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drugset / Trial / NCT04679038

A Trial of SHR-1701 in Combination With Famitinib in Patients With Advanced Solid Tumors

NCT04679038 ↗

Phase 1/2 Unknown 222 enrolled Jiangsu HengRui Medicine Co., Ltd.
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This is an open-label, multi-center study to evaluate the efficacy and safety of SHR-1701 in combination with famitinib in subjects with metastatic or locally advanced solid tumor. There are two parts of the study: combinational therapy part and monotherapy part. Phase I of combinational therapy part is to determine the recommended dose for Phase II (RP2D) for famitinib in the combined regimen, then efficacy and safety of SHR-1701 plus famitinib (RP2D) will be further evaluated in the following Phase II in cohorts 1/2/3, with simon's two-stage design. Meanwhile, efficacy and safety of famitinib will also be assessed in cohorts 4/5 in the monotherapy part.

Timeline

Start
2021-03-17
Primary completion
2022-12-01
Completion
2023-10-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Famitinib Small molecule — Oral
Subject Retlirafusp alfa Protein / enzyme biologic — Intravenous

Indications

cancer