drugset / Trial / NCT04764084

Niraparib Combined With Anlotinib in Homologous Recombination Repair (HRR) Gene-mutated Advanced Solid Tumors

NCT04764084

Phase 1 Unknown 52 enrolled Peking University Cancer Hospital & Institute
NaSingle-groupOpen-labelTreatment

Summary

Homologous Recombination Repair (HRR) gene mutations can be detected in many solid tumors, patients with HRR gene mutations may benefit from PARP inhibitor. Antiangiogenic drugs can induce hypoxia and increase the sensitivity to PARP inhibitor. The combination of PARP inhibitor and antiangiogenic drug can play a synergistic anti-tumor role and achieve good efficacy in HRR gene-mutated tumors. The purpose of the study is to determine the dose limiting toxicity (DLT) and maximum tolerable dose (MTD) of Niraparib plus Anlotinib in HRR gene-mutated advanced solid tumors, and evaluate the safety and effectiveness of this combination therapy preliminarily.

Timeline

Start
2021-04-01
Primary completion
2021-11-01
Completion
2023-02-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Catequentinib Small molecule 12 mg Oral
Subject Niraparib Small molecule 100 mg Oral
Subject Niraparib Small molecule 200 mg Oral