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

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ClinicalTrials.gov Identifier: NCT05827614
Recruitment Status : Recruiting
First Posted : April 25, 2023
Last Update Posted : February 28, 2024
Sponsor:
Information provided by (Responsible Party):
Boundless Bio

Study Description
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Brief 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). 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.

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 Drug: Erlotinib Drug: Futibatinib Phase 1

Detailed Description:
BBI-355 is 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: BBI-355 single agent dose escalation and expansion, and BBI-355 dose escalation in combination with select targeted therapies.
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 24, 2023
Estimated Primary Completion Date : September 30, 2026
Estimated Study Completion Date : September 30, 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Single Agent Dose Escalation
Single agent BBI-355, administered orally in 28-day cycles
 Drug: BBI-355
Oral CHK1 inhibitor
Experimental: Single Agent Dose Expansion
Single agent BBI-355, administered orally in 28-day cycles
 Drug: BBI-355
Oral CHK1 inhibitor
Experimental: Dose Escalation in Combination with EGFR Inhibitor
Combination therapy of BBI-355 and EGFR inhibitor erlotinib, administered orally in 28-day cycles.
 Drug: BBI-355
Oral CHK1 inhibitor

Drug: Erlotinib
EGFR Inhibitor
Experimental: Dose Escalation in Combination with FGFR Inhibitor
Combination therapy of BBI-355 and FGFR1-4 inhibitor futibatinib, administered orally in 28-day cycles.
 Drug: BBI-355
Oral CHK1 inhibitor

Drug: Futibatinib
FGFR1-4 Inhibitor


Outcome Measures
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Primary Outcome Measures :
  1. Frequency and severity of treatment emergent adverse events (TEAEs) of BBI-355 as a single agent and in combination with each of the following agents: erlotinib or futibatinib [ 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 as a single agent and in combination with either erlotinib or futibatinib [ 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 as a single agent and in combination with either erlotinib or futibatinib, will be determined.


Secondary Outcome Measures :
  1. Maximum observed plasma concentration (Cmax) of BBI-355, erlotinib, and futibatinib [ 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, erlotinib, and futibatinib will be determined.

  2. Trough observed plasma concentration (Ctrough) of BBI-355, erlotinib, and futibatinib [ 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, erlotinib, and futibatinib will be determined.

  3. Time to Cmax (Tmax) of BBI-355, erlotinib, and futibatinib [ 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, erlotinib, and futibatinib will be determined.

  4. Area under the concentration time curve (AUC) of BBI-355, erlotinib, and futibatinib [ 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, erlotinib, and futibatinib will be determined.

  5. Anti-tumor activity of BBI-355 as a single agent and in combination with either erlotinib or futibatinib [ 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,
  • 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.

Key Exclusion Criteria:

  • 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.
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, California
Sarcoma Oncology Recruiting
Santa Monica, California, United States, 90403
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: February 28, 2024
Last Verified: February 2024
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
EGFR amplification
FGFR1 amplification
FGFR2 amplification
FGFR3 amplification
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
Erlotinib Hydrochloride