This study is being conducted to assess the safety, tolerability, and efficacy of EDP1503 alone and in combination with pembrolizumab in patients with advanced metastatic colorectal carcinoma, triple-negative breast cancer, and checkpoint inhibitor relapsed tumors
This will be a Phase I/II open-label study which will involve a 2-week monotherapy with
EDP1503, following which the patients will be dosed with a combination of EDP1503 and
|Overal Status||Start Date||Phase||Study Type|
|Recruiting||December 19, 2018||Phase 1/Phase 2||Interventional|
Primary Outcome 1 - Measure: Safety and tolerability of EDP1503 alone and in combination with pembrolizumab as assessed per CTCAE v5.0
Primary Outcome 1 - Time Frame: 2 years
Primary Outcome 2 - Measure: Safety and tolerability of EDP1503 alone and in combination with pembrolizumab
Primary Outcome 2 - Time Frame: 2 years
Primary Outcome 3 - Measure: Evidence of anti-tumor activity of EDP1503 based on ORR
Primary Outcome 3 - Time Frame: 2 years
Selected Inclusion Criteria:
1. Subjects with histologically or cytologically confirmed advanced or metastatic solid
tumors who have had disease progression after treatment with all available therapies
for metastatic disease that are known to confer clinical benefit, or are intolerant to
treatment, or refuse standard treatment.
2. Have adequate organ function as defined in the clinical protocol. Specimens must be
collected within 10 days prior to the start of study treatment.
3. Have provided archival tumor tissue sample or newly obtained core or excisional biopsy
of a tumor lesion not previously irradiated.
4. Measurable disease by RECIST v1.1 as assessed by the local site
investigator/radiologist. Lesions situated in a previously irradiated area are
considered measurable if progression has been demonstrated in such lesions.
5. Metastatic disease not suitable for upfront curative-intent surgery.
6. Progressive disease on previous line of therapy per treating investigator (additional
specific criteria for cohort C).
7. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.
8. Additional tumor-specific inclusion criteria
Selected Exclusion Criteria:
1. Has received prior radiotherapy within 2 weeks of start of study treatment. Patients
must have recovered from all radiation-related toxicities, not require
corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted
for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.
2. Treatment with investigational therapy within 28 days prior to initiation of study
3. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with
an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g.,
CTLA-4, OX40, CD137) and was discontinued from that treatment due to a Grade 3 or
higher immune-related adverse event (irAE).
4. Has received prior systemic anti-cancer therapy within 28 days or 5 half-lives,
whichever is shorter prior to treatment.
Note: Patients must have recovered from all AEs due to previous therapies to ≤Grade 1
or baseline. Patients with ≤Grade 2 neuropathy may be eligible.
Note: If patient received major surgery, they must have recovered adequately from the
toxicity and/or complications from the intervention prior to starting study treatment.
5. Impaired cardiac function or clinically significant cardiac diseases, including any of
1. Unstable angina or acute myocardial infarction ≤ 3 months prior to C1D1;
2. Clinically significant heart disease (e.g., symptomatic congestive heart failure
[e.g., >NYHA Class 2]; uncontrolled arrhythmia, or hypertension; history of
labile hypertension or poor compliance with an antihypertensive regimen).
6. Uncontrolled active severe systemic infection requiring parenteral antibiotics within
1 week, and systemic antivirals or antifungals within two weeks prior to C1D1.
7. Patients with active CNS metastases and/or carcinomatous meningitis. Patients with
previously treated brain metastases may participate provided they are radiologically
stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging
(note that the repeat imaging should be performed during study screening), clinically
stable and without requirement of steroid treatment for at least 14 days prior to
first dose of study treatment.
8. Patients with severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its
9. Prior malignancies:
1. Patients with adequately resected basal or squamous cell carcinoma of the skin,
or adequately resected carcinoma in situ (i.e. cervix, breast) may enroll
irrespective of the time of diagnosis.
2. Patients with a known additional malignancy that is progressing or has required
active treatment within the past which may interfere with the interpretation of
the study. Cancer treated with curative intent < 5 years previously will not be
allowed unless approved by the Sponsor. Cancer treated with curative intent > 5
years previously and without evidence of recurrence will be allowed.
10. Patients with a diagnosis of immunodeficiency or receiving chronic systemic steroid
therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form
of immunosuppressive therapy within 7 days prior the first dose of study drug.
11. Patients with uncontrolled vomiting or dirrahea that could interfere with the GI
exposure to EDP1503.
12. Patients who are transfusion dependent should be discussed with the Medical Monitor
13. Patients unwilling to comply with the protocol including required biopsies and sample
collections required to measure disease.
14. Has active autoimmune disease that has required systemic treatment in the past 2 years
(i.e. with use of disease modifying agents, corticosteroids or immunosuppressive
drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid
replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a
form of systemic treatment.
15. Has received a live vaccine within 30 days of planned C1D1. Note: Examples of live
vaccines include, but are not limited to, the following: measles, mumps, rubella,
varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG),
and typhoid vaccine. Seasonal influenza vaccines for injection are generally
inactivated flu vaccines and are allowed. Intranasal influenza vaccines (e.g FluMist)
are live attenuated vaccines and are not allowed.
Minimum Age: 18 Years
Maximum Age: N/A
Healthy Volunteers: No
Name: Johanna Bendell, MD
Role: Principal Investigator
Affiliation: SCRI Development Innovations, LLC
|Florida Cancer Specialists
Sarasota, Florida 34232
|Stephenson Cancer Center
Oklahoma City, Oklahoma 73104
Nashville, Tennessee 37203