RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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). 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

Quick Facts

Study Start:2023-03-24
Study Completion:2027-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05827614

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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,
  2. * Evidence of oncogene amplification,
  3. * Availability of FFPE tumor tissue, archival or newly obtained,
  4. * Measurable disease as defined by RECIST Version 1.1,
  5. * Adequate hematologic function,
  6. * Adequate hepatic and renal function,
  7. * Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1,
  8. * Other inclusion criteria per study protocol.
  1. * Single agent arm: Prior exposure to CHK1 or WEE1 inhibitors,
  2. * BBI-355 combination with BBI-825 arm: Prior exposure to combination therapy of any RNR inhibitor plus CHK1/2 inhibitor,
  3. * Hematologic malignancies,
  4. * Primary CNS malignancy, leptomeningeal disease, or symptomatic active CNS metastases, with exceptions per study protocol,
  5. * Prior or concurrent malignancies, with exceptions per study protocol,
  6. * History of HBV, HCV, or HIV infection,
  7. * Clinically significant cardiac condition,
  8. * Active or history of interstitial lung disease (ILD) or pneumonitis, or history of ILD or pneumonitis requiring steroids or other immunosuppressive medications,
  9. * QTcF \> 470 msec,
  10. * Prior organ allograft transplantations or allogeneic peripheral blood stem cell/bone marrow transplantation,
  11. * Other exclusion criteria per study protocol.

Contacts and Locations

Study Contact

Angela Pietrofeso
CONTACT
16198211090
Clinicaltrials@boundlessbio.com
Rebecca Reynolds
CONTACT
16198211090
Clinicaltrials@boundlessbio.com

Principal Investigator

Robert Doebele, MD, PhD
STUDY_DIRECTOR
Boundless Bio

Study Locations (Sites)

UCLA Medical Center
Los Angeles, California, 90095
United States
Sarcoma Oncology
Santa Monica, California, 90403
United States
HealthONE
Denver, Colorado, 80218
United States
Florida Cancer Specialists
Lake Mary, Florida, 32746
United States
The University of Kansas
Fairway, Kansas, 66205
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
United States
START Midwest
Grand Rapids, Michigan, 49546
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
Medical University of South Carolina
Charleston, South Carolina, 29425
United States
SCRI Oncology Partners
Nashville, Tennessee, 37203
United States
MD Anderson Cancer Center
Houston, Texas, 77054
United States
NEXT Oncology - Dallas
Irving, Texas, 75039
United States
NEXT Oncology
San Antonio, Texas, 78229
United States
NEXT Oncology
Fairfax, Virginia, 22031
United States
University of Washington, Fred Hutchinson Cancer Center
Seattle, Washington, 98109
United States
University of Wisconsin
Madison, Wisconsin, 53792
United States

Collaborators and Investigators

Sponsor: Boundless Bio

  • Robert Doebele, MD, PhD, STUDY_DIRECTOR, Boundless Bio

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-24
Study Completion Date2027-03-31

Study Record Updates

Study Start Date2023-03-24
Study Completion Date2027-03-31

Terms related to this study

Keywords Provided by Researchers

  • ecDNA
  • extrachromosomal DNA
  • Amplification
  • Oncogene Amplification
  • Checkpoint kinase 1
  • CHK1
  • RNR
  • ribonucleotide reductase

Additional Relevant MeSH Terms

  • 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