Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT04539496
PHASE1/PHASE2

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

Sponsor: Sihuan Pharmaceutical Holdings Group Ltd.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

402

Start Date

2018-05-22

Completion Date

2025-12-31

Last Updated

2024-09-19

Healthy Volunteers

No

Interventions

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

Locations (1)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China