NCT04539496

A Phase I/II Study of XZP-3287 in Metastasis Solid Tumors

A Multicenter, Open-label Phase I/II Study of XZP-3287 in Metastasis Solid Tumors in China

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 402 (actual)
• Sponsor: Sihuan Pharmaceutical Holdings Group Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study includes single agent/combination dose exploration study and the phase II study. The primary purpose of the dose exploration study is to determine the maximum tolerated dose(MTD)/recommended phase II dose(RP2D) of XZP-3287 and assess its safety and preliminary efficacy in solid tumor patients. The phase II study aims to explore the efficacy and safety profiles of XZP-3287 as a single- agent in hormone receptor(HR) positive, human epidermal growth factor receptor 2(HER2) negative advanced breast cancer.

Conditions

• Metastasis Solid Tumors
• Advanced Breast Cancer

Interventions

Type	Name	Description
DRUG	XZP-3287	* 20-560 mg QD, oral * 240-480 mg BID, oral
DRUG	XZP-3287;Letrozole;Anastrozole;Fulvestrant	XZP-3287: 360 mg BID, oral; Letrozole: 2.5 mg QD, oral; Anastrozole: 1 mg QD, oral; Fulvestrant: 500 mg intramuscular injection on C1D1, C1D15, the first day of each subsequent cycle (28 days a cycle)
DRUG	XZP-3287	480 mg BID, oral

Timeline

• Start date: 2018-05-22
• Primary completion: 2023-07-31
• Completion: 2025-12-31
• First posted: 2020-09-07
• Last updated: 2024-09-19

Locations

1 site across 1 country: China