Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06266143
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-20
First Post:
2024-01-24
Brief Title:
A Trial of Y101D in Combination With Gemcitabine and Albumin Paclitaxel in Patients With Advanced Pancreatic Cancer
Sponsor:
Wuhan YZY Biopharma Co Ltd
Organization:
Wuhan YZY Biopharma Co Ltd
Study Overview
Official Title:
Phase IbII Trial of Y101D Combined With Gemcitabine and Albumin Paclitaxel in First-line Treatment of Patients With Advanced Pancreatic Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-01
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 Phase IbII study is an open-label single-arm multicenter trial designed to assess the efficacy and safety of Y101D in combination with Gemcitabine and Albumin Paclitaxel as first-line systemic treatment for advanced pancreatic cancer patients The Phase Ib portion of the study aims to evaluate the safety of escalating doses of Y101D in combination with the standard regimen of Gemcitabine and Albumin Paclitaxel and determine the recommended phase 2 dose RP2D The Phase II portion of the study aims to evaluate the effectiveness of this combination treatment in a small population of patients
Detailed Description:
A total of 57-81 systemic treatment-naïve patients with advanced pancreatic cancer will be enrolled in the study Phase Ib will enroll 12-36 patients to assess the safety of Y101D combined with Gemcitabine and Albumin Paclitaxel at doses of 20mgkg or 30mgkg The recommended phase 2 dose RP2D for Y101D in combination with the other drugs will be determined based on the safety profile and preliminary efficacy data
Following determination of the RP2D Phase II will enroll a total of 40-45 patients to evaluate the effectiveness of the combination treatment using the RP2D of Y101D The primary endpoint of the Phase II study will be the objective response rate Secondary endpoints will include progression-free survival PFS overall survival OS duration of response DOR and safety profiles Pharmacodynamic parameters such as serum tumor biomarkers and TGF-β concentration will also be evaluated
Overall the study aims to assess the safety efficacy and pharmacodynamics of Y101D in combination with Gemcitabine and Albumin Paclitaxel as a first-line systemic treatment for advanced pancreatic cancer patients
Following determination of the RP2D Phase II will enroll a total of 40-45 patients to evaluate the effectiveness of the combination treatment using the RP2D of Y101D The primary endpoint of the Phase II study will be the objective response rate Secondary endpoints will include progression-free survival PFS overall survival OS duration of response DOR and safety profiles Pharmacodynamic parameters such as serum tumor biomarkers and TGF-β concentration will also be evaluated
Overall the study aims to assess the safety efficacy and pharmacodynamics of Y101D in combination with Gemcitabine and Albumin Paclitaxel as a first-line systemic treatment for advanced pancreatic cancer patients
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