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

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Brief Title

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

Official Title

Phase 1 With Expansion Cohorts in a Study of NEO-201 in Adults With Chemo-Resistant Solid Tumors

Brief Summary

      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.
    

Detailed Description

      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.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Determine Maximum Tolerated Dose (MTD), 2 weeks after 2 doses of intravenous NEO-201 given every 2 weeks.

Secondary Outcome

 Toxicities including treatment emergent adverse events and the character and incidence of Grade 1-4 toxicities.

Condition

Colorectal Cancer

Intervention

NEO-201

Study Arms / Comparison Groups

 NEO-201
Description:  Subjects will receive the assigned dose of NEO-201 intravenously, once every 2 weeks for a total of 4 doses (57 days). This course will be repeated in the absence of disease progression or unacceptable toxicity.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

35

Start Date

January 18, 2019

Completion Date

October 15, 2022

Primary Completion Date

October 15, 2020

Eligibility Criteria

        Inclusion Criteria:

          -  Age: >/=18 years

          -  Diagnosis:

               -  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  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  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 administration.

        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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Christina M Annunziata, MD,PhD, 240-760-6006, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03476681

Organization ID

PB-1801


Responsible Party

Sponsor

Study Sponsor

Precision Biologics, Inc


Study Sponsor

Christina M Annunziata, MD,PhD, Principal Investigator, National Cancer Institute (NCI)


Verification Date

August 2019