NCT04679038

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

SHR-1701 Plus Famitinib Malate in Advanced Solid Tumors: An Open-label, Multi-center, Phase I/II Trial

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 222 (estimated)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
BIOLOGICAL	SHR-1701	Intravenous (IV) on Day 1 of each cycle
DRUG	Famitinib	Famitinib, po, qd

Timeline

• Start date: 2021-03-17
• Primary completion: 2022-12-01
• Completion: 2023-10-01
• First posted: 2020-12-22
• Last updated: 2022-01-26

Locations

16 sites across 1 country: China