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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

Primary Purpose

Non Small Cell Lung Cancer, Solid Tumor

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

BBP-398 with nivolumab

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring KRAS mutation, MAPK-pathway alterations, NSCLC, SHP2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Highlands OncologyRecruiting
Scripps Clinic Torrey PinesRecruiting
Providence Medical FoundationRecruiting
Memorial Regional Hospital (Memorial Cancer Institute)Recruiting
Moffitt Cancer CenterRecruiting
Cleveland ClinicRecruiting
Providence Portland Medical CenterRecruiting
University of Pennsylvania (Abramson Cancer Center)Recruiting
MD Anderson Cancer CenterRecruiting
NEXT OncologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Dose Escalation Level 1

Dose Escalation Level 2

Dose Escalation Level 3

Dose Expansion

Arm Description

Level 1 oral capsules administered in combination with nivolumab

Level 2 oral capsules administered in combination with nivolumab

Level 3 oral capsules administered in combination with nivolumab

RP2D defined dose. Oral capsules administered in combination with nivolumab

Outcomes

Primary Outcome Measures

Phase 1a Dose Escalation: Assess safety, tolerability, and recommended phase 2 dose (RP2D) of BBP-398 in combination with nivolumab

Phase 1b Dose Expansion: Assess antitumor activity of BBP-398 in combination with nivolumab

Anti-tumor activity will be defined by objective response rate (ORR) according to RECIST v1.1

Secondary Outcome Measures

Assess preliminary antitumor activity of BBP-398 in combination with nivolumab

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

Full Information

NCT ID

NCT05375084

First Posted

May 10, 2022

Last Updated

August 16, 2023

Sponsor

Navire Pharma Inc., a BridgeBio company

Collaborators

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT05375084

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 20, 2022 (Actual)

Primary Completion Date

July 2024 (Anticipated)

Study Completion Date

January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Navire Pharma Inc., a BridgeBio company

Collaborators

Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non Small Cell Lung Cancer, Solid Tumor

Keywords

KRAS mutation, MAPK-pathway alterations, NSCLC, SHP2

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Dose Escalation Level 1

Arm Type

Experimental

Arm Description

Level 1 oral capsules administered in combination with nivolumab

Arm Title

Dose Escalation Level 2

Arm Type

Experimental

Arm Description

Level 2 oral capsules administered in combination with nivolumab

Arm Title

Dose Escalation Level 3

Arm Type

Experimental

Arm Description

Level 3 oral capsules administered in combination with nivolumab

Arm Title

Dose Expansion

Arm Type

Experimental

Arm Description

RP2D defined dose. Oral capsules administered in combination with nivolumab

Intervention Type

Drug

Intervention Name(s)

BBP-398 with nivolumab

Intervention Description

BBP-398 administered orally once a day (QD); nivolumab administered intravenously every 4 weeks (Q4wks)

Primary Outcome Measure Information:

Title

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)

Title

Phase 1b Dose Expansion: Assess antitumor activity of BBP-398 in combination with nivolumab

Description

Anti-tumor activity will be defined by objective response rate (ORR) according to RECIST v1.1

Time Frame

Completion of 1 Cycle (28 days)

Secondary Outcome Measure Information:

Title

Assess preliminary antitumor activity of BBP-398 in combination with nivolumab

Description

Time Frame

Completion of 1 Cycle (28 days)

Title

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)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Navire Clinical Operations

Phone

650-391-9740

NAV1004ct.gov@bridgebio.com

Facility Information:

Facility Name

Highlands Oncology

City

Springdale

State/Province

Arkansas

ZIP/Postal Code

72762

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Allie Clemons

Phone

479-872-8130

research@hogonc.com

First Name & Middle Initial & Last Name & Degree

Eric S Schaefer, MD

Facility Name

Scripps Clinic Torrey Pines

City

La Jolla

State/Province

California

ZIP/Postal Code

92037

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kiley Borchard, CCRC

crs_leadership_research@scrippshealth.org

First Name & Middle Initial & Last Name & Degree

Michael Kosty, MD

Facility Name

Providence Medical Foundation

City

Santa Rosa

State/Province

California

ZIP/Postal Code

95403

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tracy Foster

Phone

707-521-3830

tracy.foster@stjoe.org

First Name & Middle Initial & Last Name & Degree

Ian Anderson, MD

Facility Name

Memorial Regional Hospital (Memorial Cancer Institute)

City

Hollywood

State/Province

Florida

ZIP/Postal Code

33021

Country

United States

Individual Site Status

Recruiting

Facility Name

Moffitt Cancer Center

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Eduardo Galvez

Phone

813-745-4673

Eduardo.Galvez@moffitt.org

First Name & Middle Initial & Last Name & Degree

Bruna Pellini, MD

Facility Name

Cleveland Clinic

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jessica Grebenc

Phone

216-444-7923

canceranswer@ccf.og

First Name & Middle Initial & Last Name & Degree

Nathan Pennell, MD, PhD

Facility Name

Providence Portland Medical Center

City

Portland

State/Province

Oregon

ZIP/Postal Code

97213

Country

United States

Individual Site Status

Recruiting

Facility Contact:

CanRsrchStudies@providence.org

First Name & Middle Initial & Last Name & Degree

Rachel Sanborn, MD

Facility Name

University of Pennsylvania (Abramson Cancer Center)

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Individual Site Status

Recruiting

Facility Name

MD Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Individual Site Status

Recruiting

Facility Name

NEXT Oncology

City

Fairfax

State/Province

Virginia

ZIP/Postal Code

22031

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Blake Patterson

Phone

703-783-4510

bpatterson@nextoncology.com

First Name & Middle Initial & Last Name & Degree

Alex Spira

12. IPD Sharing Statement

Learn more about this trial

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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