NCT06266143

A Trial of Y101D in Combination With Gemcitabine and Albumin Paclitaxel in Patients With Advanced Pancreatic Cancer

Phase Ib/II Trial of Y101D Combined With Gemcitabine and Albumin Paclitaxel in First-line Treatment of Patients With Advanced Pancreatic Cancer

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Wuhan YZY Biopharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The Phase Ib/II 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 20mg/kg or 30mg/kg. 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.

Conditions

• Advanced Pancreatic Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Y101D	Intravenous infusion of Y101D at day1, combined with Gemcitabine and Nab-Paclitaxel IV infusion at day1, 8, a 21-day cycle. After 6 cycles, Y101D and Gemcitabine infusion is applied as the maintenance treatment.

Timeline

• Start date: 2023-02-08
• Primary completion: 2025-03-21
• Completion: 2025-10-20
• First posted: 2024-02-20
• Last updated: 2025-07-20

Locations

1 site across 1 country: China