This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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: 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

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Solid Tumor Drug: BBP-398 with nivolumab Phase 1

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : October 20, 2022
Estimated Primary Completion Date : July 2024
Estimated Study Completion Date : January 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Nivolumab

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Dose Escalation Level 1
Level 1 oral capsules administered in combination with nivolumab
 Drug: BBP-398 with nivolumab
BBP-398 administered orally once a day (QD); nivolumab administered intravenously every 4 weeks (Q4wks)
Experimental: Dose Escalation Level 2
Level 2 oral capsules administered in combination with nivolumab
 Drug: BBP-398 with nivolumab
BBP-398 administered orally once a day (QD); nivolumab administered intravenously every 4 weeks (Q4wks)
Experimental: Dose Escalation Level 3
Level 3 oral capsules administered in combination with nivolumab
 Drug: BBP-398 with nivolumab
BBP-398 administered orally once a day (QD); nivolumab administered intravenously every 4 weeks (Q4wks)
Experimental: Dose Expansion
RP2D defined dose. Oral capsules administered in combination with nivolumab
 Drug: BBP-398 with nivolumab
BBP-398 administered orally once a day (QD); nivolumab administered intravenously every 4 weeks (Q4wks)


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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) ]
  2. 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


Secondary Outcome Measures :
  1. 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]

  2. 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) ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT05375084


Contacts
Layout table for location contacts
Contact: Navire Clinical Operations 650-391-9740 NAV1004ct.gov@bridgebio.com

Locations
Layout table for location information
United States, Arkansas
Highlands Oncology Recruiting
Springdale, Arkansas, United States, 72762
Contact: Allie Clemons    479-872-8130    research@hogonc.com   
Principal Investigator: Eric S Schaefer, MD         
United States, California
Scripps Clinic Torrey Pines Recruiting
La Jolla, California, United States, 92037
Contact: Kiley Borchard, CCRC       crs_leadership_research@scrippshealth.org   
Principal Investigator: Michael Kosty, MD         
Providence Medical Foundation Recruiting
Santa Rosa, California, United States, 95403
Contact: Tracy Foster    707-521-3830    tracy.foster@stjoe.org   
Principal Investigator: Ian Anderson, MD         
United States, Florida
Memorial Regional Hospital (Memorial Cancer Institute) Recruiting
Hollywood, Florida, United States, 33021
Contact: Tamara Quintana    954-265-4325    lraez@mhs.net   
Contact: Milton Sanchez         
Principal Investigator: Luis E Raez, MD         
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Eduardo Galvez    813-745-4673    Eduardo.Galvez@moffitt.org   
Principal Investigator: Bruna Pellini, MD         
United States, Maryland
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center Recruiting
Baltimore, Maryland, United States, 21224
Contact: Kayla Eck    410-955-7458    kmarron1@jhmi.edu   
Principal Investigator: Kristen Marrone, MD         
United States, Michigan
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14203
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Jessica Grebenc    216-444-7923    canceranswer@ccf.og   
Principal Investigator: Nathan Pennell, MD, PhD         
United States, Oregon
Providence Portland Medical Center Recruiting
Portland, Oregon, United States, 97213
Contact       CanRsrchStudies@providence.org   
Principal Investigator: Rachel Sanborn, MD         
United States, Pennsylvania
University of Pennsylvania (Abramson Cancer Center) Recruiting
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
Medical University of South Carolina (MUSC) - Hollings Cancer Center Recruiting
Charleston, South Carolina, United States, 29425
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Lamiae Sahnoune    832-729-2342    Lsahnoune@mdanderson.org   
Principal Investigator: Marcelo V Negrao         
Millennium Research and Clinical Development Recruiting
Houston, Texas, United States, 77090
United States, Virginia
NEXT Oncology Recruiting
Fairfax, Virginia, United States, 22031
Contact: Blake Patterson    703-783-4510    bpatterson@nextoncology.com   
Principal Investigator: Alex Spira         
Sponsors and Collaborators
Navire Pharma Inc., a BridgeBio company
Bristol-Myers Squibb
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Navire Pharma Inc., a BridgeBio company
ClinicalTrials.gov Identifier: NCT05375084    
Other Study ID Numbers: NAV-1004
First Posted: May 16, 2022    Key Record Dates
Last Update Posted: February 16, 2024
Last Verified: February 2024

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Navire Pharma Inc., a BridgeBio company:
KRAS mutation
MAPK-pathway alterations
NSCLC
SHP2
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
 Carcinoma, Bronchogenic
Bronchial Neoplasms
Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action