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Phase 1 of EC1169 In Patients With Recurrent MCRPC

NCT02202447 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2019-02-07

No results posted yet for this study

Summary

The purpose of this study is to determine the safety of EC1169 and the best dose to use in humans in future studies. This study will also determine how EC1169 is distributed, broken down, passed and absorbed through your body and how quickly it is eliminated (leaves the body). All patients will receive EC1169.

As a secondary objective in Part A: To explore the relationships between baseline PSMA expression (tumor and patient level) as measured by 99mTc-EC0652 scans and the antitumor activity of EC1169.

As an exploratory objective in Part B: To assess EC0652 as a predictive biomarker for the efficacy of EC1169 by comparing PSMA-positive and PSMA-negative lesions for response.

Conditions

Interventions

DRUG

EC1169

PART A: EC1169 - Dose dependent on cohort, IV (in the vein) on days 1 and 8 of each 21 day cycle for the QW schedule. PART B: EC1169 cohort 1 - taxane naive - Recommended Phase 2 dose, IV (in the vein) on days 1 and 8 of each 21 day cycle for the QW schedule. PART B: EC1169 cohort 2 - taxane exposed - Recommended Phase 2 dose, IV (in the vein) on days 1 and 8 of each 21 day cycle for the QW schedule.

OTHER

EC0652

PART A AND B: EC0652 is in development as a radioimaging agent for PSMA-expressing tumors. All patients receive a baseline 99mTc-EC0652 SPECT/CT scan for PSMA expression prior to Cycle 1 Day 1.

Sponsors & Collaborators

  • Endocyte

    lead INDUSTRY

Principal Investigators

  • Alison Armour, MD · Endocyte

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2018-11-29
Completion
2018-11-29

Countries

  • United States

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 NCT02202447 on ClinicalTrials.gov