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| Name | Class |
|---|---|
| Amgen | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation: BBP-398 Level 1 and sotorasib | Experimental | BBP-398 dose Level 1 capsules administered once a day (QD) for a 28-day treatment cycle in combination with sotorasib tablets administered once a day (QD) for a 28-day treatment cycle |
|
| Dose Escalation: BBP-398 Level 2 and sotorasib | Experimental | BBP-398 dose Level 2 capsules administered once a day (QD) for a 28-day treatment cycle in combination with sotorasib tablets administered once a day (QD) for a 28-day treatment cycle |
|
| Dose Escalation: BBP-398 Level 3 and sotorasib | Experimental | BBP-398 dose Level 3 capsules administered once a day (QD) for a 28-day treatment cycle in combination with sotorasib tablets administered once a day (QD) for a 28-day treatment cycle |
|
| Dose Expansion/Optimization: BBP-398 Dose Regimen 1 and sotorasib | Experimental | BBP-398 Dose Regimen 1 capsules administered once a day (QD) for a 28-day treatment cycle in combination with sotorasib tablets administered once a day (QD) for a 28-day treatment cycle |
|
| Dose Expansion/Optimization: BBP-398 Dose Regimen 2 and sotorasib |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BBP-398 | Drug | BBP-398 administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| 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) |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1a Dose Escalation Secondary Objectives: Overall Response Rate (ORR) | Complete Response (CR) + Partial Response (PR) rates, defined by RECIST v1.1 | 8 weeks |
| Duration of response | Defined by RECIST v1.1 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Research SA | Adelaide | South Australia | 5000 | Australia | ||
| Southern Oncology Clinical Research Unit |
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| Experimental |
BBP-398 Dose Regimen 2 capsules administered once a day (QD) for a 28-day treatment cycle in combination with sotorasib tablets administered once a day (QD) for a 28-day treatment cycle |
|
| sotorasib | Drug | sotorasib administered orally |
|
| 8 weeks |
| Progression Free Survival (PFS) | Time from treatment start to progression of disease or death by any cause | 8 weeks |
| Overall survival (OS) | Time from treatment start to death | 8 weeks |
| Maximum Observed Plasma Concentration (Cmax) of BBP-398 | Maximum plasma concentration of BBP-398 in combination with sotorasib | Cycle 2 Day 1 |
| Time to Cmax (Tmax) of BBP-398 | Amount of time to reach Cmax of BBP-398 in combination with sotorasib | Cycle 2 Day 1 |
| 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 |
| Half-life (T1/2) of BBP-398 | Terminal half-life of BBP-398 in combination with sotorasib | Cycle 2 Day 1 |
| Observed Maximum Plasma Concentration (Cmax) of sotorasib | Maximum plasma concentration of sotorasib in combination with BBP-398 | Cycle 2 Day 1 |
| Time to Cmax (Tmax) of sotorasib | Amount of time to reach Cmax of sotorasib in combination with BBP-398 | Cycle 2 Day 1 |
| 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 |
| Half-life (T1/2) of sotorasib | Terminal half-life of sotorasib in combination with BBP-398 | Cycle 2 Day 1 |
| Circulating and intratumoral target engagement biomarkers of BBP-398 activity in combination with sotorasib | Raw, normalized, and/or baseline adjusted analyte signal | 24 months |
| Adelaide |
| South Australia |
| 5042 |
| Australia |
| Peninsula & South Eastern Haematology and Oncology Group | Frankston | Victoria | 3199 | Australia |
| One Clinical Research | Perth | Western Australia | 6009 | Australia |
| St John of God Subiaco Hospital | Subiaco | Western Australia | 6008 | Australia |
| Orange Health Service | Orange | NSW 2800 | Australia |
| Rigshospitalet | Copenhagen | DK-2100 | Denmark |
| Institute Bergonie | Bordeaux | 33076 | France |
| Centre Georges François Leclerc | Dijon | 21079 | France |
| CHU Grenobles Aples | Grenoble | 38043 CEDEX9 | France |
| Hopital Bichat-Claude Bernard | Paris | 75018 | France |
| CHU de Rennes - Hôpital Pontchaillou | Rennes | 35000 | France |
| St. Luke's Hospital S.A. | Thessaloniki | 55236 | Greece |
| Careggi University Hospital | Florence | Largo Brambilla | 50134 | Italy |
| Spedali Civili - Brescia | Brescia | 25123 | Italy |
| Istituto Nazionale Tumori (INT) "Fondazione G. Pascale" | Naples | 80131 | Italy |
| U.O.C Oncoematologia AOU "Luigi Vanvitelli" | Naples | 80131 | Italy |
| Het Nederlands Kanker Instituut - Antoni van Leewenhoek Ziekenhuis | Amsterdam | 1066 CX | Netherlands |
| Erasmus Medical Center | Rotterdam | 3000 CA | Netherlands |
| Quiron Salud Barcelona | Barcelona | 08023 | Spain |
| Vall d'Heborn University Hospital - VHIO | Barcelona | 08035 | Spain |
| Clinica Universidad de Navarra | Madrid | 28027 | Spain |
| Quiron Salud Madrid | Madrid | 28223 | Spain |
| Virgen De La Victoria | Málaga | 29010 | Spain |
| Hospital Universitario Virgen De La Macarena | Seville | Spain |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000706028 | sotorasib |
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