Phase I Study of a Selective ALK Inhibitor PLB1003 in Patients With ALK+ NSCLC.

Beijing Pearl Biotechnology

Status and phase

Unknown

Phase 1

Conditions

Non-Small Cell Lung Cancer

Treatments

Drug: PLB1003

Study type

Interventional

Funder types

Industry

Identifiers

NCT03130881

HMO-PLB1003-20160828

Details and patient eligibility

About

This phase I, first-in-human dose-escalation study was conducted to determine the maximum tolerated dose (MTD), recommended phase II dose (RP2D), dose-limiting toxicities (DLTs), pharmacokinetics (PK) profile, and preliminary antitumor activity of PLB1003.

Full description

This is a Phase I, open-label study of PB1003 administered orally to patients with ALK-positive (ALK+) advanced NSCLC. The study includes a Dose-escalation Part (part A) and a Dose Expansion Part (part B). The aim of the part A is to estimate the MTD and to identify the dose limited toxicity(DLT) and the recommended phase II dose (RP2D) for PLB1003 single agent as well as to determine the PK/PD profile. Once response has been observed in certain dose level, then followed by the expansion part to further assess the clinical efficacy and safety of PLB1003 single agent. Aprox 40 patients will be enrolled in PART A, while 12-24 patients for expansion cohort .

PLB1003 is a potent selective ALK inhibitor. PLB1003 acts on cancer by blocking abnormal ALK-mediated signaling, leading to profound tumour growth inhibition in xenografts of non-small cell lung cancer (NSCLC) tumours.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Signed Informed Consent Form
Age≥18 years
Diagnosed with a locally advanced or metastatic non-small cell lung cancer that has progressed despite standard therapy.
Must have evidence of ALK positivity from the results of molecular pre-screening evaluations
At least one measurable lesion as per RECIST v1.1
Patients must have recovered from all toxicities related to prior anticancer therapies to grade ≤ 1
ECOG Performance Status of 0-2

Exclusion criteria

Symptomatic central nervous system (CNS) metastases that are neurologically unstable or requiring increasing doses of steroids to control, and patients with any CNS deficits.
Clinically significant, uncontrolled heart diseases. Unstable angina. History of documented congestive heart failure (New York Heart Association functional classification III-IV) .
Active peptic ulcer disease or gastritis
Major surgery within 4 weeks prior to starting PLB1003
Previous anti-cancer and investigational agents within 4 weeks before first dose of PLB1003..
Pregnant or nursing women
Involved in other clinical trials < 30 days prior to Day 1