Multicenter Phase I Study of HRS-6208 in Patients With Solid Tumors

NCT ID: NCT06727812

Last Updated: 2025-12-18

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

Total Enrollment

206 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-17

Study Completion Date

2027-08-31

Brief Summary

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This is an open, multicenter Phase I study to evaluate the safety and tolerability of HRS-6208 in patients with advanced solid tumors.

Detailed Description

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Conditions

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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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Experimental arm

Group Type EXPERIMENTAL

HRS-6208

Intervention Type DRUG

HRS-6208.

Interventions

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HRS-6208

HRS-6208.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Patients with unresectable locally advanced or metastatic solid tumors confirmed by histology or cytology who have relapsed or progressed after standard treatment, or have no standard treatment options, or do not apply standard treatment at this stage;
2. Age 18\~75 years old;
3. At least one measurable lesion per RECIST v1.1 criteria;
4. ECOG PS score: 0-1.

Exclusion Criteria

1. History of other malignancies within the past 5 years, excluding cured basal cell carcinoma of the skin and carcinoma in situ of the cervix;
2. The adverse reactions of previous anti-tumor therapy have not recovered to NCI-CTCAE v5.0 grade evaluation ≤ 1;
3. He has severe cardiovascular and cerebrovascular diseases;
4. Severe infection within 4 weeks prior to the first dose.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shandong Suncadia Medicine Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

Site Status RECRUITING

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xin Xu

Role: CONTACT

Phone: 0518-82342973

Email: [email protected]

Zhiye Chen

Role: CONTACT

Phone: 0518-82342973

Email: [email protected]

Facility Contacts

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Hongqian Guo

Role: primary

Ping Feng

Role: primary

Ting Luo

Role: backup

Other Identifiers

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HRS-6208-101

Identifier Type: -

Identifier Source: org_study_id