Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06378177
Status:
RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-04-12
Brief Title:
A Study of LVGN6051 Combination Therapy in Patient With Head and Neck Squamous Cell Carcinoma HNSCC
Sponsor:
Lyvgen Biopharma Holdings Limited
Organization:
Lyvgen Biopharma Holdings Limited
Study Overview
Official Title:
A Phase 2 Study of LVGN6051 Combined With Toripalimab and Paclitaxel for RecurrentMetastatic HNSCC Rapidly Progressed From Previous Platinum-containing Curative Treatment or Contraindicated for Platinum-containing Treatment
Status:
RECRUITING
Status Verified Date:
2024-04
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 purpose of this study is to assess the safety and efficacy of LVGN6051 4-1BB agonistic antibody combined with toripalimab anti-PD-1 antibody and paclitaxel anti-tubulin chemotherapy in patients with recurrentmetastatic head and neck squamous cell carcinoma who rapidly progress from previous neoadjuvant curative or adjuvant platinum-containing therapy or who are currently contraindicated for platinum-containing treatment
Detailed Description:
This is a multicenter open-labeled single-arm Phase 2 clinical study to evaluate the safety and efficacy of LVGN6051 in combination with toripalimab and paclitaxel in selected patients with recurrentmetastatic head and neck squamous cell carcinoma under the guidance of Good Clinical PractiseGCP
This study comprises two parts Part 1 Safety run-in Phase is designed to confirm the dose of combination therapy in Part 2 Part 1 includes a 33 dose-escalation design for 2 dose levels ie LVGN6051 1 mgkg or LVGN6051 2 mgkg with standard doses of toripalimab and paclitaxel every 3 weeks for a treatment cycle Part 1 will treat up to 12 DLT-evaluable patients and the Data monitoring committeeDMC based on the safety profile will confirm the recommended dose for combination therapy in Part 2
Part 2 Efficacy Exploration Phase will treat up to 52 patients with evaluable tumor response efficacy using the recommended dose of combination therapy determined in Part 1 The sample size for Part 2 is based on Simons two-stage minimax design which uses the Response Evaluation Criteria in Solid Tumors RECIST 11 objective response rate ORR as the primary efficacy endpoint The first stage will include 28 patients with evaluable tumor response efficacy If 6 or more responses are observed the second stage 2 will consist of an additional 24 patients with evaluable tumor response Part 1 patients with the same dose level as Part 2 if they meet evaluable tumor response can be included in the required 52 patients with evaluable tumor response
This study comprises two parts Part 1 Safety run-in Phase is designed to confirm the dose of combination therapy in Part 2 Part 1 includes a 33 dose-escalation design for 2 dose levels ie LVGN6051 1 mgkg or LVGN6051 2 mgkg with standard doses of toripalimab and paclitaxel every 3 weeks for a treatment cycle Part 1 will treat up to 12 DLT-evaluable patients and the Data monitoring committeeDMC based on the safety profile will confirm the recommended dose for combination therapy in Part 2
Part 2 Efficacy Exploration Phase will treat up to 52 patients with evaluable tumor response efficacy using the recommended dose of combination therapy determined in Part 1 The sample size for Part 2 is based on Simons two-stage minimax design which uses the Response Evaluation Criteria in Solid Tumors RECIST 11 objective response rate ORR as the primary efficacy endpoint The first stage will include 28 patients with evaluable tumor response efficacy If 6 or more responses are observed the second stage 2 will consist of an additional 24 patients with evaluable tumor response Part 1 patients with the same dose level as Part 2 if they meet evaluable tumor response can be included in the required 52 patients with evaluable tumor response
Study Oversight
Has Oversight DMC:
None
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?:
None