Clinical and Pharmacokinetic Study of Humanized Anti-CD47 Antibody as Single Agent in Patients With Solid Tumors

• Register: ClinicalTrials.gov
• Last refreshed on: 7 September 2015
• Main ID: NCT02447354
• Date of registration: 10/05/2015
• Prospective Registration: No
• Primary sponsor: Clinical Cancer Hospital, Kyiv
• Public title: Clinical and Pharmacokinetic Study of Humanized Anti-CD47 Antibody as Single Agent in Patients With Solid Tumors ASSIST
• Scientific title: Clinical and Pharmacokinetic Study of Humanized Anti-CD47 Antibody as Single Agent in Patients With Advanced Solid Tumors (Phase I)
• Date of first enrolment: February 2011
• Target sample size: 25
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02447354
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

Ukraine

Contacts

• Name: Oleg Novikov, PhD

• Name: Oleg Novikov, PhD

• Name: Viktor Lanevskij, PhD
• Affiliation: Cancer Center

• Name: Andrej Petrov, MD
• Affiliation: Cancer Center

Key inclusion & exclusion criteria

Inclusion Criteria:

- BINDING ANALYSIS of GENE MUTATIONS AND IMMUNOHISTOCHEMICAL the STUDY (with data
expression, the amplification and methylation status of genes) FOR EACH PATIENT
INDIVIDUALLY (depending on diagnosis)

- Diagnosis of an advanced solid tumor malignancy or lymphoma (non-Hodgkin's or
Hodgkin's lymphoma).

- Histological or cytological evidence of malignancy.

- Advanced malignancy, metastatic or unresectable, that has recurred or progressed
following standard therapy or failed standard therapy; or for which no standard
therapy currently exists, or for which subject is not a candidate for, or is
unwilling to undergo, standard therapy.

- Disease that is currently not amenable to curative surgical intervention.

- ECOG performance status of 0-1. Subjects with performance status of 2 will be
considered only after discussion between the investigator and medical monitor.

- 21 years or older, of either sex, and of any race.

- Subject (and/or parent/guardian for subject who otherwise is unable to provide
independent consent, if acceptable to and approved by the site and/or site's IRB)
must be willing to give written informed consent and be able to adhere to dose and
visit schedules.

- Female subjects of childbearing potential must have negative pregnancy test within 5
days prior to first dose of study drug.

- Female subjects of childbearing potential and male subjects whose sexual partners are
of childbearing potential must agree to abstain from sexual intercourse or to use an
effective method of contraception during the study and for 60 days after the last
dose of AV-299 (formerly SCH 900105). Examples of effective methods of contraception
include, but are not limited to, oral contraceptives or double barrier methods such
as condom plus spermicide or condom plus diaphragm.

- Adequate hematologic function as evidenced by Hg = 9g/dL, WBC = 3000 per mm3, ANC =
1500 per mm3 and platelet count = 100,000 per mm3.

- Adequate hepatic function as evidenced by a serum bilirubin level =1.5 × ULN (except
with known Gilbert's Syndrome)

- Payment of charitable contributions may be required

Exclusion Criteria:

- Women who are breast-feeding, pregnant, or intend to become pregnant.

- Hematologic malignancies other than lymphoma

- Any of the following within 6 months prior to administration of study drug:

- Myocardial infarction (MI), severe /unstable angina pectoris, coronary/peripheral
artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident,
transient ischemic attack or seizure disorder.

- Serious and/or symptomatic active infection within 14 days prior to first dose of
study drug.

- Subjects who have asymptomatic or mild infection and taking a short course of
antibiotics (ie, UTI, bronchitis) may be allowed after discussion with the medical
monitor.

- Baseline QTc interval as follows per Bazett's formula: Females > 470 msec; Males >
450 msec.

- Persistent, unresolved CTCAE v3.0 Grade 2 or higher drug-related toxicity (except
alopecia, erectile dysfunction, hot flashes, and decreased libido) associated with
previous treatment.

- Inadequate recovery from any prior surgical procedure or major surgical procedure
performed within 4 weeks prior to administration of first dose or major surgery
within 3 weeks prior to first dose of study drug.

- Any other medical or psychiatric condition that, in the opinion of the investigator,
might interfere with the subject's participation in the trial or interfere with the
interpretation of trial results.

- Known Human Immunodeficiency Virus (HIV) infection or a known HIV-related malignancy.

- Known active hepatitis B or C.

- Radiotherapy within 3 weeks prior to first study drug administration.

- Inability to comply with the protocol requirements or participation in any other
clinical study.

- Any medications listed in the table on "Prohibited Medications".

- Active alcohol abuse.



Age minimum: 21 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Solid Tumors

Intervention(s)

Biological: Humanized high-chimeric Antibody CD47

Primary Outcome(s)

To evaluate the safety and tolerability of anti-CD47 antibody [Time Frame: Expected 5 weeks (with a possible stay in the hospital)]

Secondary Outcome(s)

Pharmacokinetics (PK) of application humanized high-chimeric antibodies CD47 [Time Frame: up to 3 months]

Secondary ID(s)

CCH -234801

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Cancer Centre of Monoclonal Therapy, LLC

Ukrainian Antitumor Center