Study of the CHK1 Inhibitor BBI-355, an EcDNA-directed Therapy (ecDTx), in Subjects with Tumors with Oncogene Amplifications

Description

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). This is a first-in-human, open-label, 3-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 select therapies.

Conditions

Non-small Cell Lung Cancer, Non-Small Cell Lung Adenocarcinoma, Non-Small Cell Squamous Lung Cancer, Head and Neck Squamous Cell Carcinoma, Esophageal Cancer, Gastric Cancer, Breast Cancer, Bladder Cancer, Ovarian Cancer, Endometrial Cancer, Liposarcoma

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Study Overview

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Study Details

Study overview

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). This is a first-in-human, open-label, 3-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 select therapies.

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

Study of the CHK1 Inhibitor BBI-355, an EcDNA-directed Therapy (ecDTx), in Subjects with Tumors with Oncogene Amplifications

Condition
Non-small Cell Lung Cancer
Intervention / Treatment

-

Contacts and Locations

Los Angeles

UCLA Medical Center, Los Angeles, California, United States, 90095

Santa Monica

Sarcoma Oncology, Santa Monica, California, United States, 90403

Denver

HealthONE, Denver, Colorado, United States, 80218

Lake Mary

Florida Cancer Specialists, Lake Mary, Florida, United States, 32746

Fairway

The University of Kansas, Fairway, Kansas, United States, 66205

Boston

Dana Farber Cancer Institute, Boston, Massachusetts, United States, 02215

Grand Rapids

START Midwest, Grand Rapids, Michigan, United States, 49546

New York

Memorial Sloan Kettering Cancer Center, New York, New York, United States, 10065

Charleston

Medical University of South Carolina, Charleston, South Carolina, United States, 29425

Nashville

SCRI Oncology Partners, Nashville, Tennessee, United States, 37203

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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,
  • * Single agent arm: Evidence of oncogene amplification,
  • * BBI-355 combination with erlotinib arm: Evidence of amplification of wildtype EGFR,
  • * BBI-355 combination with futibatinib arm: Evidence of amplification of wildtype FGFR1, FGFR2, FGFR3, or FGFR4,
  • * 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.
  • * Well-known tumor activating oncogene mutations or fusions,
  • * Prior exposure to CHK1 inhibitors,
  • * BBI-355 combination with erlotinib arm: Prior exposure to EGFR inhibitors,
  • * BBI-355 combination with futibatinib arm: Prior exposure to FGFR inhibitors,
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Boundless Bio,

Klaus Wagner, MD, PhD, STUDY_DIRECTOR, Boundless Bio

Study Record Dates

2027-09-30