A Study of HR19024 in Subjects With Advanced Solid Tumor

Phase 1

Completed

• Conditions: Advanced Solid Tumor
• Interventions: Drug: HR19024

• Registration Number: NCT05463432
• Lead Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-07
• Study First Submitted QC: 2022-07-18
• Study First Posted: 2022-07-19
• Study Start: 2022-08-10
• Primary Completion: 2024-10-22
• Study Completion: 2024-10-22
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-19
• Last Update Posted: 2025-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HR19024	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

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose (MTD) of HR19024	21-day cycle (tri-weekly)

Secondary Outcome Measures

Name	Time	Method
Disease Control Rate	up to 6 months following the date the last patient was randomized
Progression free survival (PFS)	up to 6 months following the date the last patient was randomized
Response rate (RR)	up to 6 months following the date the last patient was randomized
Duration of Response	up to 6 months following the date the last patient was randomized

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China