NCT02202447

Phase 1 of EC1169 In Patients With Recurrent MCRPC

A Phase 1 Study of A Prostate-Specific Membrane Antigen Targeting-Tubulysin Conjugate EC1169 In Patients With Recurrent Metastatic, Castration-Resistant Prostate Cancer (MCRPC)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Endocyte · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a Phase 1, multicenter, open-label, non-randomized, oncology study to conducted in 2 parts. Part A is a dose-escalation phase to determine the Recommended Phase 2 (RP2) dose and the following : * Evaluate the administration of EC1169 QW on Weeks 1 and 2 of a 3-week schedule * Evaluate the safety and pharmacokinetic profile of EC1169 and EC0652 * To assess preliminary efficacy results in patients with metastatic, castration-resistant prostate cancer (mCRPC) who have progressed on abiraterone and/or enzalutamide, and previously treated with a taxane. The primary objective of Part B is to identify the radiographic progression-free survival (rPFS) in taxane-naïve and taxane-exposed PSMA-positive mCRPC patients receiving treatment with EC1169.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2014-05-01
• Primary completion: 2018-11-29
• Completion: 2018-11-29
• First posted: 2014-07-29
• Last updated: 2019-02-07

Locations

6 sites across 1 country: United States