NCT02829099

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 Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2016

Longer than P75 for phase_1

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 7, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 12, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

September 21, 2016

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 29, 2021

Completed
Last Updated

October 6, 2022

Status Verified

October 1, 2022

Enrollment Period

4.8 years

First QC Date

July 7, 2016

Last Update Submit

October 5, 2022

Conditions

Advanced Solid Neoplasms

Outcome Measures

Primary Outcomes (2)

  • 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.

    Up to 28 days

  • Incidence of adverse events (Part 1 and 2)

    From signing of informed consent form (ICF) until 30 days after last dose of study drug (approximately up to 29 Months)

Secondary Outcomes (10)

  • Overall response rate (ORR)

    Disease assessment will continue until progression or lost to follow-up (approximately up to 29 months)

  • Duration of Response (DOR)

    Disease assessment will continue until progression or lost to follow-up (approximately up to 29 months)

  • Progression-free Survival (PFS)

    Disease assessment will continue until progression or lost to follow-up (approximately up to 29 months)

  • Overall Survival (OS)

    Disease assessment will continue until progression or lost to follow-up (approximately up to 29 months)

  • Maximum observed serum concentration (Cmax) of JNJ-64457107

    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

  • +5 more secondary outcomes

Study Arms (1)

JNJ-64457107

EXPERIMENTAL

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

Interventions

JNJ-64457107DRUG

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

Also known as: ADC1013
JNJ-64457107

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Unknown Facility

Haifa, Israel

Location

Unknown Facility

Jerusalem, Israel

Location

Unknown Facility

Tel Aviv, Israel

Location

Unknown Facility

Madrid, Spain

Location

Related Publications (2)

  • Andersson H, Sobti A, Jimenez DG, de Coana YP, Ambarkhane SV, Hagerbrand K, Smith KE, Lindstedt M, Ellmark P. Early Pharmacodynamic Changes Measured Using RNA Sequencing of Peripheral Blood from Patients in a Phase I Study with Mitazalimab, a Potent CD40 Agonistic Monoclonal Antibody. Cells. 2023 Sep 27;12(19):2365. doi: 10.3390/cells12192365.

    PMID: 37830579DERIVED

  • Moreno V, Perets R, Peretz-Yablonski T, Fourneau N, Girgis S, Guo Y, Hellemans P, Verona R, Pendas N, Xia Q, Geva R, Calvo E. A phase 1 study of intravenous mitazalimab, a CD40 agonistic monoclonal antibody, in patients with advanced solid tumors. Invest New Drugs. 2023 Feb;41(1):93-104. doi: 10.1007/s10637-022-01319-2. Epub 2022 Dec 20.

    PMID: 36538259DERIVED

MeSH Terms

Interventions

mitazalimab

Study Officials

  • Janssen Research & Development, LLC Clinical Trial

    Janssen Research & Development, LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2016

First Posted

July 12, 2016

Study Start

September 21, 2016

Primary Completion

July 1, 2021

Study Completion

July 29, 2021

Last Updated

October 6, 2022

Record last verified: 2022-10

Locations

IL(3)ES(1)