Status:
UNKNOWN
Phase 1 Study of BPI-442096 in Advanced Solid Tumor Patients
Lead Sponsor:
Betta Pharmaceuticals Co., Ltd.
Conditions:
Solid Tumor
Non-small Cell Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
A first-in-human study to evaluate the safety, tolerability and maximum tolerated dose (MTD) and establish the recommended phase 2 dose (RP2D) of BPI-442096, a SHP2 inhibitor, in patients with advance...
Detailed Description
The first-in-human (FIH) study of BPI-442096 will be an open-label, non-randomized, Phase 1 study utilizing a modified "3+3" dose escalation followed by an expansion phase in patients with KRAS G12 mu...
Eligibility Criteria
Inclusion
- Signed informed consent;
- Age ≥18 and ≤75 years, male and female patients;
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1;
- Dose escalation phase: histologically or cytologically confirmed locally advanced or metastatic solid tumor patients (excluding HCC patients), who had disease progression after standard therapy, intolerable to standard therapy, refuse to standard therapy or for whom no standard therapy exists;
- Dose expansion phase: histologically or cytologically confirmed locally advanced non-small cell lung cancer, pancreatic cancer, colorectal cancer or other diagnosed solid tumor patients (excluding HCC patients), who had disease progression after standard therapy, intolerable to standard therapy, refuse to standard therapy or for whom no standard therapy exists;
- Evaluable lesion required for dose escalation phase and at least 1 measurable lesion as per RECIST v1.1 required for dose expansion phase;
- Dose expansion only: Patients must have confirmation of tumour mutation status (including KRAS G12, Class-3 BRAF, NF1 LOF mutations, RTK mutations, amplifications or rearrangements).
- Adequate organ function;
Exclusion
- Patients who have previously received a SHP2 inhibitor;
- Inadequate wash-out of prior therapies described per protocol, which may include anti-tumor therapies, tumor adjuvant drugs, organ or stem cell transplantation, moderate or strong CYP3A inhibitor or inducer;
- Patients with severe or unstable systemic disease, unstable/symptomatic CNS metastasis, other malignant tumors, autoimmune disease, ILD, cardiac disease, bleeding or embolic disease, infectious disease, conditions affecting drug swallow and absorption, medical history leading to chronic diarrhea, etc;
- Pregnancy or lactation;
- Other conditions considered not appropriate to participate in this trial by the investigators.
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2025
Estimated Enrollment :
230 Patients enrolled
Trial Details
Trial ID
NCT05369312
Start Date
June 1 2022
End Date
May 1 2025
Last Update
June 21 2022
Active Locations (5)
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1
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China, 510080
2
The First Affiliated Hospital of Sun yat-sen university
Guangzhou, Guangdong, China, 510080
3
Henan Tumor Hospital
Zhengzhou, Henan, China, 453100
4
Zhongshan Hospital affiliated to Fudan University
Xuhui, Shanghai Municipality, China, 200032