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Folic Acid-Tubulysin Conjugate EC1456 In Patients With Advanced Solid Tumors

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2016 by Endocyte
Information provided by (Responsible Party):
Endocyte Identifier:
First received: November 26, 2013
Last updated: January 19, 2016
Last verified: January 2016
Phase 1, multicenter, open-label, non-randomized, dose-escalation oncology study to evaluate the administration of EC1456, BIW on Weeks 1 and 2 of a 3-week schedule (Part A), and to assess preliminary efficacy results in focused patients with triple-negative breast cancer (TNBC), advanced non-small cell lung cancer (NSCLC) and ovarian cancer treated at the MTD (Part B).

Condition Intervention Phase
Solid Tumors
Triple-Negative Breast Cancer (TNBC)
Advanced Non-Small Cell Lung Cancer (NSCLC)
Ovarian Cancer
Drug: EC1456 and etarfolatide (EC20)
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study of Folic Acid-Tubulysin Conjugate EC1456 In Patients With Advanced Solid Tumors

Resource links provided by NLM:

Further study details as provided by Endocyte:

Primary Outcome Measures:
  • Maximum Tolerated Dose (MTD) [ Time Frame: 18-24 months ]

Estimated Enrollment: 30
Study Start Date: October 2013
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Part A - MTD Drug: EC1456 and etarfolatide (EC20)


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Patients enrolled in Part A must receive the 99mTc- etarfolatide scan but they do not need to have FR-positive target lesions.

Parts A and B:

To qualify for enrollment, the following criteria must be met:

  • Patients must have the ability to sign an approved informed consent form (ICF).
  • Patients must be ≥ 18 years of age.
  • Patients must have histology confirmed metastatic or locally advanced solid tumor (preferably TNBC, NSCLC, ovarian, HCC) that has failed to respond to standard therapy, is not a candidate for standard therapy, or for which standard therapy does not exist.
  • Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Patients must have at least one measurable lesion per RECIST v1.1 criteria/Modified RECIST for HCC.
  • For the purpose of obtaining a RECIST v1.1 baseline scan, patients must have a radiological evaluation conducted no more than 28 days prior to beginning study therapy. Note: For patients with a history of CNS metastasis, baseline radiological imaging must include evaluation of the brain (MRI preferred or CT with contrast).
  • Patients must have recovered (to baseline/stabilization) from prior cytotoxic-therapy-associated acute toxicities.
  • Patients with prior radiation therapy are eligible if they meet the following criteria:

    1. Previous radiation therapy is allowed to <25% of the bone marrow (Cristy and Eckerman, 1987).
    2. Prior radiotherapy must be completed at least 2 weeks before patient begins study therapy.
    3. Patient must have recovered from the acute toxic effects of the treatment before beginning study therapy.
    4. Palliative for pain or symptom control must be completed at least one week before patient begins study therapy, and these lesions must be excluded as target and non-target lesions.
  • Patients must have adequate organ function:

    1. Bone marrow reserve: Absolute neutrophil count (ANC) ≥ 1.5 x 109/L. Platelets ≥ 100 x 109/L. Hemoglobin ≥ 9 g/dL.
    2. Cardiac:
  • Left ventricular ejection fraction (LVEF) equal to or greater than the institutional lower limit of normal. LVEF must be evaluated within 28 days prior to C1D1.
  • Cardiac Troponin I and T within normal limit. c) Hepatic: Total bilirubin ≤ 1.5 x the upper limit of normal (ULN). Alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ 3.0 x ULN OR ≤ 5.0 x ULN for patients with liver metastases.

    d) Renal: Serum creatinine ≤ 1.5 x ULN, or for patients with serum creatinine > 1.5 ULN, creatinine clearance ≥ 50 mL/min.

