A Study of HR19024 in Subjects With Advanced Solid Tumor

Advanced Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05463432
• Other study ID #: HR19024-101
• Status: Recruiting
• Phase: Phase 1
• Start date: August 10, 2022
• Est. completion date: July 30, 2023

Study information

• Verified date: June 2022
• Source: Shanghai Hengrui Pharmaceutical Co., Ltd.
• Contact: Hao Geng
• Phone: +0518-82342973
• Email: Hao.geng.hg1[@]hengrui.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: July 30, 2023
• Est. primary completion date: July 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. ECOG performance status 0 or 1

2. Histologically confirmed advanced solid tumor

3. Life expectancy of greater than or equal to (>=) 12 weeks

4. At least one measurable lesion is present according to the efficacy evaluation criteria for solid tumors (RECIST 1.1)

5. Able and willing to provide a written informed consent

Exclusion Criteria:

1. Subjects with unresolved toxicity (> CTCAE G1)of prior therapy at the time of enrolment

2. Subjects who had received anti-tumor treatments such as surgery, chemotherapy, radiotherapy recently

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Neoplasms

Intervention

Drug:
• HR19024
Intravenous infusion

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Hengrui Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose (MTD) of HR19024		21-day cycle (tri-weekly)
Secondary	Response rate (RR)		up to 6 months following the date the last patient was randomized
Secondary	Disease Control Rate		up to 6 months following the date the last patient was randomized
Secondary	Duration of Response		up to 6 months following the date the last patient was randomized
Secondary	Progression free survival (PFS)		up to 6 months following the date the last patient was randomized