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History of Changes for Study: NCT02829099
A Study of Safety, Pharmacokinetics and Pharmacodynamics of JNJ-64457107 in Participants With Advanced Stage Tumors
Latest version (submitted October 5, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 July 7, 2016 None (earliest Version on record)
2 July 27, 2016 Study Status, Contacts/Locations and Oversight
3 August 26, 2016 Study Status, Contacts/Locations and Eligibility
4 September 16, 2016 Study Status and Oversight
5 September 23, 2016 Recruitment Status, Contacts/Locations and Study Status
6 October 21, 2016 Study Status and Contacts/Locations
7 November 21, 2016 Contacts/Locations and Study Status
8 December 22, 2016 Contacts/Locations and Study Status
9 February 20, 2017 Study Status
10 March 20, 2017 Study Status and Contacts/Locations
11 March 31, 2017 Contacts/Locations, Oversight and Study Status
12 June 19, 2017 Outcome Measures, Oversight, Study Status, Contacts/Locations and Study Description
13 July 20, 2017 Study Status and Contacts/Locations
14 September 8, 2017 Study Status, Contacts/Locations and Study Description
15 September 14, 2017 Study Status
16 October 12, 2017 Study Status, Contacts/Locations and Oversight
17 December 6, 2017 Study Status and Contacts/Locations
18 February 28, 2018 Study Status
19 June 25, 2018 Study Status and Contacts/Locations
20 July 19, 2018 Contacts/Locations and Study Status
21 August 17, 2018 Contacts/Locations and Study Status
22 November 8, 2018 Study Status and Contacts/Locations
23 February 1, 2019 Study Status
24 March 28, 2019 Study Status
25 September 12, 2019 Study Status and Contacts/Locations
26 October 10, 2019 Study Status and Contacts/Locations
27 November 7, 2019 Study Status and Contacts/Locations
28 December 5, 2019 Recruitment Status, Contacts/Locations, Study Status and Study Design
29 February 13, 2020 Study Status
30 July 16, 2020 Study Status
31 November 5, 2020 Study Status
32 January 28, 2021 Study Status
33 June 17, 2021 Study Status
34 August 11, 2021 Study Status
35 August 30, 2021 Recruitment Status and Study Status
36 October 21, 2021 Oversight and Study Status
37 October 5, 2022 Study Status and Oversight
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Study NCT02829099
Submitted Date:  July 7, 2016 (v1)

Open or close this module Study Identification
Unique Protocol ID: CR108186
Brief Title: A Study of Safety, Pharmacokinetics and Pharmacodynamics of JNJ-64457107 in Participants With Advanced Stage Tumors
Official 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 IDs: 64457107CAN1001 [Janssen Research & Development, LLC]
2016-000969-23 [EudraCT Number]
Open or close this module Study Status
Record Verification: July 2016
Overall Status: Not yet recruiting
Study Start: September 2016
Primary Completion: January 2019 [Anticipated]
Study Completion: January 2019 [Anticipated]
First Submitted: July 7, 2016
First Submitted that
Met QC Criteria:
July 7, 2016
First Posted: July 12, 2016 [Estimate]
Last Update Submitted that
Met QC Criteria:
July 7, 2016
Last Update Posted: July 12, 2016 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Janssen Research & Development, LLC
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
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.
Detailed Description:
Open or close this module Conditions
Conditions: Advanced Solid Neoplasms
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 114 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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.
Drug: JNJ-64457107
JNJ-64457107 administered by IV infusion on Day 1 and 14 of a 28-day cycle.
Other Names:
  • ADC1013
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Incidence of dose-limiting toxicities (Part 1)
[ Time Frame: Up to 28 days ]

Dose-limiting toxicities will reviewed as a subset of adverse events that occur within the first 28 days of dosing and meet protocol-specified criteria.
2. Incidence of adverse events (Part 1 and 2)
[ Time Frame: From signing of informed consent form (ICF) until 30 days after last dose of study drug (approximately up to 29 Months) ]

