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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05480865
Other study ID # NAV-1003
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date July 6, 2022
Est. completion date June 2025

Study information

Verified date January 2024
Source Navire Pharma Inc., a BridgeBio company
Contact Navire Clinical Operations
Phone 650-391-9740
Email NAV1003ct.gov@bridgebio.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a Phase 1 study of BBP-398, a SHP2 inhibitor, in combination with sotorasib, a KRAS-G12C inhibitor (KRAS-G12Ci), in patients with a KRAS-G12C mutation. The study involves 2 parts: Phase 1a Dose Escalation and Phase 1b Dose Expansion/Optimization.


Description:

The primary objectives for Phase 1a Dose Escalation are to evaluate safety and tolerability, and recommend a phase 1b dose (RP1bD) of the combination. The primary objectives for Phase 1b Dose Expansion/Optimization are to evaluate safety and tolerability, and the antitumor activity (defined by the ORR assessed by the investigator according to RECIST v1.1) of BBP-398 when used in combination with sotorasib across two dose regimens in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a KRAS-G12C mutation and who are KRAS-G12Ci naïve, and recommend a phase 2 dose (RP2D) of the combination.


Recruitment information / eligibility

Status Recruiting
Enrollment 85
Est. completion date June 2025
Est. primary completion date June 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Key Inclusion Criteria: - Patients must have histologically documented, locally advanced and unresectable, or metastatic solid tumor with documentation of a KRAS-G12C mutation within 2 years 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 all available standard of care therapies. - 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 untreated and/or active CNS metastases. - Patients that have a history of allogenic bone marrow transplant.

Study Design


Intervention

Drug:
BBP-398
BBP-398 administered orally
sotorasib
sotorasib administered orally

Locations

Country Name City State
Australia Cancer Research SA Adelaide South Australia
Australia Southern Oncology Clinical Research Unit Adelaide South Australia
Australia Peninsula & South Eastern Haematology and Oncology Group Frankston Victoria
Australia Orange Health Service Orange
Australia One Clinical Research Perth Western Australia
Australia St John of God Subiaco Hospital Subiaco Western Australia
Denmark Rigshospitalet Copenhagen
France Institute Bergonie Bordeaux
France Centre Georges François Leclerc Dijon
France CHU Grenobles Aples Grenoble
France Hopital Bichat-Claude Bernard Paris
France CHU de Rennes - Hôpital Pontchaillou Rennes
Greece St. Luke's Hospital S.A. Thessaloníki
Italy Spedali Civili - Brescia Brescia
Italy Careggi University Hospital Florence Largo Brambilla
Italy Istituto Nazionale Tumori (INT) "Fondazione G. Pascale" Napoli
Italy U.O.C Oncoematologia AOU "Luigi Vanvitelli" Napoli
Netherlands Het Nederlands Kanker Instituut - Antoni van Leewenhoek Ziekenhuis Amsterdam
Netherlands Erasmus Medical Center Rotterdam
Spain Quiron Salud Barcelona Barcelona
Spain Vall d'Heborn University Hospital - VHIO Barcelona
Spain Clinica Universidad de Navarra Madrid
Spain Quiron Salud Madrid Madrid
Spain Virgen De La Victoria Málaga
Spain Hospital Universitario Virgen De La Macarena Sevilla

Sponsors (2)

Lead Sponsor Collaborator
Navire Pharma Inc., a BridgeBio company Amgen

Countries where clinical trial is conducted

Australia,  Denmark,  France,  Greece,  Italy,  Netherlands,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Phase 1a Dose Escalation Primary Objective: Incidence and Severity of Treatment-Emergent Adverse Events, Serious Adverse Events, and Dose Limiting Toxicities Number of patients experiencing treatment-emergent adverse events, serious adverse events, including changes in lab parameters, vital signs and electrocardiogram changes; duration, and severity based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Completion of 1 Cycle (28 days)
Primary Phase 1b Dose Expansion/Optimization Primary Objective: Incidence and Severity of Treatment-Emergent Adverse Events, and Serious Adverse Events Number of patients experiencing treatment-emergent adverse events, serious adverse events, including changes in lab parameters, vital signs and electrocardiogram changes; duration, and severity based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Completion of 1 Cycle (28 days)
Primary Phase 1b Dose Expansion/Optimization Primary Objective: Overall Response Rate (ORR) Complete Response (CR) + Partial Response (PR) rates, defined by RECIST v1.1 8 weeks
Secondary Phase 1a Dose Escalation Secondary Objectives: Overall Response Rate (ORR) Complete Response (CR) + Partial Response (PR) rates, defined by RECIST v1.1 8 weeks
Secondary Duration of response Defined by RECIST v1.1 8 weeks
Secondary Progression Free Survival (PFS) Time from treatment start to progression of disease or death by any cause 8 weeks
Secondary Overall survival (OS) Time from treatment start to death 8 weeks
Secondary Maximum Observed Plasma Concentration (Cmax) of BBP-398 Maximum plasma concentration of BBP-398 in combination with sotorasib Cycle 2 Day 1
Secondary Time to Cmax (Tmax) of BBP-398 Amount of time to reach Cmax of BBP-398 in combination with sotorasib Cycle 2 Day 1
Secondary Area under the plasma concentration-time curve (AUC) of BBP-398 Area under the plasma concentration versus time curve of BBP-398 in combination with sotorasib Cycle 2 Day 1
Secondary Half-life (T1/2) of BBP-398 Terminal half-life of BBP-398 in combination with sotorasib Cycle 2 Day 1
Secondary Observed Maximum Plasma Concentration (Cmax) of sotorasib Maximum plasma concentration of sotorasib in combination with BBP-398 Cycle 2 Day 1
Secondary Time to Cmax (Tmax) of sotorasib Amount of time to reach Cmax of sotorasib in combination with BBP-398 Cycle 2 Day 1
Secondary Area under the plasma concentration-time curve (AUC) over dosing interval of sotorasib Area under the plasma concentration versus time curve of sotorasib in combination with BBP-398 Cycle 2 Day 1
Secondary Half-life (T1/2) of sotorasib Terminal half-life of sotorasib in combination with BBP-398 Cycle 2 Day 1
Secondary Circulating and intratumoral target engagement biomarkers of BBP-398 activity in combination with sotorasib Raw, normalized, and/or baseline adjusted analyte signal 24 months
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