Recruiting soon

HRS-4508 and Anti-tumor Therapy for Solid Tumor

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What is being tested

HRS-4508+ Capecitabine

+ HRS-4508+ Trastuzumab

+ HRS-4508+ Trastuzumab+ Pertuzumab

Drug
Who is being recruted

From 18 to 75 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1 & 2
Interventional
Study Start: October 2025
See protocol details

Summary

Principal SponsorJiangsu HengRui Medicine Co., Ltd.
Study ContactJiaman LinMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2025

Actual date on which the first participant was enrolled.

This clinical trial is exploring a new treatment option for people with solid tumors, which are abnormal masses of tissue that can occur in various organs. The study aims to determine how effective and safe a combination of different anti-cancer therapies, including a new drug called HRS-4508, is for these patients. This research is crucial because finding a more effective treatment could significantly improve outcomes for individuals with these types of cancers, which are often challenging to treat with existing options. Participants in the study will receive HRS-4508 along with other cancer treatments, and their response to the treatment will be closely monitored. Researchers will measure how well the tumors respond using specific criteria and will also keep track of any side effects experienced. By understanding the best dosage and potential adverse reactions, the study aims to establish a safe and effective treatment regimen. The study also examines how the body absorbs, distributes, and processes HRS-4508 and other drugs used in the combination, providing comprehensive data on their behavior within the body.

Official TitleAn Open, Multicenter Phase IB/II Clinical Study of HRS-4508 in Combination With Other Anti-tumor Therapy for Solid Tumor
NCT07140393
Principal SponsorJiangsu HengRui Medicine Co., Ltd.
Study ContactJiaman LinMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

120 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

6 inclusion criteria required to participate
Age: 18 to 75 years old; Both men and women are welcome;

The mixed cell types need to be confirmed by histology or cytology, and the dominant cell morphology, unresectable or metastatic .

ECOG ratings of 0 or 1.

Expected survival period ≥ 12 weeks.

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5 exclusion criteria prevent from participating
Accompanied by untreated or active central nervous system (CNS) tumor metastasis. Subjects with a history of meningeal metastasis or current meningeal metastasis

There have been significant severe infections and major surgeries in the past 4 weeks

Existence of previous or concurrent malignant tumors

Difficult to treat nausea, vomiting, or other gastrointestinal diseases that affect the use of oral medication

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

6 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Group II

Experimental

Group III

Experimental

Group IV

Experimental

Group 5

Experimental

Group 6

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Cancer Hospital Chinese Academy of Medical Science

Beijing, ChinaOpen Cancer Hospital Chinese Academy of Medical Science in Google Maps
Recruiting soonOne Study Center