Status:
UNKNOWN
Assessing the Safety and Efficacy of PLB1004 in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
Lead Sponsor:
Avistone Biotechnology Co., Ltd.
Conditions:
Non-Small-Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a phase I, open-label, multicenter study to assess the safety, tolerability, pharmacokinetics and preliminary antitumor activity of PLB1004, and to determine the maximum tolerated dose (MTD), ...
Detailed Description
The study includes a Dose-escalation Part and a Dose Expansion Part. The aim of the Dose-escalation Part is to estimate the MTD (if possible), identify the DLT (if possible) and the RP2D for PLB1004. ...
Eligibility Criteria
Inclusion
- Ability to understand and the willingness to sign a written informed consent document；
- Aged at least 18 years old;
- Histologically or cytologically confirmed advanced non-small cell lung cancer;
- Patients with EGFR or HER2 mutations;
- ECOG Performance Status of 0-2;
- Life expectancy is not less than 12 weeks;
- At least one measurable lesion as defined by RECIST1.1;
Exclusion
- For the Dose Expansion Part: Patients who have received prior treatment with Poziotinib or TAK788 or other EGFR/HER2 exon20 insertion inhibitors should be excluded；
- Any cytotoxic drugs or other anticancer drugs from a previous treatment regimen within 14 days prior to the first dose of PLB1004；
- Major surgery (e.g., intra-thoracic, intra-abdominal or intra-pelvic) within 4 weeks prior (2 weeks for resection of brain metastases) to starting PLB1004 or who have not recovered from side effects of such procedure;
- Thoracic radiotherapy to lung fields ≤ 4 weeks prior to starting PLB1004. For all other anatomic sites (including radiotherapy to thoracic vertebrae and ribs), radiotherapy ≤ 2 weeks prior to starting PLB1004 or patients who have not recovered from radiotherapy-related toxicities. Palliative radiotherapy for bone lesions ≤ 2 weeks prior to starting PLB1004 is allowed;
- Patients receiving treatment with medications that meet one of the following criteria and that cannot be discontinued at least 1 week prior to the start of treatment with PLB1004 and for the duration of the study:
- Strong inhibitors of CYP3A4
- Strong inducers of CYP3A4
- Inducers or inhibitors of P-gp
- Patients with symptomatic central nervous system (CNS) metastases who are neurologically unstable or have required increasing doses of steroids within the 2 weeks prior to study entry to manage CNS symptoms;
- Clinically significant, uncontrolled heart diseases;
- Presence or history of a malignant disease other than NSCLC that has been diagnosed and/or required therapy within the past 3 years. Exceptions to this exclusion include the following: completely resected basal cell and squamous cell skin cancers, indolent malignancies that currently do not require treatment, and completely resectedcarcinoma in situ of any type;
- Past medical 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;
- History of hypersensitivity to active or inactive excipients of PLB1004 or drugs with a similar chemical structure or class to PLB1004;
- Pregnant or nursing women;
- Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements;
Key Trial Info
Start Date :
August 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2024
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT05347628
Start Date
August 25 2020
End Date
November 30 2024
Last Update
August 21 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Guangdong General Hospital
Guangzhou, Guangdong, China, 510080