A Study of HR19024 in Subjects With Advanced Solid Tumor

NCT ID: NCT05463432

Last Updated: 2025-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-10

Study Completion Date

2024-10-22

Brief Summary

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

Detailed Description

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Conditions

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Advanced Solid Tumor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

HR19024 for all enrolled subjects
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

HR19024

Intervention Type DRUG

Intravenous infusion

Interventions

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HR19024

Intravenous infusion

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Hengrui Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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HR19024-101

Identifier Type: -

Identifier Source: org_study_id

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