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

NCT04481009 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2022-12-12

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Eucure (Beijing) Biopharma Co., Ltd

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-04
Primary Completion
2022-05-16
Completion
2022-05-26

Countries

  • Australia

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04481009 on ClinicalTrials.gov