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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05827614
Recruitment Status : Recruiting
First Posted : April 25, 2023
Last Update Posted : May 9, 2023
Sponsor:
Information provided by (Responsible Party):
Boundless Bio

Study Description
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Brief Summary:
BBI-355 is an orally available, potent, and 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, non-randomized, 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.

Condition or disease Intervention/treatment Phase
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 Drug: BBI-355 Phase 1

Detailed Description:
BBI-355 will be administered orally every other day 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 47 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: BBI-355 single agent therapy dose escalation and expansion
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, First-in-Human, Dose-Escalation and Dose-Expansion, Phase 1/2 Study of BBI-355 and BBI-355 in Combination With Select Therapies in Subjects With Locally Advanced or Metastatic Solid Tumors With Oncogene Amplifications
Actual Study Start Date : March 24, 2023
Estimated Primary Completion Date : January 31, 2025
Estimated Study Completion Date : January 31, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Single Agent Therapy Dose Escalation
Single agent therapy BBI-355, administered orally every other day in 28-day cycles
 Drug: BBI-355
Oral CHK1 inhibitor
Experimental: Single Agent Therapy Dose Expansion
Single agent therapy BBI-355, administered orally every other day in 28-day cycles
 Drug: BBI-355
Oral CHK1 inhibitor


Outcome Measures
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Primary Outcome Measures :
  1. Frequency and severity of treatment emergent adverse events (TEAEs) of BBI-355 [ Time Frame: Start of Cycle 1 until 30 days following last dose (each cycle is 28 days) ]
    TEAEs will be assessed and severity assigned by using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.

  2. Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of BBI-355 [ Time Frame: Start of Cycle 1 until 30 days following last dose (each cycle is 28 days) ]
    The MTD and/or RP2D of BBI-355 will be determined.


Secondary Outcome Measures :
  1. Maximum observed plasma concentration (Cmax) of BBI-355 [ Time Frame: Start of Cycle 1 until Day 1 of last treatment cycle (each cycle is 28 days) ]
    Maximum observed plasma concentration (Cmax) of BBI-355 will be determined.

  2. Trough observed plasma concentration (Ctrough) of BBI-355 [ Time Frame: Start of Cycle 1 until Day 1 of last treatment cycle (each cycle is 28 days) ]
    Trough observed plasma concentration (Ctrough) of BBI-355 will be determined.

  3. Time to Cmax (Tmax) of BBI-355 [ Time Frame: Start of Cycle 1 until Day 1 of last treatment cycle (each cycle is 28 days) ]
    Time to Cmax (Tmax) of BBI-355 will be determined.

  4. Area under the concentration time curve (AUC) of BBI-355 [ Time Frame: Start of Cycle 1 until Day 1 of last treatment cycle (each cycle is 28 days) ]
    Area under the concentration time curve (AUC) of BBI-355 will be determined.

  5. Anti-tumor activity of BBI-355 [ Time Frame: 1-2 years: Start of Cycle 1 until documented disease progression or death (each cycle is 28 days) ]
    Tumor response will be determined by RECISTv1.1.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion 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,
  • 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.

Key Exclusion Criteria:

  • Prior exposure to CHK1 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05827614


Contacts
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Contact: Sara Weymer 16198211090 ClinicalDevelopment@boundlessbio.com
Contact: Rebecca Reynolds 16198211090 ClinicalDevelopment@boundlessbio.com

Locations
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United States, Michigan
START Midwest Recruiting
Grand Rapids, Michigan, United States, 49546
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77054
NEXT Oncology Recruiting
San Antonio, Texas, United States, 78229
United States, Virginia
NEXT Oncology Recruiting
Fairfax, Virginia, United States, 22031
Sponsors and Collaborators
Boundless Bio
Investigators
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Study Director: Klaus Wagner, MD, PhD Boundless Bio
More Information
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Publications:

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Responsible Party: Boundless Bio
ClinicalTrials.gov Identifier: NCT05827614    
Other Study ID Numbers: BBI-355-101
First Posted: April 25, 2023    Key Record Dates
Last Update Posted: May 9, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Boundless Bio:
ecDNA
extrachromosomal DNA
Amplification
 Oncogene Amplification
Checkpoint kinase 1
CHK1
Additional relevant MeSH terms:
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Lung Neoplasms
Endometrial Neoplasms
Squamous Cell Carcinoma of Head and Neck
Adenocarcinoma of Lung
Liposarcoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Squamous Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Adenocarcinoma
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Genital Diseases
Head and Neck Neoplasms
Uterine Neoplasms
Uterine Diseases
Neoplasms, Adipose Tissue
Neoplasms, Connective and Soft Tissue
Sarcoma