A Study of Safety, Pharmacokinetics and Pharmacodynamics of JNJ-64457107 in Participants With Advanced Stage Tumors



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:7/22/2018
Start Date:September 21, 2016
End Date:March 15, 2020
Contact:Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:
Email:JNJ.CT@sylogent.com

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A Phase 1, Open-Label Study of the Safety, Pharmacokinetics and Pharmacodynamics of JNJ-64457107, an Agonistic Human Monoclonal Antibody Targeting CD40 in Patients With Advanced Stage Solid Tumors

The primary purpose of the study is to determine the recommended Phase 2 dose (RP2D) and
schedule of JNJ-64457107 when administered intravenously (IV) to participants with advanced
stage solid tumors in Part 1 and to further characterize the safety of JNJ-64457107 when
administered IV to participants with non-small cell lung cancer (NSCLC), pancreatic cancer
and cutaneous melanoma in Part 2.

This study has 2 parts: Dose Escalation (part 1) and Dose Expansion (part 2) which are
conducted in 3 phases: Screening Phase (up to 28 days prior to first dose of study drug and
includes procedures like electrocardiogram [ECG], serum pregnancy test), Treatment phase
(continues until the completion of the End-of-Treatment Visit [30 days after last dose of
study drug]) and Post-treatment follow-up phase (continues until the participant has died, is
lost to follow-up, or has withdrawn consent or the study ends). In follow-up, participants
will continue to be monitored for survival status and subsequent cancer-related therapies
until the end of study. Additional bio-markers will be assessed, in an optional sub-study, to
define the impact of JNJ-64457107 on innate and adaptive immune responses in tumors. Safety
will be monitored throughout the study by Safety Evaluation Team (SET).

Inclusion Criteria:

- Part 1: advanced stage solid tumors; Part 2: non-small cell lung cancer (NSCLC),
pancreatic cancer and cutaneous melanoma

- Eastern cooperative oncology group (ECOG) performance score of 0 or 1

- Adequate organ function as defined in the protocol

- A woman of childbearing potential must have a negative highly sensitive serum
(beta-human chorionic gonadotropin [beta-hCG]) pregnancy test at Screening and a
negative urine pregnancy test prior to the first dose of study drug

- During the study and for at least 120 days after receiving the last dose of study
drug, in addition to the highly effective method of contraception, a man who is
sexually active with a woman of childbearing potential must agree to use a barrier
method of contraception (example [eg.], condom with spermicidal
foam/gel/film/cream/suppository), or who is sexually active with a woman who is
pregnant must use a condom

Exclusion Criteria:

- Malignancy other than the disease under study within 2 years before screening
(exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ
of the cervix, or malignancy that in the opinion of the investigator, with concurrence
with the sponsor's medical monitor, is considered cured with minimal risk of
recurrence)

- Symptomatic brain metastases; asymptomatic brain metastases are allowed provided that
they have been treated, have been stable for greater than (>) 6 weeks as documented by
radiographic imaging, and do not require prolonged (>14 days) systemic corticosteroid
therapy

- Treatment with any local or systemic anti-neoplastic therapy or investigational
anticancer agent within 14 days or 4 half-lives, whichever is longer, up to a maximum
wash-out period of 28 days prior to the initiation of study drug administration

- Toxicities from previous anti-cancer therapies have not resolved to baseline levels or
to Grade 1 or less except for alopecia and peripheral neuropathy

- Major surgery (eg., requiring general anesthesia) within 3 weeks before screening, or
will not have fully recovered from surgery, or has surgery planned during the time the
subject is expected to participate in the study
We found this trial at
8
sites
330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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4805 Northeast Glisan Street
Portland, Oregon 97213
(503) 215-1111
Providence Portland Medical Center We strive to give those we serve exceptional, compassionate health care...
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Aurora, Colorado 80045
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55 Fruit Street
Boston, Massachusetts 02114
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119-143 Missenden Road
Camperdown, 2050
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Lafayette, Indiana
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Lafayette, IN
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Pittsburgh, Pennsylvania 15232
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Salt Lake City, Utah 84112
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