Skip to main content
OpenTrials
Completed

NCT Number: NCT05463432

A Study of HR19024 in Subjects With Advanced Solid Tumor

To evaluate the safety，tolerability，pharmacokinetic characteristics and preliminary efficacy of HR19024 injection in the treatment of advanced solid tumor

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Advanced Solid Tumor

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ECOG performance status 0 or 1
  • Histologically confirmed advanced solid tumor
  • Life expectancy of greater than or equal to (>=) 12 weeks
  • At least one measurable lesion is present according to the efficacy evaluation criteria for solid tumors (RECIST 1.1)
  • Able and willing to provide a written informed consent

Exclusion criteria

  • Subjects with unresolved toxicity （> CTCAE G1）of prior therapy at the time of enrolment
  • Subjects who had received anti-tumor treatments such as surgery, chemotherapy, radiotherapy recently

Treatment and study plan

HR19024

Drug

Intravenous infusion

Primary outcomes

  1. Maximum tolerated dose (MTD) of HR19024

    Time frame: 21-day cycle (tri-weekly)

Secondary outcomes

  1. Response rate (RR)

    Time frame: up to 6 months following the date the last patient was randomized

  2. Disease Control Rate

    Time frame: up to 6 months following the date the last patient was randomized

  3. Duration of Response

    Time frame: up to 6 months following the date the last patient was randomized

  4. Progression free survival (PFS)

    Time frame: up to 6 months following the date the last patient was randomized

Sponsors and collaborators

Lead sponsor

Shanghai Hengrui Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

An Open-label Phase 1a Study of the Safety and Tolerability of HR19024 Injection in Subjects With Advanced Solid Tumor

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 19, 2022
Registry last updated
Mar 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.