Clinical Trials Directory

Trials / Terminated

TerminatedNCT04178460

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

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

Status
Terminated
Phase
Phase 1
Study type
Interventional
Enrollment
60 (actual)
Sponsor
Zai Lab (Shanghai) Co., Ltd. · Industry
Sex
All
Age
18 Years – 100 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGNiraparib combined with MGD013The dose escalation part will enroll about 9 - 24 Gastric cancer (including gastroesophageal junction cancer) subjects, with fixed dose niraparib (200mg or 300mg) combined with MGD013 (120mg, 300mg or 600mg ) in different dose level. For the dose expansion part, patients with advanced or metastatic Gastric cancer (including gastroesophageal junction cancer), Triple negative breast cancer, Biliary tract carcinoma, Endometrial carcinoma will be enrolled, about 35 subjects for each expansion cohort during dose expansion phase with fixed dose niraparib (200mg or 300mg) combined with fixe dose MGD013 (to be confirmed after dose escalation).

Timeline

Start date
2020-02-03
Primary completion
2022-03-02
Completion
2022-03-02
First posted
2019-11-26
Last updated
2022-06-01

Locations

19 sites across 1 country: China

Source: ClinicalTrials.gov record NCT04178460. Inclusion in this directory is not an endorsement.