PH009-1 in Patients With EGFR Mutation Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)

Launched by SUZHOU PUHE PHARMACEUTICAL TECHNOLOGY CO., LTD · Sep 5, 2024

Keywords

ClinConnect Summary

This clinical trial, called PH009-1, is studying a new treatment for patients with advanced or metastatic non-small cell lung cancer (NSCLC) that has a specific genetic change called an EGFR mutation. The trial has three stages, starting with small groups of patients to find the right dose of the treatment. Once the dosage is confirmed, researchers can choose to expand the study to include more participants. The trial is not yet recruiting patients, but it aims to help those who have not had successful results from previous treatments.

To be eligible for this trial, participants need to be at least 18 years old and have a confirmed diagnosis of NSCLC that cannot be surgically removed. They also should have at least one measurable tumor and a good performance score indicating they are able to carry out daily activities. Participants will need to meet specific health criteria and will have to sign a consent form before starting any trial-related processes. It's important to note that there are certain treatments or health conditions that might prevent someone from joining the trial, so potential participants should discuss their medical history with their doctor.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥18 years, signed informed consent form before any trial-related processes.
• • 2. Histological or cytological confirmed diagnosis of unresectable locally advanced or metastatic NSCLC.
• • 3. Subjects must have NSCLC harboring one or more active EGFR mutations.
• • 4. patients must have at least one measurable tumor lesion per RECIST v1.1 criteria as per Investigator\'s assessment.
• • 5. The Eastern Cancer Cooperative Group (ECOG) performance score of 0 or 1.
• • 6. Life expectancy ≥12 weeks.
• • 7. Adequate hematologic and organ function per protocol.
• • 8. WOCBP must have a negative serum and/or urine pregnancy test result within 7 days prior to the first dose of PH009-1.
• Exclusion Criteria:
• 1. Treatment with any of the following:
• • Prior treatment with an EGFR-TKI within 8 days prior to the first dose of PH009-1; Prior treatment with immunotherapy or biotherapy within 4 weeks prior to the first dose of PH009-1; Radiotherapy (palliative radiotherapy completed at least 2 weeks prior to the first dose of Ph009-1 can be enrolled) within 4 weeks prior to the first dose of PH009-1; Herbal therapy that has anti-tumor effects within 2 weeks prior to the first dose of PH009-1; Mitomycin and nitrosourea within 6 weeks prior to the first dose of PH009-1; Oral fluorouracil such as tegafur and capecitabine within 2 weeks prior to the first dose of PH009-1; Chemotherapy (except for mitomycin, nitrosourea, and fluorouracil oral drugs), or other anti-tumor drugs for the treatment of NSCLC within 4 weeks prior to the first dose of PH009-1. Marketed and/or experimental drug treatment for EGFR C797S mutations.
• • 2. Is currently participating and receiving investigational therapy or using an investigational device, or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the investigational product, whichever is longer, prior to the first dose of PH009-1.
• • 3. Is expected to require any other form of anti-tumor therapy while on study.
• • 4. Unresolved toxicity greater than CTCAE v5.0 Grade 1 from prior anti-tumor therapy prior to the first dose.
• • 5. Medical history of severe eye disease or skin disease without recovery to CTCAE v5.0 Grade 0 or 1 prior to the first dose.
• • 6. Any of the following cardiovascular diseases within the last 6 months: include but not limited to QTc interval ≥ 470 msec.
• • 7. Medical history of ILD.
• • 8. Subjects with gastrointestinal disorders that may affect oral administration or interfere with the absorption of PH009-1, or severe gastrointestinal disease within 4 weeks prior to the first dose of PH009-1 and did not recover to ≤ CTCAE v5.0 Grade 2.
• • 9. Major surgery or significant traumatic injury occurring within 4 weeks prior to the first dose of PH009-1 or anticipation of need for a major surgery during the study.
• • 10. Has any bleeding tendency or coagulopathy within 6 months prior to the first dose of PH009-1.