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SHP2 Inhibitor BBP-398 in Combination With Nivolumab in Patients With Advanced Non-Small Cell Lung Cancer With a KRAS Mutation

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ClinicalTrials.gov Identifier: NCT05375084
Recruitment Status : Recruiting
First Posted : May 16, 2022
Last Update Posted : February 16, 2024
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Navire Pharma Inc., a BridgeBio company

Tracking Information
First Submitted Date  ICMJE May 10, 2022
First Posted Date  ICMJE May 16, 2022
Last Update Posted Date February 16, 2024
Actual Study Start Date  ICMJE October 20, 2022
Estimated Primary Completion Date July 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 10, 2022)
  • Phase 1a Dose Escalation: Assess safety, tolerability, and recommended phase 2 dose (RP2D) of BBP-398 in combination with nivolumab [ Time Frame: Completion of 1 Cycle (28 days) ]
  • Phase 1b Dose Expansion: Assess antitumor activity of BBP-398 in combination with nivolumab [ Time Frame: Completion of 1 Cycle (28 days) ]
    Anti-tumor activity will be defined by objective response rate (ORR) according to RECIST v1.1
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 10, 2022)
  • Assess preliminary antitumor activity of BBP-398 in combination with nivolumab [ Time Frame: Completion of 1 Cycle (28 days) ]
    Anti-tumor activity will be defined by objective response rate (ORR) [escalation], duration of response (DOR) and progression free survival (PFS), as defined by RECIST v1.1. and overall survival (OS) [both escalation and expansion]
  • Phase 1b Dose Expansion: Assess safety and tolerability of BBP-398 at the RP2D, in combination with nivolumab [ Time Frame: Completion of 1 Cycle (28 days) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SHP2 Inhibitor BBP-398 in Combination With Nivolumab in Patients With Advanced Non-Small Cell Lung Cancer With a KRAS Mutation
Official Title  ICMJE A Phase 1 Study of the SHP2 Inhibitor BBP-398 (Formerly Known as IACS-15509) in Combination With the Programmed Death Receptor-1 Blocking Antibody Nivolumab in Patients With Advanced Non-Small Cell Lung Cancer With a KRAS Mutation
Brief Summary This is a Phase 1 study of BBP-398, a SHP2 inhibitor, in combination with nivolumab, a PD-1 antibody, in patients with NSCLC with a KRAS mutation. The study involves 2 parts: Phase 1a Dose Escalation and Phase 1b Dose Expansion.
Detailed Description

The primary objective for Phase 1a Dose Escalation is to evaluate the safety, tolerability, and RP2D of BBP-398, a SHP2 inhibitor, when used in combination with nivolumab in patients with advanced NSCLC with a KRAS mutation who have failed standard of care treatment.

The primary objective for Phase 1b Dose Expansion is to evaluate the antitumor activity of BBP-398, as defined by the ORR (per investigator) according to RECIST v1.1, when used in combination with nivolumab in patients with advanced NSCLC with a KRAS mutation who have failed standard of care treatment.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Non Small Cell Lung Cancer
  • Solid Tumor
Intervention  ICMJE Drug: BBP-398 with nivolumab
BBP-398 administered orally once a day (QD); nivolumab administered intravenously every 4 weeks (Q4wks)
Study Arms  ICMJE
  • Experimental: Dose Escalation Level 1
    Level 1 oral capsules administered in combination with nivolumab
    Intervention: Drug: BBP-398 with nivolumab
  • Experimental: Dose Escalation Level 2
    Level 2 oral capsules administered in combination with nivolumab
    Intervention: Drug: BBP-398 with nivolumab
  • Experimental: Dose Escalation Level 3
    Level 3 oral capsules administered in combination with nivolumab
    Intervention: Drug: BBP-398 with nivolumab
  • Experimental: Dose Expansion
    RP2D defined dose. Oral capsules administered in combination with nivolumab
    Intervention: Drug: BBP-398 with nivolumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 10, 2022)		 45
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2025
Estimated Primary Completion Date July 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • Patients must have histologically documented, locally advanced and unresectable, or metastatic NSCLC with documentation of a KRAS mutation within the 1 year prior to screening.
  • Patients must have measurable disease by RECIST v1.1.
  • Patients must have a minimum life expectancy of >12 weeks after start of study treatment.
  • Patients must have progression or disease recurrence on or after at least one prior line of systemic therapy, which must include platinum-based doublet chemotherapy and anti-PD-(L)1 therapy.
  • Patients must have experienced progressive or recurrent disease occurring either during treatment or within 90 days after discontinuing anti-PD-(L)1 therapy.
  • Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.
  • Patients must have adequate organ function.

Key Exclusion Criteria:

  • Patients that have participated in an interventional clinical study within the last 4 weeks.
  • Patients that have received radiotherapy or proton therapy with a limited field of radiation for palliation within 1 week of the start of study treatment, OR radiation to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the start of study treatment.
  • Patients with known central nervous system (CNS) tumors or active CNS metastases.
  • Patients that have experienced progressive disease (PD) within the first 120 days of initiating treatment with an anti- PD-(L)1 agent (e.g., primary refractory).
  • Patients that have a history of allogenic bone marrow transplant.
  • Patients that have select known or suspected autoimmune disease.
  • Patients that have a condition requiring systemic treatment with either corticosteroids (>10 mg prednisone equivalent) or other immunosuppressive medication within 14 days of study start.
  • Patients that have received any live/attenuated vaccine within 30 days of first study treatment.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Navire Clinical Operations 650-391-9740 NAV1004ct.gov@bridgebio.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05375084
Other Study ID Numbers  ICMJE NAV-1004
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Navire Pharma Inc., a BridgeBio company
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Navire Pharma Inc., a BridgeBio company
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Bristol-Myers Squibb
Investigators  ICMJE Not Provided
PRS Account Navire Pharma Inc., a BridgeBio company
Verification Date February 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP