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Recruiting Phase 2 NCT07032077

A Clinical Trial of HRS-7058 Combined Anti-tumor Drugs in Subjects With Solid Tumors

Trial Parameters

Condition Solid Tumors
Sponsor Shandong Suncadia Medicine Co., Ltd.
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 100
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2025-07-09
Completion 2027-06
Interventions
HRS-7058

Brief Summary

This study aims to evaluate the safety and tolerability of HRS-7058 combined with antitumor drugs in subjects with solid tumors, and to determine the recommended dosage for Phase II. Evaluate the objective response rate of HRS-7058 in combination with anti-tumor drugs in subjects with solid tumors.

Eligibility Criteria

Inclusion Criteria: 1. Patients who are capable of giving informed consent, have signed the informed consent form approved by the IRB/EC and noted the date, and are willing and able to comply with the treatment plan, visits, various examinations, and other procedural requirements. 2. Age must be between 18 and 75 years old (inclusive) when signing the informed consent form, gender is unrestricted. 3. ECOG score of 0 or 1. 4. Expected survival period ≥ 12 weeks. 5. Provide 5-15 pieces of tumor tissue blocks fixed in formalin and embedded in paraffin, or unstained tumor specimen slices. The samples should be archived within the first 3 years before treatment or freshly obtained (freshly obtained is preferred). Slices do not need to be provided during the dose escalation phase. 6. According to the RECIST v1.1 standard, there must be at least one measurable lesion. 7. The functions of important organs meet the standards (no blood components or cell growth factors were used for corrective t

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