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Trial record 1 of 1 for:    NCT05375084
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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 : May 24, 2022
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Navire Pharma Inc., a BridgeBio company

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Estimated Study Start Date : May 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

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)




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) ]


Information from the National Library of Medicine

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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:

  • 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.

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
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Contact: Kunal Shah, PharmD Clinical Operations Lead 408-338-7842 kunal.shah@bridgebio.com
Contact: Hiywot Takkele Sr. Director, Clinical Operations 501-387-0916 Hiywot.takkele@qedtx.com

Locations
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United States, Virginia
NEXT Oncology Recruiting
Fairfax, Virginia, United States, 22031
Sponsors and Collaborators
Navire Pharma Inc., a BridgeBio company
Bristol-Myers Squibb
Investigators
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Study Director: Susanna Wen MsM, PhD Navire Pharma Inc., a BridgeBio company
Study Director: Lauren Wood MD Navire Pharma Inc., a BridgeBio company
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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: May 24, 2022
Last Verified: May 2022

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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 Navire Pharma Inc., a BridgeBio company:
KRAS mutation
MAPK-pathway alterations
NSCLC
SHP2
Additional relevant MeSH terms:
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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