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

December 11, 2025 updated by: Shandong Suncadia Medicine Co., Ltd.

A Phase I Clinical Study of the Safety, Tolerability, Pharmacokinetics, and Initial Efficacy of HRS-6208 Monotherapy in Patients With Advanced Solid Tumors

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

206

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • Recruiting
        • Nanjing Drum Tower Hospital
        • Principal Investigator:
          • Hongqian Guo
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • West China Hospital of Sichuan University
        • Principal Investigator:
          • Ping Feng
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ting Luo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental arm
Drug: HRS-6208
HRS-6208.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence and severity of adverse events (AEs)
Time Frame: From Day 1 to 30 days after the last dose.
From Day 1 to 30 days after the last dose.
Maximum tolerated dose (MTD)
Time Frame: From Day 1 to 21 days after the first dose.
From Day 1 to 21 days after the first dose.
Recommended phase 2 dose (RP2D)
Time Frame: From Day 1 to 30 days after the last dose.
From Day 1 to 30 days after the last dose.
Dose limiting toxicity (DLT)
Time Frame: From Day 1 to 21 days after the first dose.
From Day 1 to 21 days after the first dose.

Secondary Outcome Measures

Outcome Measure
Time Frame
Objective Response Rate (ORR)
Time Frame: From time of first dose of HRS-6208 until the date of objective disease progression or death (up to 24 months).
From time of first dose of HRS-6208 until the date of objective disease progression or death (up to 24 months).
Duration of Response (DoR)
Time Frame: From time of first dose of HRS-6208 until the date of objective disease progression or death (up to 24 months).
From time of first dose of HRS-6208 until the date of objective disease progression or death (up to 24 months).
Disease Control Rate (DCR)
Time Frame: From time of first dose of HRS-6208 until the date of objective disease progression or death (up to 24 months).
From time of first dose of HRS-6208 until the date of objective disease progression or death (up to 24 months).
Progression free Survival (PFS)
Time Frame: From time of first dose of HRS-6208 until the date of objective disease progression or death (up to 24 months).
From time of first dose of HRS-6208 until the date of objective disease progression or death (up to 24 months).
Overall Survival (OS)
Time Frame: From time of first dose of HRS-6208 until the date of objective disease progression or death (up to 24 months).
From time of first dose of HRS-6208 until the date of objective disease progression or death (up to 24 months).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong Suncadia Medicine Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 17, 2024

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Study Registration Dates

First Submitted

December 6, 2024

First Submitted That Met QC Criteria

December 6, 2024

First Posted (Actual)

December 11, 2024

Study Record Updates

Last Update Posted (Actual)

December 18, 2025

Last Update Submitted That Met QC Criteria

December 11, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HRS-6208-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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