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SHP2 Inhibitor BBP-398 in Combination With Sotorasib in Patients With Advanced Solid Tumors and a KRAS-G12C Mutation
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.
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2022-07-06
Primary completion: 2024-06-01
Study completion finish: 2025-06-01
Study type
TREATMENT
Phase
PHASE1
Trial ID
NCT05480865
Intervention or treatment
DRUG: BBP-398
DRUG: sotorasib
Conditions
- • Solid Tumor, Adult
- • Metastatic Solid Tumor
- • Non Small Cell Lung Cancer
- • Metastatic NSCLC
Find a site
Closest Location:
Cancer Research SA
Research sites nearby
Select from list below to view details:
Cancer Research SA
Adelaide, South Australia, Australia
St John of God Subiaco Hospital
Subiaco, Western Australia, Australia
Southern Oncology Clinical Research Unit
Adelaide, South Australia, Australia
Peninsula & South Eastern Haematology and Oncology Group
Frankston, Victoria, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: Dose Escalation: BBP-398 Level 1 and sotorasib
| DRUG: BBP-398
|
EXPERIMENTAL: Dose Escalation: BBP-398 Level 2 and sotorasib
| DRUG: BBP-398
|
EXPERIMENTAL: Dose Escalation: BBP-398 Level 3 and sotorasib
| DRUG: BBP-398
|
EXPERIMENTAL: Dose Expansion/Optimization: BBP-398 Dose Regimen 1 and sotorasib
| DRUG: BBP-398
|
EXPERIMENTAL: Dose Expansion/Optimization: BBP-398 Dose Regimen 2 and sotorasib
| DRUG: BBP-398
|
What is the study measuring?
Primary outcome
| Primary Outcome Measure | Primary Outcome Description | Primary Outcome 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 |
Secondary outcome
| Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome 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 | 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 |
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