NCT05463432

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Aug 2022

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 7, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 19, 2022

Completed
22 days until next milestone

Study Start

First participant enrolled

August 10, 2022

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 22, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 22, 2024

Completed
Last Updated

March 20, 2025

Status Verified

March 1, 2025

Enrollment Period

2.2 years

First QC Date

July 7, 2022

Last Update Submit

March 19, 2025

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (1)

  • Maximum tolerated dose (MTD) of HR19024

    21-day cycle (tri-weekly)

Secondary Outcomes (4)

  • Response rate (RR)

    up to 6 months following the date the last patient was randomized

  • Disease Control Rate

    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

  • Progression free survival (PFS)

    up to 6 months following the date the last patient was randomized

Study Arms (1)

HR19024

EXPERIMENTAL

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

Drug: HR19024

Interventions

HR19024DRUG

Intravenous infusion

HR19024

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: HR19024 for all enrolled subjects
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2022

First Posted

July 19, 2022

Study Start

August 10, 2022

Primary Completion

October 22, 2024

Study Completion

October 22, 2024

Last Updated

March 20, 2025

Record last verified: 2025-03

Locations

CN(1)