drugset / Trial / NCT06132217

A Study of Simmitinib Plus SG001 in Advanced Solid Tumors

NCT06132217

Phase 1/2 Not yet recruiting 168 enrolled Shanghai Runshi Pharmaceutical Technology Co., Ltd
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This is an open-label Phase I/II trial of simmitinib plus SG001 in patients with advanced solid tumors. Phase I will determine and confirm the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) for simmitinib in combination with SG001 in patients with advanced solid tumors. Phase 2 (Expansion) will evaluate the safety and efficacy of the combination in 3 cohorts at the RP2D from Phase I.

Timeline

Start
2024-01-30
Primary completion
2027-01-30
Completion
2027-01-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Enlonstobart Monoclonal antibody Intravenous
Subject Simmitinib Small molecule Oral

Indications