- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05463432
A Study of HR19024 in Subjects With Advanced Solid Tumor
August 29, 2022 updated by: Shanghai Hengrui Pharmaceutical Co., Ltd.
An Open-label Phase 1a Study of the Safety and Tolerability of HR19024 Injection 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
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
180
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Hao Geng
- Phone Number: +0518-82342973
- Email: Hao.geng.hg1@hengrui.com
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200032
- Recruiting
- Fudan University Shanghai Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: HR19024
Part 1: Dose escalation of HR19024 montherapy for advanced solid tumor Part 2:PK expansion of HR19024 montherapy for advanced solid tumor Part 3: Efficacy expansion of HR19024 montherapy for advanced solid tumor
|
Intravenous infusion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maximum tolerated dose (MTD) of HR19024
Time Frame: 21-day cycle (tri-weekly)
|
21-day cycle (tri-weekly)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Response rate (RR)
Time Frame: up to 6 months following the date the last patient was randomized
|
up to 6 months following the date the last patient was randomized
|
Disease Control Rate
Time Frame: up to 6 months following the date the last patient was randomized
|
up to 6 months following the date the last patient was randomized
|
Duration of Response
Time Frame: up to 6 months following the date the last patient was randomized
|
up to 6 months following the date the last patient was randomized
|
Progression free survival (PFS)
Time Frame: up to 6 months following the date the last patient was randomized
|
up to 6 months following the date the last patient was randomized
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 10, 2022
Primary Completion (Anticipated)
July 30, 2023
Study Completion (Anticipated)
July 30, 2023
Study Registration Dates
First Submitted
July 7, 2022
First Submitted That Met QC Criteria
July 18, 2022
First Posted (Actual)
July 19, 2022
Study Record Updates
Last Update Posted (Actual)
September 1, 2022
Last Update Submitted That Met QC Criteria
August 29, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HR19024-101
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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