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A Study on the Safety and Efficacy of LAE001 in the Treatment of Metastatic Prostate Cancer

NCT03843918 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2025-09-10

No results posted yet for this study

Summary

This study is a multicenter phase I/II study of the treatment of patients with metastatic prostate cancer. The objective of Phase I part is to study the safety and tolerability of LAE001 monotherapy in patients with metastatic castration-resistant prostate cancer, and determine the maximum tolerated dose (MTD) as well as the recommended phase II dose (RP2D) of the drug, the Phase II part is to assess the efficacy of LAE001 based on PSA in the treatment of patients with metastatic castration-resistant prostate cancer.

Conditions

  • Prostate Cancer Metastatic

Interventions

DRUG

LAE001

LAE001 BID will be orally administered until the subjects develop disease progression, intolerable adverse events, or trial withdrawal decided by the investigator/subject. The LAE001 dose adopted for the phase II study will be based on the RP2D determined in the phase I study.

Sponsors & Collaborators

  • Laekna Limited

    lead INDUSTRY

Principal Investigators

  • Dingwei Ye, MD · Fudan University Shanghai Cnacer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-05
Primary Completion
2023-10-09
Completion
2023-10-09

Countries

  • China

Study Locations

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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 NCT03843918 on ClinicalTrials.gov