A Study of PLB1001 in Non-small Cell Lung Cancer With c-Met Dysregulation

  • STATUS
    Recruiting
  • days left to enroll
    9
  • participants needed
    185
  • sponsor
    Beijing Pearl Biotechnology Limited Liability Company
Updated on 19 February 2024
measurable disease
stage iv non-small cell lung cancer
small cell lung cancer

Summary

This is a Phase II, open-label, multicenter and multi-cohorts study of PLB1001 administered orally twice daily to locally advanced/metastatic NSCLC patients with c-Met dysregulation.

Description

PLB1001 will be administrated 200mg twice daily. The treatment will be discontinued for the patients who experience disease progression, death, adverse event (AE) leading to discontinuation or withdrawal of consent. A cycle of study treatment will be defined as 28 days of continuous dosing. The study includes 4 cohorts.

Details
Condition Non-Small Cell Lung Cancer, Non-Small Cell Lung Cancer
Age 18years - 100years
Treatment PLB1001
Clinical Study IdentifierNCT04258033
SponsorBeijing Pearl Biotechnology Limited Liability Company
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

Inclusion Criteria

Signed Informed Consent Form
Age18 years
Histologically or cytologically confirmed advanced non-small cell lung cancer
Must have evidence of c-Met dysregulation 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 0-1

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 > II) Uncontrolled hypertension defined by a Systolic Blood Pressure (SBP) 160 mm Hg and/or Diastolic Blood Pressure (DBP) 100 mm Hg Arrhythmias
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 2 weeks before first dose of PLB1001. If previous treatment is a monoclonal antibody, then the treatment must be discontinued at least 4 weeks before first dose of PLB1001
Pregnant or nursing women
Involved in other clinical trials < 2 weeks prior to Day. If previous treatment of clinical trial is a monoclonal antibody, then the treatment must be discontinued at least 4 weeks before first dose of PLB1001
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

Study AnnotationsStudy Notes

Notes added here are public and can be viewed by anyone. Notes added here are only available to you and those who you share with.

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.