drugset / Trial / NCT04588324

Study of SHR2150 (TLR7 Agonist) in Combination With Chemotherapy Plus PD-1 or CD47 Antibody in Subjects With Unresectable/ Metastatic Solid Tumors

NCT04588324

Phase 1/2 Unknown 50 enrolled Chinese PLA General Hospital
Non-randomizedSequentialOpen-labelTreatment

Summary

This phase I/II trial aims to evaluate safety and efficacy of SHR2150 in combination with chemotherapy plus PD-1 or CD47 antibody in subjects with unresectable/ metastatic solid tumors. Patients will receive the combined regimen in 3-week treatment cycles. During the Phase 1 dose escalation portion of the trial, three oral doses of SHR2150 will be combined with intravenous administration of chemotherapy and PD-1 or CD47 antibody. In the Phase 2 dose expansion portion, patients will be treated with the Recommended Phase 2 Dose (RP2D) of SHR2150 in combination with chemotherapy plus PD-1 or CD47 antibody.

Timeline

Start
2020-10-10
Primary completion
2021-11-30
Completion
2022-11-30

Drugs

EvaluationDrugModalityDoseRoute
Subject SHR2150 Small molecule 2 mg Oral

Indications