Secondary Outcome Measures:
1. Overall response rate (ORR)
[ Time Frame: Disease assessment will continue until progression or lost to follow-up (approximately up to 29 months) ]

The ORR is the proportion of participants with confirmed best objective response of complete response (CR) or immune-related CR (irCR).
2. Duration of Response (DOR)
[ Time Frame: Disease assessment will continue until progression or lost to follow-up (approximately up to 29 months) ]

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.
3. Progression-free Survival (PFS)
[ Time Frame: Disease assessment will continue until progression or lost to follow-up (approximately up to 29 months) ]

PFS is defined as the time from first dose of JNJ-64457107 to progressive disease or death due to any cause, whichever occurs first.
4. Overall Survival (OS)
[ Time Frame: Disease assessment will continue until progression or lost to follow-up (approximately up to 29 months) ]

Overall survival is defined as the time from first dose of JNJ-64457107 to date of death from any cause.
5. Maximum observed serum concentration (Cmax) of JNJ-64457107
[ Time Frame: Cycle 1: 1 hour before end of infusion (EOI), 1, 4, 24 hours post EOI (Day 1), any time (Day 8), predose (Day 15);Cycle 2: predose (Day 1), 1 hour before EOI, 1, 4, 24 hours post EOI (Day 15), anytime (Day 22);Cycles 3, 4: predose; end of treatment visit ]

6. Time of maximum observed serum concentration (Tmax) of JNJ-64457107
[ Time Frame: Cycle 1: 1 hour before end of infusion (EOI), 1, 4, 24 hours post EOI (Day 1), any time (Day 8), predose (Day 15);Cycle 2: predose (Day 1), 1 hour before EOI, 1, 4, 24 hours post EOI (Day 15), anytime (Day 22);Cycles 3, 4: predose; end of treatment visit ]

The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
7. Area under the serum concentration versus time curve from time 0 to infinity (AUCinf) of JNJ-64457107
[ Time Frame: Cycle 1: 1 hour before end of infusion (EOI), 1, 4, 24 hours post EOI (Day 1), any time (Day 8), predose (Day 15);Cycle 2: predose (Day 1), 1 hour before EOI, 1, 4, 24 hours post EOI (Day 15), anytime (Day 22);Cycles 3, 4: predose; end of treatment visit ]

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.
8. Area under the serum concentration versus time curve from time 0 to the final quantifiable time point (t) [AUC(0-t)] of JNJ-64457107
[ Time Frame: Cycle 1: 1 hour before end of infusion (EOI), 1, 4, 24 hours post EOI (Day 1), any time (Day 8), predose (Day 15);Cycle 2: predose (Day 1), 1 hour before EOI, 1, 4, 24 hours post EOI (Day 15), anytime (Day 22);Cycles 3, 4: predose; end of treatment visit ]

9. Area under the serum concentration versus time curve during a dosing interval (AUCtau) of JNJ-64457107
[ Time Frame: Cycle 1: 1 hour before end of infusion (EOI), 1, 4, 24 hours post EOI (Day 1), any time (Day 8), predose (Day 15);Cycle 2: predose (Day 1), 1 hour before EOI, 1, 4, 24 hours post EOI (Day 15), anytime (Day 22);Cycles 3, 4: predose; end of treatment visit ]

10. Immunogenicity of JNJ-64457107 when administered IV
[ Time Frame: Cycle 1: 1 hour before end of infusion (EOI) on Day 1; Cycle 2: predose on Day 1; Cycles 3, 4: predose; end of treatment visit ]

Detection and characterization of antibodies to JNJ-64457107
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Documented radiologic or clinical tumor progression
  • 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
Open or close this module Contacts/Locations
Central Contact Person: This study is not yet recruiting patients. Please check back for future recruiting sites, or email
Email: JNJ.CT@sylogent.com
Study Officials: Janssen Research & Development, LLC Clinical Trial
Study Director
Janssen Research & Development, LLC
Locations: United States, Colorado
Aurora, Colorado, United States
United States, Indiana
Lafayette, Indiana, United States
United States, Pennsylvania
Pittsburgh, Pennsylvania, United States
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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