Non Small Cell Lung Cancer Clinical Trial
— ArgonautOfficial title:
A Phase 1 Study of the SHP2 Inhibitor BBP-398 (Formerly Known as IACS-15509) in Combination With the KRAS-G12C Inhibitor Sotorasib in Patients With Advanced Solid Tumors and a KRAS-G12C Mutation
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 |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Navire Pharma Inc., a BridgeBio company | Amgen |
Australia, Denmark, France, Greece, Italy, Netherlands, Spain,
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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