A Phase II Clinical Study of HRS-7058 in Combination With Antitumor Drugs in Patients With Advanced Malignant Tumour

January 22, 2026 updated by: Shandong Suncadia Medicine Co., Ltd.

An Phase II Clinical Study on the Safety, Tolerability and Efficacy of HRS-7058 in Combination With Antitumor Drugs in Subjects With Solid Tumors

This study is a multicentre, open phase II clinical study of dose escalation, dose extension and efficacy extension of HRS-7058 in combination with antitumor drugs in subjects with advanced malignant tumour. To evaluate the safety, tolerability and efficacy of HRS-7058 in combination with antitumor drugs.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Phase 2

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
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100021
        • Recruiting
        • Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
        • Principal Investigator:
          • Yan Wang
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300060
        • Recruiting
        • Tianjin Cancer Hospital
        • Principal Investigator:
          • Dingzhi Huang

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. The subjects gave informed consent to the study before participating in, and voluntarily signed informed consent;
  2. 18 to 75 years old (including both ends), gender is not limited;
  3. Subjects with unresectable locally advanced or metastatic solid tumour confirmed by histopathology;
  4. Having at least one evaluable or measurable lesion according to the solid tumour response Evaluation Criteria (RECIST 1.1);
  5. ECOG Performance Status of 0 or 1;
  6. The expected survival time is more than 12 weeks;
  7. Be able to ingest drugs and be able to comply with trial and follow-up procedures;
  8. Adequate bone marrow and organ function;
  9. Female subjects of childbearing potential must undergo a serum pregnancy test within 7 days before the first administration of the study drug, and the result must be negative; and they must not be lactating. Female subjects of childbearing potential and male subjects whose partners are females of childbearing potential must agree to comply with contraceptive requirements from the time of signing the informed consent form until 5 months after the last administration of the study drug (for male subjects) or 8 months after the last administration of the study drug (for female subjects).

Exclusion Criteria:

  1. Accompanied by untreated or active central nervous system (CNS) tumour metastasis;
  2. Antitumor therapy within 28 days prior to initial use of the investigational drug;
  3. The adverse reactions of previous anti-tumour therapy have not recovered to CTCAE ≤ grade 1;
  4. With known or suspected interstitial pneumonia;
  5. With severe cardiovascular and cerebrovascular disease
  6. Had other malignancies within five years prior to first use of the investigational drug;
  7. Severe infection within 28 days prior to first use of the investigational drug;
  8. History of immune deficiency;
  9. Refractory nausea, vomiting, or other gastrointestinal disorders that affect the use of oral medications;
  10. The presence of uncontrolled pleural, abdominal or pericardial effusion;
  11. Had undergone major organ surgery within 28 days prior to the first use of the study drug;
  12. Women during pregnancy or lactation;
  13. Known allergies and contraindications to the investigational drug or any of its components;
  14. According to the judgment of the investigator, there are any other circumstances that may increase the risks of participating in the study, interfere with the study results, or make the subjects unsuitable for participating in this study.

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HRS-7058 + SHR-1316
Drug: HRS-7058 + SHR-1316
HRS-7058 + SHR-1316
Experimental: HRS-7058 + SHR-1316 + Platinum-containing doublet chemotherapy
Drug: HRS-7058 + SHR-1316 + Platinum-containing doublet chemotherapy
HRS-7058 + SHR-1316 + Platinum-containing doublet chemotherapy
Experimental: HRS-7058 + Cetuximab
Drug: HRS-7058 + Cetuximab
HRS-7058 + Cetuximab
Experimental: HRS-7058 + SHR-1826
Drug: HRS-7058 + SHR-1826
HRS-7058 + SHR-1826
Experimental: HRS-7058 + SHR-1826 + SHR-1316
Drug: HRS-7058 + SHR-1826 + SHR-1316
HRS-7058 + SHR-1826 + SHR-1316
Experimental: HRS-7058 + SHR-A1202
Drug: HRS-7058 + SHR-A1202
HRS-7058 + SHR-A1202
Experimental: HRS-7058 + BP102
Drug: HRS-7058 + BP102
HRS-7058 + BP102
Experimental: HRS-7058 + SHR-9839
Drug: HRS-7058 + SHR-9839
HRS-7058 + SHR-9839
Experimental: HRS-7058 +SHR-A2102 +SHR-1316
Drug: HRS-7058 +SHR-A2102 +SHR-1316
HRS-7058 +SHR-A2102 +SHR-1316
Experimental: HRS-7058 +SHR-9839(sc)+SHR-1316
Drug: HRS-7058 +SHR-9839(sc)+SHR-1316
HRS-7058 +SHR-9839(sc)+SHR-1316
Experimental: HRS-7058 +SHR-1316 +BP102
Drug: HRS-7058 +SHR-1316 +BP102
HRS-7058 +SHR-1316 +BP102
Experimental: HRS-7058 +SHR-A2102 +BP102
Drug: HRS-7058 +SHR-A2102 +BP102
HRS-7058 +SHR-A2102 +BP102
Experimental: HRS-7058 +SHR-A2102 +SHR-1316 +BP102
Drug: HRS-7058 +SHR-A2102 +SHR-1316 +BP102
HRS-7058 +SHR-A2102 +SHR-1316 +BP102

