Overview

First-in-human Phase I Study of a Selective c-Met Inhibitor PLB1001

Status:
Completed
Trial end date:
2019-10-01
Target enrollment:
0
Participant gender:
All
Summary
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 PLB1001.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Beijing Pearl Biotechnology Limited Liability Company
Criteria
Inclusion Criteria:

- Signed Informed Consent Form

- Age≥18 years

- Histologically or cytologically confirmed advanced non-small cell lung cancer

- Must have evidence of c-Met 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:

- Previous or current treatment with a c-Met inhibitor or HGF-targeting therapy

- 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 > II) Uncontrolled hypertension defined by a Systolic Blood Pressure
(SBP) ≥ 140 mm Hg and/or Diastolic Blood Pressure (DBP) ≥ 90 mm Hg Arrhythmias

- Active peptic ulcer disease or gastritis

- Adverse events from prior anti-cancer therapy that have not resolved to Grade ≤ 1,
except for alopecia

- Major surgery within 4 weeks prior to starting PLB1001

- Previous anti-cancer and investigational agents within 4 weeks before first dose of
PLB1001. If previous treatment is a monoclonal antibody, then the treatment must be
discontinued at least 6 weeks before first dose of PLB1001.

- Pregnant or nursing women

- Involved in other clinical trials < 30 days prior to Day 1