drugset / Trial / NCT06682611

Safety and Efficacy of SYHA1813 Single Agent or in Combination With Different Regimens in Unresectable Locally Advanced or Metastatic Solid Tumors.

NCT06682611 ↗

Phase 1/2 Not yet recruiting 380 enrolled Shanghai Runshi Pharmaceutical Technology Co., Ltd
RandomizedParallel-groupOpen-labelTreatment

Summary

This is an open-label, multi-center, multi-cohort, phase Ib/II clinical trial, divided into 8 cohorts according to tumor types. Cohorts 1-4 are SYHA1813 combined with different regimens, including safety run-in stage and cohort expansion stage. Cohorts 5-8 are SYHA1813 monotherapy and only include the expansion cohorts. The primary objective was to evaluate the safety and efficacy of SYHA1813 single agent or in combination with different regimens in unresectable locally advanced or metastatic solid tumors.

Timeline

Start
2024-11-13
Primary completion
2026-11-13
Completion
2027-11-13

Drugs

EvaluationDrugModalityDoseRoute
Subject Everolimus Small molecule — —
Subject Regorafenib Small molecule — —
Subject SYHA1813 Unknown — —
Comparator Carboplatin Small molecule — —
Comparator Cisplatin Other / unclassified — —
Comparator Enlonstobart Monoclonal antibody — —
Comparator Etoposide Small molecule — —
Comparator HB1801 Unknown — —
Comparator Paclitaxel Small molecule — —

Indications

No indication recorded.