NCT04178460

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

Terminated Phase 1 Last updated 1 June 2022

What this trial tests

Phase 1 trial testing Niraparib combined with MGD013 in Gastric Cancer in 60 participants. Terminated before completion.

Timeline

3 February 2020

Primary endpoint
2 March 2022

2 March 2022

Quick facts

Lead sponsor	Zai Lab (Shanghai) Co., Ltd.
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	60
Start date	3 February 2020
Primary completion	2 March 2022
Estimated completion	2 March 2022
Sites	19 locations across China

Drugs / interventions tested

• Niraparib combined with MGD013 — full drug profile →

Conditions studied

• Gastric Cancer — all drugs for Gastric Cancer →
• Triple Negative Breast Cancer — all drugs for Triple Negative Breast Cancer →
• Biliary Tract Carcinoma — all drugs for Biliary Tract Carcinoma →
• Endometrial Carcinoma — all drugs for Endometrial Carcinoma →

Sponsor

Zai Lab (Shanghai) Co., Ltd. — full company profile →

Who can join

Adults 18 to 100, any sex, with Gastric Cancer or Triple Negative Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Recent advances in therapeutic strategies for triple-negative breast cancer.
   Li Y, Zhang H, Merkher Y, Chen L, et al · · 2022 · cited 643× · PMID 36038913 · DOI 10.1186/s13045-022-01341-0
2. Advances in synthetic lethality for cancer therapy: cellular mechanism and clinical translation.
   Topatana W, Juengpanich S, Li S, Cao J, et al · · 2020 · cited 128× · PMID 32883316 · DOI 10.1186/s13045-020-00956-5
3. Development of synthetic lethality in cancer: molecular and cellular classification.
   Li S, Topatana W, Juengpanich S, Cao J, et al · · 2020 · cited 82× · PMID 33077733 · DOI 10.1038/s41392-020-00358-6
4. The role of DNA damage repair (DDR) system in response to immune checkpoint inhibitor (ICI) therapy.
   Shi C, Qin K, Lin A, Jiang A, et al · · 2022 · cited 60× · PMID 36071479 · DOI 10.1186/s13046-022-02469-0
5. The state of the art of bispecific antibodies for treating human malignancies.
   Wang S, Chen K, Lei Q, Ma P, et al · · 2021 · cited 59× · PMID 34431224 · DOI 10.15252/emmm.202114291
6. Cutting-Edge: Preclinical and Clinical Development of the First Approved Lag-3 Inhibitor.
   Chocarro L, Bocanegra A, Blanco E, Fernández-Rubio L, et al · · 2022 · cited 57× · PMID 35954196 · DOI 10.3390/cells11152351
7. PARP inhibitors in gastric cancer: beacon of hope.
   Wang Y, Zheng K, Huang Y, Xiong H, et al · · 2021 · cited 42× · PMID 34167572 · DOI 10.1186/s13046-021-02005-6
8. Dynamic single-cell mapping unveils Epstein‒Barr virus-imprinted T-cell exhaustion and on-treatment response.
   Qiu MZ, Wang C, Wu Z, Zhao Q, et al · · 2023 · cited 35× · PMID 37735150 · DOI 10.1038/s41392-023-01622-1