A Trial of HRS-6768 in Patients With Advanced Solid Tumors

NCT ID: NCT06925581

Last Updated: 2025-12-03

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

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-24

Study Completion Date

2027-04-30

Brief Summary

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The study is being conducted to evaluate the pharmacokinetics, radiation dosimetry, safety and preliminary efficacy of HRS-6768. To explore the reasonable dosage of HRS-6768 in the treatment of patients with advanced solid tumors.

Detailed Description

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Conditions

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Advanced Solid Tumors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HRS-6768

Group Type EXPERIMENTAL

HRS-6768

Intervention Type DRUG

HRS-6768

Interventions

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HRS-6768

HRS-6768

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Able and willing to provide a written informed consent
2. subjects with solid tumors who have been histologically or cytologically diagnosed with advanced - stage (unresectable or metastatic) disease, have failed standard treatment (disease progression or intolerance), or lack effective treatment methods.
3. There must be at least one evaluable lesion .
4. ECOG 0-1
5. The functions of major organs are in good condition.

Exclusion Criteria

1. The patient has experienced significant weight loss within 28 days prior to signing the informed consent form.
2. The patient has previously received radiopharmaceutical therapy or radioactive embolization, or has previously undergone any external beam radiotherapy (EBRT) involving more than 25% of the bone marrow, or has previously had EBRT directly applied to the kidneys, or has received any EBRT within 2 weeks before the first dose.
3. The patient has received anti - tumor treatments such as surgery (excluding diagnostic biopsy and serous cavity effusion drainage), checkpoint inhibitor therapy, other antibody therapies, chemotherapy, targeted therapy, gene therapy, and vaccine therapy within 4 weeks before the first dose.
4. The patient has had a severe infection (CTCAE \> Grade 2) within 4 weeks before the first dose, such as severe pneumonia requiring hospitalization, bacteremia, and infectious complications. The patient has had symptoms and signs of infection within 2 weeks before the first dose that require intravenous antibiotic treatment (excluding cases of prophylactic antibiotic use).
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Beijing Gaobo Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zengquan Gu

Role: CONTACT

0518-82342973

Other Identifiers

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HRS-6768-101

Identifier Type: -

Identifier Source: org_study_id

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