NCT04481009

A Study to Evaluate YH003 in Combination With Toripalimab (Anti-PD-1 mAb) in Subjects With Advanced Solid Tumors

A Multicenter, Open-Label, Phase I/II Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of YH003 in Combination With Toripalimab (Anti-PD-1 mAb) in Subjects With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Eucure (Beijing) Biopharma Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase I/II, multi-center, open-label study of YH003 in combination with Toripalimab (anti-PD-1 mAb). The study is comprised of a dose escalation part (Part I) exploring escalating doses of YH003 in combination with fixed dose toripalimab in subjects with advanced solid tumors (Part I), followed by an expansion part (Part II) with three expansion cohorts.

Detailed description

The study is comprised of a dose escalation part (Part I) exploring escalating doses of YH003 in combination with fixed dose toripalimab in subjects with advanced solid tumors (Part I), followed by an expansion part (Part II) with three expansion cohorts. During Part I, dose escalation part of the study, a traditional 3+3 dose algorithm will be utilized to identify MTD(maximum tolerated dose) and/or RP2D (recommended phase 2 dose). This dose escalation part will consist two phases, the run-in phase to explore safety and tolerability of YH003 as single agent and the combination phase to explore safety and tolerability of escalating doses of YH003 in combination with fixed dose Toripalimab. The Phase II expansion part of this clinical trial will include three parallel cohorts(cohort 2A, 2B and 2C) of 20 subjects each treated with a dose around the RP2D of YH003 in combination with Toripalimab to assess the antitumor activity and safety/tolerability. One expansion cohort (2A) is YH003 and toripalimab in subjects with unresectable/metastatic melanoma, the other two expansion cohorts (2B and 2C) are YH003 and toripalimab with or without nab-paclitaxel + gemcitabine in unresectable/ metastatic pancreatic ductal adenocarcinoma. Subjects will be monitored for safety, tolerability and efficacy throughout the study.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	YH003	YH003 will be administered intravenously over 60 minutes every 21-day cycle.
DRUG	Toripalimab	Toripalimab with fixed dose of 240 mg administered intravenously followed by YH003 administered intravenously every 21-day cycle.
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: 2020-08-04
• Primary completion: 2022-05-16
• Completion: 2022-05-26
• First posted: 2020-07-22
• Last updated: 2022-12-12

Locations

1 site across 1 country: Australia