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.