QUILT-3.017: Study of NEO-201 in Solid Tumors

  • End date
    Oct 15, 2022
  • participants needed
  • sponsor
    Precision Biologics, Inc
Updated on 23 January 2021
Cynthia Boyle
Primary Contact
National Cancer Institute (9.7 mi away) Contact
monoclonal antibodies
measurable disease
breast cancer
karnofsky performance status
lung cancer
neutrophil count
liver metastasis
chemotherapeutic agents
antineoplastic agents
solid tumour
pancreatic cancers
squamous cell lung cancer
monoclonal antibody neo-201


This is an open label, first-in-human, phase 1, dose escalation study to determine the safety including dose limiting toxicity (DLT) and maximal tolerated dose of the monoclonal antibody NEO-201 in adults with solid tumors (cancer) which has not responded to standard treatments.


The experimental drug called NEO-201 (the "study drug") is a monoclonal antibody that is being tested and is not approved for use in the United States by the FDA.

The primary purpose of this first in human targeted phase 1 open-label study with NEO-201 in subjects with advanced solid tumors is to determine the safety of NEO-201 and select a dose for phase 2 clinical trials.

NEO-201 will be given in four increasing doses to make sure it is safe. NEO-201 will start at a low dose (1 mg/kg) and be increased 3 times (2, 4, 6 mg/kg) over the period of the study in different groups of subjects. Subjects who enroll during the early stages of the study, will receive a lower dose of NEO-201, those who enroll later, will receive a higher dose that may be associated with more side effects.

Treatment NEO-201
Clinical Study IdentifierNCT03476681
SponsorPrecision Biologics, Inc
Last Modified on23 January 2021

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Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Adenocarcinoma of Lung or Pancreatic Cancer or Breast Cancer or Colorectal Cancer or Mucinous Carcinoma of Ovary or Squamous Cell Lung Cancer or Signe...?
Do you have any of these conditions: Signet Ring Cell Carcinoma of Ovary or Breast Cancer or breast carcinoma or Colon cancer; rectal cancer or cancer of the pancreas or colorectal neopla...?
Age: >/=18 years
Histologically or cytologically confirmed recurrent, locally advanced unresectable or metastatic cancer confirmed by the Laboratory of Pathology, NCI
Must have progressed after (or been intolerant of) standard therapy known to provide clinical benefit for respective tumor type and for which standard curative options do not exist or are no longer effective or tolerable
Must have archived tissue (10 unstained slides or tissue block), or must have tumor which can be safely biopsied percutaneously and be willing to undergo a tumor biopsy
Must have colorectal cancer, pancreatic cancer, adenocarcinoma of the lung, squamous cell lung cancer, breast cancer, and mucinous and signet cell ovarian cancer (cancer types in which tumor samples (> 50%) historically stain positive for NEO-201 expression)
Measurable disease (by RECIST)
ECOG </=2; or Karnofsky performance status of 50%
Laboratory Function: (within 21 days of the first dose of study drug)
Hemoglobin > 9 g/dL, or on stable doses (hematocrit stable within 1 gram and dose stable for one month) of erythropoietin or similar medication
Absolute neutrophil count (ANC) >/=1,500/mm3
Platelets >/=100,000/mm3
Total bilirubin </= 2.0 mg/dL
ALT and AST </= 3 times the ULN, or, if the subject has liver metastases, </= 5 times the ULN
Creatinine </= 1.5 mg/dL or creatinine clearance > 40 mL/min/1.73 m2 for subjects with creatinine levels above institutional normal
Voluntary written informed consent before performance of any study-related procedure that is not part of normal medical care
Prior Therapy
At least 14 days must have elapsed since treatment with oral tyrosine kinase inhibitors, or until toxicities associated with TKI therapy have resolved
At least 21 days must have elapsed since treatment with previous monoclonal antibodies, or until toxicities associated with mAb therapy have resolved
At least 4 weeks must have elapsed since any chemotherapeutic agents at the time of enrollment (or 6 weeks for regimens containing BCNU or mitomycin C)
At least 2 weeks must have elapsed since any systemic corticosteroids at the time of enrollment
At least 42 days after the completion of any type of immunotherapy, e.g. tumor vaccines
XRT: At least 7 days after local palliative XRT (small port)
Must have recovered from any acute toxicity related to prior therapy, except for alopecia. Toxicity should be grade 1, or grade 2 for peripheral neuropathy, or returned to baseline
Expected to be able to remain on a study protocol for at least 8 weeks
Females either post-menopausal, surgically sterilized, or willing to use acceptable methods of birth control for the duration of the study
Males must agree to use adequate contraception prior to the study, for the
duration of study participation, and 2 weeks after completion of NEO-201

Exclusion Criteria

History of disseminated or uncontrolled brain metastases or central nervous system disease. Brain metastases will be considered controlled if SD on two consecutive brain MRIs, performed at least 2 months apart, and subject is without seizures
History of allergic reactions attributed to compounds of similar chemical or biologic composition to NEO-201 or other agents used in this study
Any major surgery within 14 days of enrollment
Receiving any other investigational agents
No archival tissue available and a lesion(s) that cannot be safely biopsied via percutaneous route, or is unwilling to undergo biopsy
Has an uncontrolled concomitant illness including, but not limited to, ongoing or active infection, uncontrolled diabetes mellitus, symptomatic congestive heart failure, unstable angina pectoris, hypokalemia, family history of Long QT Syndrome or presence of cardiac arrhythmia
HIV-positive subjects on combination antiretroviral therapy are ineligible because of the unknown potential for pharmacokinetic interactions with NEO-201. In addition, these subjects are at increased risk of lethal infections which could complicate the toxicity assessment of this study. Appropriate studies will be undertaken in subjects receiving combination antiretroviral therapy when indicated
Subject has other serious medical illness, including a second malignancy, or psychiatric illness that could, in the Investigator's opinion, potentially interfere with the completion of treatment according to this protocol
Pregnant women are excluded from this study because the potential for teratogenic or abortifacient effects due to NEO-201 is unknown. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with NEO-201, breastfeeding should be discontinued if the mother is treated with NEO-201
Subjects with marked baselined prolongation of QT/QTc interval (e.g. 2 ECGs on separate dates demonstrating QTc interval > 450 ms)
Use of concomitant medications associated with a high risk of DtP and prolongation of QT/QTc interval
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