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Dose-limiting toxicity (DLT) (Dose Escalation and Dose Expansion)
Time Frame: From the beginning of first patient in (FPI) to the end of dose expansion phase up to approximately 10 months
From the beginning of first patient in (FPI) to the end of dose expansion phase up to approximately 10 months
Safety endpoints: adverse events (AE) (Dose Escalation and Dose Expansion)
Time Frame: From the beginning of first patient in (FPI) to the end of dose expansion phase up to approximately 10 months]
From the beginning of first patient in (FPI) to the end of dose expansion phase up to approximately 10 months]
Phase II recommended dose (RP2D)(Dose Escalation and Dose Expansion)
Time Frame: From the beginning of first patient in (FPI) to the end of dose expansion phase up to approximately 10 months]
From the beginning of first patient in (FPI) to the end of dose expansion phase up to approximately 10 months]
Efficacy endpoints: Objective response rate (ORR) assessed based on RECIST v1.1 criterion (Efficacy Expansion)
Time Frame: From the beginning of first patient in (FPI) to the end of study up to approximately 32 months
From the beginning of first patient in (FPI) to the end of study up to approximately 32 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Efficacy endpoints: Objective response rate (ORR) assessed based on RECIST v1.1 criterion (Dose Escalation and Dose Expansion)
Time Frame: From the beginning of first patient in (FPI) to the end of dose expansion phase up to approximately 10 months
From the beginning of first patient in (FPI) to the end of dose expansion phase up to approximately 10 months
Efficacy endpoints: disease control rate (DCR) assessed based on RECIST v1.1 criterion (Dose Escalation and Dose Expansion)
Time Frame: From the beginning of first patient in (FPI) to the end of dose expansion phase up to approximately 10 months
From the beginning of first patient in (FPI) to the end of dose expansion phase up to approximately 10 months
Efficacy endpoints: duration of response (DoR) assessed based on RECIST v1.1 criterion (Dose Escalation and Dose Expansion)
Time Frame: From the beginning of first patient in (FPI) to the end of dose expansion phase up to approximately 10 months
From the beginning of first patient in (FPI) to the end of dose expansion phase up to approximately 10 months
Efficacy endpoints: progression-free survival (PFS) assessed based on RECIST v1.1 criterion (Dose Escalation and Dose Expansion)
Time Frame: From the beginning of first patient in (FPI) to the end of dose expansion phase up to approximately 10 months
From the beginning of first patient in (FPI) to the end of dose expansion phase up to approximately 10 months
Efficacy endpoints: overall survival (OS)(Dose Escalation and Dose Expansion)
Time Frame: From the beginning of first patient in (FPI) to the end of dose expansion phase up to approximately 10 months
From the beginning of first patient in (FPI) to the end of dose expansion phase up to approximately 10 months
Efficacy endpoints: disease control rate (DCR) assessed based on RECIST v1.1 criterion (Efficacy Expansion)
Time Frame: From the beginning of first patient in (FPI) to the end of study up to approximately 32 months
From the beginning of first patient in (FPI) to the end of study up to approximately 32 months
Efficacy endpoints: duration of response (DoR) assessed based on RECIST v1.1 criterion (Efficacy Expansion)
Time Frame: From the beginning of first patient in (FPI) to the end of study up to approximately 32 months
From the beginning of first patient in (FPI) to the end of study up to approximately 32 months
Efficacy endpoints: progression-free survival (PFS) assessed based on RECIST v1.1 criterion (Efficacy Expansion)
Time Frame: From the beginning of first patient in (FPI) to the end of study up to approximately 32 months
From the beginning of first patient in (FPI) to the end of study up to approximately 32 months
Efficacy endpoints: overall survival (OS) (Efficacy Expansion)
Time Frame: From the beginning of first patient in (FPI) to the end of study up to approximately 32 months
From the beginning of first patient in (FPI) to the end of study up to approximately 32 months
Safety endpoints: adverse events (AE)(Efficacy Expansion)
Time Frame: From the beginning of first patient in (FPI) to the end of study up to approximately 32 months
From the beginning of first patient in (FPI) to the end of study up to approximately 32 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)

April 28, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

April 1, 2025

First Submitted That Met QC Criteria

April 1, 2025

First Posted (Actual)

April 8, 2025

Study Record Updates

Last Update Posted (Actual)

January 26, 2026

Last Update Submitted That Met QC Criteria

January 22, 2026

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HRS-7058-201

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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