Safety and Pharmacokinetics of BPI-9016M in Patients With Advanced Solid Tumors

NCT02478866 | Completed Phase 1 DMC

• 1 other identifier: BD-CM-I01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

BPI-9016M is a novel, highly potent and selective small-molecule inhibitor of c-Met/Axl kinase. In preclinical studies, it demonstrated strong activity in vitro and in vivo against c-Met/Axl kinase and its downstream signaling targets, and inhibited tumor cell growth. This first-in-human study is conducted to assess the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT), to evaluate the pharmacokinetics, safety and preliminary anti-tumor activity of BPI-9016M with single doses and multiple doses.

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (1)

• Participants with Adverse Events

  The safety and tolerability variables include adverse events, physical examinations, vital signs (specifically including blood pressure), clinical laboratory evaluations including serum chemistry, hematology(Maximum Tolerated Dose) , and urinalysis (with detailed sediment analysis, proteinuria, and 24-hour urine for collection for protein), and electrocardiograms (ECGs) in triplicate,Incidence and nature of DLTs(Dose-Limiting Toxicity),To determine the MTD (Maximum Tolerated Dose).

  24 months

Secondary Outcomes (3)

• Cmax

  1 month

• Half-life time

  1 month

• Tmax

  1 month

Other Outcomes (1)

• Progression-free survival

  18-24 months

Study Arms (1)

BPI-9016M

EXPERIMENTAL

Seven dose cohorts will be evaluated, including 100mg, 200mg, 300mg, 450mg, 600mg, 800mg, 1000mg. BPI-9016M will be administered orally to patients once daily for each dose cohort.

Drug: BPI-9016M

Interventions

BPI-9016M DRUG

Seven dose cohorts will be evaluated, including 100mg, 200mg, 300mg, 450mg，600mg, 800mg, 1000mg. BPI-9016M will be administered orally to patients once daily for each dose cohort.

Also known as: No other name currently

BPI-9016M

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed, locally advanced, or metastatic solid tumor that progressed, or failed to respond to, at least one prior systemic therapy
• Evaluable or measurable disease per Response Evaluation Criteria in Solid Tumors(RECIST1.1)
• Life expectancy ≥3 months
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
• Adequate bone marrow, hepatic, and renal function
• Patients of child bearing potential must agree to take contraception during the study and for 90 days after the last day of treatment
• Signed Informed Consent Form

You may not qualify if:

• Prior treatment with agents of HGF/c-Met inhibitors or HGF/c-Met antibody(Including Crizotinib,Cabozantinib,Volitinib etc.)
• Any anti-cancer therapy, including chemotherapy, hormonal therapy, biologic therapy or radiotherapy within 4 weeks prior to initiation of study treatment
• History of organ transplant; had surgery or severe injury within 4 weeks
• Adverse events from prior anti-cancer therapy that have not resolved to Grade ≤ 2, except for alopecia
• Any evidence of severe or uncontrolled systemic diseases, including CTCAE 3 or higher active infection, unstable angina pectoris, congestive cardiac failure and severe liver/renal or metabolic disease
• Pregnant (positive pregnancy test) or lactating women
• Inability to take oral medication, prior surgical procedures affecting absorption, or active peptic ulcer disease
• Brain/meninges metastases unless asymptomatic, stable and not requiring steroids for maintenance
• Active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV)
• Inability to comply with study and follow-up procedures
• Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the investigator's opinion, gives reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the patient at high risk from treatment complications

Sponsors & Collaborators

• Betta Pharmaceuticals Co., Ltd.: lead

Study Sites (2)

Department of Medical Oncology, Cancer Institute/Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location

Peking Union College Hospital

Beijing, Beijing Municipality, 100032, China

Location

Related Publications (1)

• Hu X, Zheng X, Yang S, Wang L, Hao X, Cui X, Ding L, Mao L, Hu P, Shi Y. First-in-human phase I study of BPI-9016M, a dual MET/Axl inhibitor, in patients with non-small cell lung cancer. J Hematol Oncol. 2020 Jan 16;13(1):6. doi: 10.1186/s13045-019-0834-2.

  PMID: 31948451 DERIVED

Study Officials

• Yuankai Shi, MD

  Department of Medical Oncology, Cancer Institute/Hospital, Chinese Academy of Medical Sciences

  STUDY CHAIR

• Pei Hu, MD

  Peking Union Medical College Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2015
• First Posted: June 23, 2015
• Study Start: August 11, 2015
• Primary Completion: June 30, 2017
• Study Completion: November 1, 2017
• Last Updated: September 16, 2021

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)