Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-01-03 @ 11:57 PM
Study NCT ID:
NCT06590194
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-09-19
First Post:
2024-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PH009-1 in Patients With EGFR Mutation Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)
Sponsor:
Suzhou Puhe Pharmaceutical Technology Co., LTD
Organization:
Study Overview
Official Title:
A Phase I/IIa, Open-label, Dose-escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Preliminary Anti-tumor Activity of PH009-1 in Patients With EGFR Mutation Locally Advanced or Metastatic NSCLC
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study will contain three stages: Phase I includes dose escalation phase (i.e., phase Ia) and dose expansion phase (i.e., phase Ib). Once the dosage regimen is confirmed, the sponsor can decide to start the cohort expansion phase (i.e., phase IIa)
Detailed Description:
phase Ia (Dose Escalation Phase) Approximately 17-96 subjects will be enrolled, dose escalation will be implemented by combining accelerated escalation with "3+3" design and safety evaluation requirements as specified. The total number of the subjects will depend upon the number of dose escalation necessary.
Phase Ib (Dose Expansion Phase): 2 to 3 doses selected from escalation doses, up to 20 subjects (subjects in dose escalation are involved) will be enrolled in each expansion arm, the total number of subjects will depend upon the number of dose expansions, expansions may adjusted depends upon the emerging data.
Phase IIa (Cohort Expansion): Approximately 20 subjects will be enrolled in each expansion cohort. Sample size may be adjusted based on emerging data.
Phase Ib (Dose Expansion Phase): 2 to 3 doses selected from escalation doses, up to 20 subjects (subjects in dose escalation are involved) will be enrolled in each expansion arm, the total number of subjects will depend upon the number of dose expansions, expansions may adjusted depends upon the emerging data.
Phase IIa (Cohort Expansion): Approximately 20 subjects will be enrolled in each expansion cohort. Sample size may be adjusted based on emerging data.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: