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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02829099




Registration number
NCT02829099
Ethics application status
Date submitted
7/07/2016
Date registered
7/07/2016
Date last updated
19/07/2018

Titles & IDs
Public title
A Study of Safety, Pharmacokinetics and Pharmacodynamics of JNJ-64457107 in Participants With Advanced Stage Tumors
Scientific title
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
Secondary ID [1] 0 0
64457107CAN1001
Secondary ID [2] 0 0
CR108186
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Neoplasms 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - JNJ-64457107

Experimental: JNJ-64457107 - In Part 1, the first cohort will receive JNJ-64457107 at a starting dose of 75 microgram per kilogram (mcg/kg). The proposed treatment schedule is intravenous (IV) dosing every 14 days. JNJ-64457107 doses will be escalated following a modified Continual Reassessment Method (mCRM); the JNJ-64457107 dose will be increased by not more than half-logarithmical (3.2-fold) dose increments. Dose escalation will continue until the maximum tolerated dose (MTD) and/or RP2D of JNJ-64457107 are defined or the maximum-administered dose (MAD) has been reached. In Part 2, subjects will receive JNJ-64457107 at the RP2D and regimen determined in Part 1.


Treatment: Drugs: JNJ-64457107
JNJ-64457107 administered by IV infusion on Day 1 and 14 of a 28-day cycle.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of dose-limiting toxicities (Part 1) - Dose-limiting toxicities will be reviewed as a subset of adverse events that occur within the first 28 days of dosing and meet protocol-specified criteria.
Timepoint [1] 0 0
Up to 28 days
Primary outcome [2] 0 0
Incidence of adverse events (Part 1 and 2)
Timepoint [2] 0 0
From signing of informed consent form (ICF) until 30 days after last dose of study drug (approximately up to 29 Months)
Secondary outcome [1] 0 0
Overall response rate (ORR) - The ORR is the proportion of participants with confirmed best objective response of complete response (CR) or immune-related CR (irCR).
Timepoint [1] 0 0
Disease assessment will continue until progression or lost to follow-up (approximately up to 29 months)
Secondary outcome [2] 0 0
Duration of Response (DOR) - For participants who achieve CR or partial response (PR), DOR will be calculated as time from initial response of CR or PR to progressive disease or death due to underlying disease, whichever comes first.
Timepoint [2] 0 0
Disease assessment will continue until progression or lost to follow-up (approximately up to 29 months)
Secondary outcome [3] 0 0
Progression-free Survival (PFS) - PFS is defined as the time from first dose of JNJ-64457107 to progressive disease or death due to any cause, whichever occurs first.
Timepoint [3] 0 0
Disease assessment will continue until progression or lost to follow-up (approximately up to 29 months)
Secondary outcome [4] 0 0
Overall Survival (OS) - Overall survival is defined as the time from first dose of JNJ-64457107 to date of death from any cause.
Timepoint [4] 0 0
Disease assessment will continue until progression or lost to follow-up (approximately up to 29 months)
Secondary outcome [5] 0 0
Maximum observed serum concentration (Cmax) of JNJ-64457107
Timepoint [5] 0 0
Cycle 1 Day 1 and Cycle 2 Day 15: predose, 1, 4, 24, 48, 72 hours post end of infusion (EOI); any time (Cycle 1 Day 8 and Cycle 2 Day 22); predose (Cycle 1 Day 15 and Cycle 3 and 4); end of treatment
Secondary outcome [6] 0 0
Time of maximum observed serum concentration (Tmax) of JNJ-64457107 - The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
Timepoint [6] 0 0
Cycle 1 Day 1 and Cycle 2 Day 15: predose, 1, 4, 24, 48, 72 hours post end of infusion (EOI); any time (Cycle 1 Day 8 and Cycle 2 Day 22); predose (Cycle 1 Day 15 and Cycle 3 and 4); end of treatment
Secondary outcome [7] 0 0
Area under the serum concentration versus time curve from time 0 to infinity (AUCinf) of JNJ-64457107 - The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.
Timepoint [7] 0 0
Cycle 1 Day 1 and Cycle 2 Day 15: predose, 1, 4, 24, 48, 72 hours post end of infusion (EOI); any time (Cycle 1 Day 8 and Cycle 2 Day 22); predose (Cycle 1 Day 15 and Cycle 3 and 4); end of treatment
Secondary outcome [8] 0 0
Area under the serum concentration versus time curve from time 0 to the final quantifiable time point (t) [AUC(0-t)] of JNJ-64457107
Timepoint [8] 0 0
Cycle 1 Day 1 and Cycle 2 Day 15: predose, 1, 4, 24, 48, 72 hours post end of infusion (EOI); any time (Cycle 1 Day 8 and Cycle 2 Day 22); predose (Cycle 1 Day 15 and Cycle 3 and 4); end of treatment
Secondary outcome [9] 0 0
Area under the serum concentration versus time curve during a dosing interval (AUCtau) of JNJ-64457107
Timepoint [9] 0 0
Cycle 1 Day 1 and Cycle 2 Day 15: predose, 1, 4, 24, 48, 72 hours post end of infusion (EOI); any time (Cycle 1 Day 8 and Cycle 2 Day 22); predose (Cycle 1 Day 15 and Cycle 3 and 4); end of treatment
Secondary outcome [10] 0 0
Immunogenicity of JNJ-64457107 when administered IV - Detection and characterization of antibodies to JNJ-64457107
Timepoint [10] 0 0
Cycle 1: predose on Day 1; Cycle 2: predose on Day 1; Cycles 3, 4: predose; end of treatment visit

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [2] 0 0
Monash Health, Monash Medical Centre - Clayton
Recruitment hospital [3] 0 0
Gallipoli Medical Research Centre - Greenslopes
Recruitment hospital [4] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment postcode(s) [3] 0 0
4120 - Greenslopes
Recruitment postcode(s) [4] 0 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Colorado
Country [2] 0 0
United States of America
State/province [2] 0 0
Indiana
Country [3] 0 0
United States of America
State/province [3] 0 0
Massachusetts
Country [4] 0 0
United States of America
State/province [4] 0 0
Oregon
Country [5] 0 0
United States of America
State/province [5] 0 0
Pennsylvania
Country [6] 0 0
United States of America
State/province [6] 0 0
Utah
Country [7] 0 0
Belgium
State/province [7] 0 0
Brussel
Country [8] 0 0
Belgium
State/province [8] 0 0
Gent
Country [9] 0 0
Denmark
State/province [9] 0 0
Herlev
Country [10] 0 0
Israel
State/province [10] 0 0
Haifa
Country [11] 0 0
Israel
State/province [11] 0 0
Jerusalem
Country [12] 0 0
Israel
State/province [12] 0 0
Petach Tikva
Country [13] 0 0
Israel
State/province [13] 0 0
Tel Aviv
Country [14] 0 0
Spain
State/province [14] 0 0
Barcelona
Country [15] 0 0
Spain
State/province [15] 0 0
Madrid
Country [16] 0 0
Spain
State/province [16] 0 0
Pamplona
Country [17] 0 0
Spain
State/province [17] 0 0
Sevilla
Country [18] 0 0
Spain
State/province [18] 0 0
Valencia

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/show/NCT02829099
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
JNJ.CT@sylogent.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02829099