  • Patients of childbearing potential:

    1. All women of childbearing potential MUST have a negative serum pregnancy test within 1 week prior to the 99mTc-etarfolatide imaging procedure and within 1 week prior to treatment with EC1456.
    2. Women of child bearing potential must practice an effective method of birth control (e.g., oral, transdermal or injectable contraceptives, intrauterine device [IUD], or double-barrier contraception, such as diaphragm and spermicidal jelly) for the duration of their participation in the trial through 90 days following the last dose of EC1456.
    3. Male patients who are sexually active must practice an effective method of birth control (e.g., condom and spermicidal jelly). Effective birth control methods should be used throughout study participation and for at least 90 days following the last dose of EC1456.

Part B Only:

  • All patients in Part B must have TNBC, NSCLC or ovarian cancer.
  • All patients in Part B must have all target lesions FR-positive by 99mTc-etarfolatide scan.

All patients in Part B must fulfill all other initial inclusion criteria (except inclusion criterion 3).

Exclusion Criteria:

Parts A and B:

The presence of any of the following will exclude patients from the study:

  • More than 4 prior cytotoxic/biologics regimens for metastatic disease. Neoadjuvant and adjuvant treatments would not count towards this criterion (Note: hormonal therapy also would not count towards this criterion).
  • Chemotherapy, immunotherapy or biological therapy (including monoclonal antibodies) within 28 days prior to EC1456 administration.
  • Known hypersensitivity to the components of the study therapy or its analogs.
  • Carcinomatous meningitis and/or symptomatic central nervous system (CNS) metastases. Note: Asymptomatic patients with stable CNS metastatic lesions in CT or MRI scans in the last 6 months are eligible.
  • Malignancies that are expected to alter life expectancy or may interfere with disease assessment. Patients with adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, or low-grade (Gleason score ≤ 6) localized prostate cancer, ductal carcinoma in situ (DCIS) and patients with prior history of malignancy who have been disease free for more than 3 years are eligible.
  • Serious cardiac illness or medical conditions such as unstable angina, pulmonary embolism, or uncontrolled hypertension.
  • Anti-folate therapy such as methotrexate for rheumatoid arthritis.
  • Pregnant or lactating women.
  • Other concurrent chemotherapy, immunotherapy, radiotherapy, or investigational therapy.
  • Active infections (e.g., hepatitis or HIV carriers)

Part B Only:

All patients in Part B must have received no more than two prior chemotherapeutic regimens.

All patients in Part B must fulfill all other initial exclusion criteria (except exclusion criterion 1).

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01999738

Contact: Doria Schofield 317-608-0586

United States, Arizona
Scottsdale Healthcare Research Institute Recruiting
Scottsdale, Arizona, United States, 85258
Contact: Jasgit Sachdev, MD    480-323-1350   
Principal Investigator: Jasgit Sachdev, MD         
United States, Indiana
IU Health Goshen Center for Cancer Care Recruiting
Goshen, Indiana, United States, 46526
Contact: Alexander Starodub, MD    574-536-5462   
Contact: Vanessa DePue, RN    574-364-2649   
Principal Investigator: Alexander Starodub, MD         
Indiana University Cancer Center Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Daniela Matei, MD    317-944-0920      
Principal Investigator: Daniela Matei, MD         
Horizon BioAdvance Recruiting
Lafayette, Indiana, United States, 47905
Contact: Wael Harb, MD    765-446-5111      
Principal Investigator: Wael Harb, MD         
United States, Maryland
University of Maryland Recruiting
Baltimore, Maryland, United States, 21201-1595
Contact: Martin Edelman, MD    410-328-8708   
Principal Investigator: Martin Edelman, MD         
Sponsors and Collaborators
Study Director: Romnee Clark, MD Endocyte
  More Information

Responsible Party: Endocyte Identifier: NCT01999738     History of Changes
Other Study ID Numbers: EC1456-01
Study First Received: November 26, 2013
Last Updated: January 19, 2016

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Triple Negative Breast Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Breast Neoplasms
Breast Diseases
Skin Diseases
Folic Acid
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs processed this record on March 24, 2017