NCT06915142

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Shandong Suncadia Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Malignant Tumour

Interventions

Type	Name	Description
DRUG	HRS-7058 + SHR-1316	HRS-7058 + SHR-1316
DRUG	HRS-7058 + SHR-1316 + Platinum-containing doublet chemotherapy	HRS-7058 + SHR-1316 + Platinum-containing doublet chemotherapy
DRUG	HRS-7058 + Cetuximab	HRS-7058 + Cetuximab
DRUG	HRS-7058 + SHR-1826	HRS-7058 + SHR-1826
DRUG	HRS-7058 + SHR-1826 + SHR-1316	HRS-7058 + SHR-1826 + SHR-1316
DRUG	HRS-7058 + SHR-A1202	HRS-7058 + SHR-A1202
DRUG	HRS-7058 + BP102	HRS-7058 + BP102
DRUG	HRS-7058 + SHR-9839	HRS-7058 + SHR-9839
DRUG	HRS-7058 +SHR-A2102 +SHR-1316	HRS-7058 +SHR-A2102 +SHR-1316
DRUG	HRS-7058 +SHR-9839(sc)+SHR-1316	HRS-7058 +SHR-9839(sc)+SHR-1316
DRUG	HRS-7058 +SHR-1316 +BP102	HRS-7058 +SHR-1316 +BP102
DRUG	HRS-7058 +SHR-A2102 +BP102	HRS-7058 +SHR-A2102 +BP102
DRUG	HRS-7058 +SHR-A2102 +SHR-1316 +BP102	HRS-7058 +SHR-A2102 +SHR-1316 +BP102

Timeline

• Start date: 2025-04-28
• Primary completion: 2026-12-01
• Completion: 2027-10-01
• First posted: 2025-04-08
• Last updated: 2026-01-26

Locations

2 sites across 1 country: China