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

Non-small Cell Lung Cancer Clinical Trial

Official title:

Safety, Efficacy and Pharmacokinetic of BPI-9016M in Patients With c-Met- Dysregulated Advanced NSCLC: A Phase Ib Study,Open-label,Dose-expansion Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02929290
• Other study ID #: BD-CM-I02
• Status: Recruiting
• Phase: Phase 1
• Start date: March 1, 2017
• Est. completion date: November 2024

Study information

• Verified date: September 2021
• Source: Betta Pharmaceuticals Co., Ltd.
• Contact: Yuankai Shi, MD
• Email: syuankai[@]yahoo.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This study was a multicenter, open, single-arm, Ib-stage expanded clinical study.

Part I：On the basis of Ia-stage dose escalation study, a safe and effective dose of -300 mg, 450 mg, 600 mg and 800 mg was selected to enlarge the enrollment study in patients with c-Met-dysregulated advanced NSCLC, and continuously administered until the disease progressed or could not be tolerated, in order to further evaluate the safety, ttolerability, efficacy and pharmacokinetics of BPI-9016M.

Part II：On the basis of the completed research results of Ia stage and part I, a safe and effective dose of 400 mg twice a day (bid) was selected to conduct an expanded enrollment study in NSCLC patients with MET exon 14 skipping alterations, and continuously administered until the disease progressed or could not be tolerated, in order to further evaluate the safety, ttolerability, efficacy and pharmacokinetics of BPI-9016M.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-small Cell Lung Cancer

Intervention

Drug:
• BPI-9016M
Part I:Four dose cohorts will be evaluated, including 300mg, 450mg, 600mg, 800mg. BPI-9016M Tablet will be administered orally to patients once daily for each dose cohort. Part II:400mg BPI-9016M Tablet will be administered orally to patients twice a day.

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing
China	Department of Medical Oncology, Cancer Institute/Hospital, Chinese Academy of Medical Sciences	Beijing	Beijing
China	Peking Union Medical College Hospital	Beijing	Beijing
China	Affiliated Cancer Hospital of Harbin Medical University	Harbin	Heilongjiang
China	The Second Affiliated Hospital of Anhui Medical University	Hefei	Anhui
China	The First Hospital of China Medical University	Shenyang	Liaoning
China	Fourth Hospital of Hebei Medical University	Shijiazhuang	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
Betta Pharmaceuticals Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participants with Adverse Events		18 months
Primary	Objective Response Rate		16 weeks
Primary	Disease Control Rate		16 weeks
Secondary	AUCss		4 weeks
Secondary	Css-min		18 months
Secondary	Progression-Free Survival		18 months
Secondary	Overall Survival		24 months