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
- 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
1. Previous radiation therapy is allowed to <25% of the bone marrow (Cristy and
2. Prior radiotherapy must be completed at least 2 weeks before patient begins
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.
- 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
All patients in Part B must fulfill all other initial inclusion criteria (except inclusion
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
- 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
All patients in Part B must fulfill all other initial exclusion criteria (except exclusion
Minimum Eligible Age: 18 Years
Maximum Eligible Age: N/A
Eligible Gender: Both