Phase 1 of EC1169 In Patients With Recurrent MCRPC

NCT02202447 | Completed Phase 1

• 1 other identifier: EC1169-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 6

Brief 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

Prostate Cancer

Keywords

EC1169; prostate cancer; EC0652

Outcome Measures

Primary Outcomes (2)

• PART A: Maximum Tolerated Dose of EC1169

  Review to see if there are any (Dose Limiting Toxicities) seen in cycle 1.

  Patients will be followed for an anticipated 21 days for occurence of DLTs

• PART B:To identify the radiographic progression-free survival (rPFS) in taxane-naïve and taxane-exposed PSMA-positive mCRPC

  To identify the radiographic progression-free survival (rPFS) in taxane-naïve and taxane-exposed PSMA-positive mCRPC patients receiving treatment with EC1169.

  Patients will be followed until progression of disease or no longer clinically benefiting for an anticipated 27 weeks (9 cycles)

Secondary Outcomes (3)

• PART A: Safety/adverse event review

  Patients will be followed until progression of disease or unacceptable toxicity for an anticipated 12 weeks (4 cycles)

• PART B: To evaluate time to Prostate Cancer Clinical Trials Working Group 3 (PCWG3)-defined NLCB (no longer clinically benefiting)

  Patients will be followed until progression of disease or no longer clinically benefiting for an anticipated 27 weeks (9 cycles)

• PART B: To evaluate the median progression-free survival [defined as the time from C1D1 to an event (i.e., radiological or clinical progression or death)] for each cohort

  Patients will be followed until progression of disease or no longer clinically benefiting for an anticipated 27 weeks (9 cycles)

Study Arms (1)

EC1169

EXPERIMENTAL

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. PART A: EC1169 given as IV bolus QW on Weeks 1 and 2 of a 3 week cycle. Dose based on dose escalation plan starting with 0.2 mg/m2 PART B: EC1169 cohort 1 - taxane naive mCRPC patients that have progressed while receiving (or subsequent to receiving) abiraterone and/or enzalutamide but must not have previously received taxane-based systemic chemotherapy for mCRPC (previous treatment with six cycles of docetaxel for metastatic castration-sensitive prostate cancer (mCSPC) is permissible). PART B: EC1169 cohort 2 - taxane exposed mCRPC patients who have progressed while receiving (or subsequent to receiving) abiraterone and/or enzalutamide and who have progressed subsequent to receiving \> 2 cycles of a taxane-based regimen for mCRPC.

Drug: EC1169; Other: EC0652

Interventions

EC1169 DRUG

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.

EC1169

EC0652 OTHER

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.

EC1169

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have the ability to sign an approved informed consent form (ICF).
• Patients must be ≥ 18 years of age.
• Patients must have histological, pathological and/or cytological confirmation of prostate cancer.
• Patients must have progressive, metastatic, castration-resistant prostate cancer (mCRPC) as defined below:
• Documented progressive metastatic CRPC will be based on at least one of the following criteria:
• PSA progression defined as 25% increase over baseline value with an increase in the absolute value of at least 2 ng/mL that is confirmed by another PSA level with a minimum of a 1 week interval and a minimum PSA of 2 ng/mL.
• Soft-tissue progression defined as an increase ≥ 20% in the sum of the longest diameter (LD) of all target lesions based on the smallest sum LD since treatment started or the appearance of one or more new lesions.
• Progression of bone disease (evaluable disease) or (new bone lesion(s)) by bone scan.
• Patients must have prior and/or ongoing androgen-deprivation therapy and a castrate level of serum testosterone (\<50 ng/dL).
• Patients must have progressed on abiraterone and/or enzalutamide.
• Patients must have been previously treated with a taxane except in cases of contraindication (e.g. poor performance status, age or patient choice)
• Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Patients must have at least one measurable lesion that can be followed for response assessment on baseline imaging obtained no more than 28 days prior to beginning study therapy. Baseline and follow up radiological disease assessment must include bone scans performed with either Technetium-99m labeled diphosphonates or Fluorine-18 sodium fluoride PET or PET/CT, as per the local standard of care for patients with prostate cancer.
• Patients with CNS metastases that are symptomatic must have received therapy (surgery, XRT, gamma knife) and be neurologically stable and off of steroids. The patient should be off steroids at least 14 days before pre-registration. Asymptomatic CNS metastatic disease without associated edema, shift, requirement for steroids or anti-seizure medications are eligible after discussion with the sponsor medical monitor. For patients with a history of CNS metastasis, baseline and subsequent radiological imaging must include evaluation of the brain (MRI preferred or CT with contrast)
• Patients must have recovered (to baseline/stabilization) from prior therapy-associated acute toxicities.

You may not qualify if:

• More than 3 prior systemic anti-cancer therapies (e.g. cytotoxic agents, biologic agents) regimens for metastatic disease
• Previous treatment with Samarium-153 or Strontium-89.
• Any systemic anti-cancer therapy (e.g. chemotherapy, immunotherapy or biological therapy \[including monoclonal antibodies\]) within 28 days prior to beginning study therapy.
• Known hypersensitivity to the components of the study therapy or its analogs.
• Carcinomatous meningitis and/or symptomatic central nervous system (CNS) metastases.
• Malignancies that are expected to alter life expectancy or may interfere with disease assessment. Patients with adequately treated non-melanoma skin cancer and patients with prior history of malignancy who have been disease free for more than 3 years are eligible.
• Neuropathy CTCAE grade \> 2
• QTc interval of \> 480 ms.
• History of ischemic cardiac disease that has occurred within 6 months prior to study entry.
• Any other serious cardiac illness or medical conditions such as unstable angina, pulmonary embolism, or uncontrolled hypertension.
• Other concurrent chemotherapy, immunotherapy, radiotherapy, or investigational therapy.
• Active uncontrolled infections
• Known active Hepatitis B or C infections
• To qualify for enrollment, the following criteria must be met:
• Patients must have the ability to understand, and have signed an approved ICF

Sponsors & Collaborators

• Endocyte: lead

Study Sites (6)

Scottsdale Healthcare Clinical Trials at the Virginia G. Piper Cancer Center

Scottsdale, Arizona, 85258, United States

Location

Yale Cancer Center

New Haven, Connecticut, 06520, United States

Location

Tulane Cancer Center

New Orleans, Louisiana, 70112, United States

Location

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89169, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10017, United States

Location

South Texas Accelerated Research Therapeutics

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Alison Armour, MD

  Endocyte

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2014
• First Posted: July 29, 2014
• Study Start: May 1, 2014
• Primary Completion: November 29, 2018
• Study Completion: November 29, 2018
• Last Updated: February 7, 2019

Record last verified: 2019-02

Locations

US (6)