NCT05031494

A Study to Assess YH003 in Combination with Toripalimab(anti-PD-1 MAb) Injection in Patients with Cancers

A Multi-center, Open-label Phase II Study to Evaluate the Safety and Efficacy of YH003 in Combination with Toripalimab (anti-PD-1 MAb) in Patients with Unresectable/metastatic Melanoma and Pancreatic Ductal Adenocarcinoma (PDAC)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Eucure (Beijing) Biopharma Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A phase II, multi-center, open-label study to evaluate the safety and efficacy of YH003 in combination with Toripalimab (anti-PD-1 mAb) in patients with unresectable/metastatic melanoma and pancreatic ductal adenocarcinoma (PDAC)

Conditions

• Melanoma
• Pancreatic Ductal Adenocarcinoma

Interventions

Type	Name	Description
DRUG	YH003	YH003 will be dosed at RP2D every 3 weeks. The first infusion of YH003 should be administered over 60 minutes.
DRUG	Toripalimab	Toripalimab will be administered at a dose of 240 mg every 3 weeks.
DRUG	Nab-paclitaxel	Nab-paclitaxel will be administered each 21-day cycle.
DRUG	Gemcitabine	Gemcitabine will be administrated each 21-day cycle.

Timeline

• Start date: 2021-12-08
• Primary completion: 2023-08-16
• Completion: 2023-08-16
• First posted: 2021-09-02
• Last updated: 2025-01-06

Locations

2 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated drug study