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

Last updated: May 27, 2025
Sponsor: Shandong Suncadia Medicine Co., Ltd.
Overall Status: Active - Recruiting

Phase

2

Condition

Neoplasms

Treatment

HRS-7058 + Cetuximab

HRS-7058 + SHR-1316

HRS-7058 + SHR-1826 + SHR-1316

Clinical Study ID

NCT06915142
HRS-7058-201
  • Ages 18-75
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. The subjects gave informed consent to the study before participating in, andvoluntarily 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 byhistopathology;

  4. Having at least one evaluable or measurable lesion according to the solid tumourresponse 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 benegative; and they must not be lactating. Female subjects of childbearing potentialand male subjects whose partners are females of childbearing potential must agree tocomply with contraceptive requirements from the time of signing the informed consentform until 5 months after the last administration of the study drug (for malesubjects) or 8 months after the last administration of the study drug (for femalesubjects).

Exclusion

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 investigationaldrug;

  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 useof 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 studydrug;

  12. Women during pregnancy or lactation;

  13. Known allergies and contraindications to the investigational drug or any of itscomponents;

  14. According to the judgment of the investigator, there are any other circumstancesthat may increase the risks of participating in the study, interfere with the studyresults, or make the subjects unsuitable for participating in this study.

Study Design

Total Participants: 300
Treatment Group(s): 5
Primary Treatment: HRS-7058 + Cetuximab
Phase: 2
Study Start date:
April 28, 2025
Estimated Completion Date:
October 31, 2027

Connect with a study center

  • Tianjin Cancer Hospital

    Tianjin, Tianjin 300060
    China

    Active - Recruiting

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