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

NCT04539496 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 402

Last updated 2024-09-19

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Sihuan Pharmaceutical Holdings Group Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-22
Primary Completion
2023-07-31
Completion
2025-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04539496 on ClinicalTrials.gov