function,
  • Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1,
  • Other inclusion criteria per study protocol.

You CAN'T join if...

  • Single agent arm: Prior exposure to CHK1 or WEE1 inhibitors,
  • BBI-355 combination with BBI-825 arm: Prior exposure to combination therapy of any RNR inhibitor plus CHK1/2 inhibitor,
  • Hematologic malignancies,
  • Primary CNS malignancy, leptomeningeal disease, or symptomatic active CNS metastases, with exceptions per study protocol,
  • Prior or concurrent malignancies, with exceptions per study protocol,
  • History of HBV, HCV, or HIV infection,
  • Clinically significant cardiac condition,
  • Active or history of interstitial lung disease (ILD) or pneumonitis, or history of ILD or pneumonitis requiring steroids or other immunosuppressive medications,
  • QTcF > 470 msec,
  • Prior organ allograft transplantations or allogeneic peripheral blood stem cell/bone marrow transplantation,
  • Other exclusion criteria per study protocol.

Locations

  • UCLA Medical Center in progress, not accepting new patients
    Los Angeles California 90095 United States
  • Sarcoma Oncology in progress, not accepting new patients
    Santa Monica California 90403 United States
  • HealthONE accepting new patients
    Denver Colorado 80218 United States
  • University of Washington, Fred Hutchinson Cancer Center accepting new patients
    Seattle Washington 98109 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Boundless Bio
ID
NCT05827614
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 127 study participants
Last Updated