Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06590194
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-28
Brief Title:
PH009-1 in Patients With EGFR Mutation Locally Advanced or Metastatic Non-small Cell Lung Cancer NSCLC
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase IIIa 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:
No
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 ie phase Ia and dose expansion phase ie phase Ib Once the dosage regimen is confirmed the sponsor can decide to start the cohort expansion phase ie 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 33 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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None