An Open-Label, Multicenter, First-in-Human, Dose-Escalation and Dose-Expansion, Phase I/II 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 Identifier:
BBI-355-101
CT.gov Identifier:
NCT05827614
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Terminated/Withdrawn

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Study Summary

To evaluate BBI-355 in patients with oncogene amplified cancers

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.

To evaluate BBI-355 and BBI-825 as a combination therapy in the POTENTIATE clinical trial.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Breast Cancers
  • Ovarian
  • Endometrial
  • Unspecified Cancer
  • Head & Neck
  • Squamous Cell Carcinoma
  • Cervical cancer
  • Soft Tissue Sarcoma
  • Sarcoma
  • Pancreas
  • Small Cell Lung
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I/II
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: Single Agent Dose Escalation
    • Read More
  • Drug: Experimental: Single Agent Dose Expansion
  • Drug: Experimental: Dose Escalation in Combination with EGFR Inhibitor
  • Drug: Drug: Erlotinib
  • Drug: Experimental: Dose Escalation in Combination with FGFR Inhibitor
  • Drug: Drug: Futibatinib
  • Drug: Experimental: Dose Escalation in Combination with RNR Inhibitor
  • Drug: Drug: BBI-825
  • Drug: Part 1: BBI-355 single agent dose escalation and expansion in cancer patients with oncogene amplification.
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Terminated/Withdrawn

    Requirements information
    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.
    Exclusion criteria
    • 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.

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Midwest
    Grand Rapids, MI, United States, 49546
    Investigator
    Manish Sharma
    Status
    Recruiting
    Condition(s) Treated at Site
    Breast Cancers
    Ovarian
    Endometrial
    Unspecified Cancer
    Head & Neck
    Squamous Cell Carcinoma
    Cervical cancer
    Soft Tissue Sarcoma
    Sarcoma
    Pancreas
    Small Cell Lung