A Study of Niraparib Combined With MGD013 in Patients With Advanced or Metastatic Solid Tumor Who Failed Prior Treatment

Summary

This is a a Multicenter, Open-label, Single-arm, Phase Ib Dose Escalation and Multi-cohort Expansion Clinical Study to Assess the Safety and Antitumor Activity of Niraparib in Combination with MGD013 in Patients with Advanced or Metastatic Solid Tumor Who Failed Prior Treatment. This study consists of dose escalation part and dose expansion part.'3+3'design will be adopted in the dose escalation part in subjects with advanced or metastatic gastric cancer who failed prior treatment. The dose of niraparib will be fixed and determined based on baseline weight and platelet count of subjects. Dose expansion part will be expanded at the specified dose level to further assess the safety and preliminary antitumor activity.

Timeline

Start

2020-02-03

Primary completion

2022-03-02

Completion

2022-03-02

Publications

• Qiu MZ, Pan H, Lam KO, Wang J, Zheng Y, Li H, Wu X, Wang L, Bao L, Cheng J, Shi Y, Gao Y, Yan M, Luo H, Zheng Y, Zhen X, Hang W, Hou J, Xu RH. Tebotelimab plus niraparib in previously treated locally advanced or metastatic solid tumors: A phase 1b dose escalation and expansion study. Cancer. 2025 Jun 1;131(11):e35919. doi: 10.1002/cncr.35919.

Drugs

Indications