Safety, Efficacy and Pharmacokinetic of BPI-9016M in Patients With c-Met- Dysregulated Advanced NSCLC

• Status: Recruiting
• Trial end date: 2024-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The main objective of this study is to evaluate the safety, tolerability, efficacy and pharmacokinetics of BPI-9016M in patients with c-Met-dysregulated advanced NSCLC. Biomarkers related to the efficacy of BPI-9016M will be investigated.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Betta Pharmaceuticals Co., Ltd.; Betta Pharmaceuticals Co.,Ltd.

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed, locally advanced or metastatic NSCLC patients, who is not suitable for surgery or radiotherapy

• Evaluable or measurable disease per Response Evaluation Criteria in Solid Tumors(RECIST1.1)

• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

• Life expectancy ≥12 weeks

• Must have evidence of positive c-Met protein expression by IHC from either local data or the results of molecular pre-screening evaluations；Must haved evidence of MET exon 14 skipping alterations in blood and/or tissue samples.

• Adequate bone marrow, hepatic, and renal function

• Patients of child bearing potential must agree to take contraception during the study and for 3 months after the last day of treatment

• Signed Informed Consent Form

Exclusion Criteria:

• Prior or current treatment with the type II of c-MET inhibitor or HGF/c-Met antibody therapy

• Confirmed ALK or ROS1 rearrangement

• Prior treatment with targeting agents (Including EGFR tyrosine kinase inhibitors,VEGFR TKIs,the tpye I of MET TKIs, etc.) within 14 days or 5 half-life

• Prior treatment with anticancer agents (Including cytotoxic chemotherapy,radiotherapy, immunotherapy etc.) within 4 weeks

• Brain/meninges metastases unless asymptomatic, stable and not requiring steroids for maintenance

• History of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease, radiological documentation of idiopathic pulmonary fibrosis at baseline; uncontrolled pleural effusion/pericardial effusion

• Any evidence of severe or uncontrolled systemic diseases, including CTCAE 2 or higher active infection, unstable angina pectoris, congestive cardiac failure and severe liver/renal or metabolic disease

• Active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV)

• History of organ transplant; had surgery or severe injury within 4 weeks

• Uncontrolled hypertension（Systolic blood pressure≥160mmHg and/or diastolic blood pressure≥100mmHg ）

• Patients unable to swallow orally administered medication, prior surgical procedures affecting absorption.

• Pregnant (positive pregnancy test) or lactating women