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

Sponsor
Zai Lab (Shanghai) Co., Ltd.
Study ID
NCT04178460
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Niraparib combined with MGD013 — DRUG
    The 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).

Study Details

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.

Key Dates

Start date
Feb 3, 2020
Status verified
May 2022
Primary completion
Mar 2, 2022
Completion
Mar 2, 2022

Study Design

Enrollment
60 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Assigned Interventions
    Niraparib combined with MGD013

Primary Outcome Measure

Safety and Validity profiles [ Time Frame: approximately 45months ]

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