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A Study of Safety, Pharmacokinetics, Pharmacodynamics of JNJ-61610588 in Participants With Advanced Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2017 by Janssen Research & Development, LLC
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT02671955
First received: January 11, 2016
Last updated: March 31, 2017
Last verified: March 2017
  Purpose
The purpose of this study is to evaluate the safety and tolerability of JNJ-61610588 in participants with advanced cancer in order to determine a recommended Phase 2 dose (RP2D) for further evaluation in specific tumor types.

Condition Intervention Phase
Advanced Cancer
Drug: JNJ-61610588
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: An Open-label, First-in-Human, Phase 1 Study of the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-61610588, a Fully Human IgG1 Kappa Anti-VISTA (V-domain Ig Suppressor of T-cell Activation) Monoclonal Antibody, in Subjects With Advanced Cancer

Resource links provided by NLM:


Further study details as provided by Janssen Research & Development, LLC:

Primary Outcome Measures:
  • Frequency of Dose Limiting Toxicity (DLT) [ Time Frame: Approximately 2.5 years ]
    The Dose Limiting Toxicity (DLT) is based on adverse events and includes unacceptable hematologic toxicity, unacceptable non-hematologic toxicity of Grade 3 or higher, and treatment delay greater than 2 weeks.

  • Number of Participants with Adverse Events (AEs) and Serious AEs [ Time Frame: Approximately 2.5 years ]
    An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

  • Change From Baseline in Pharmacodynamic Blood Biomarkers- Total Blood Cell Counts [ Time Frame: Approximately 2.5 years ]
    Standard hematology laboratory tests will be used to evaluate total blood cell counts in blood samples collected pre- and posttreatment.

  • Change From Baseline in Pharmacodynamic Blood Biomarkers- Markers of Monocyte Activation [ Time Frame: Approximately 2.5 years ]
    Flow cytometry will be used to evaluate markers of monocyte activation in blood samples collected pre- and posttreatment.

  • Change From Baseline in Pharmacodynamic Blood Biomarkers- Markers of T Cell Activation [ Time Frame: Approximately 2.5 years ]
    Flow cytometry will be used to evaluate markers of T cell activation in blood samples collected pre- and posttreatment.

  • Change From Baseline in Pharmacodynamic Tissue Biomarkers- Protein Expression of VISTA (V-domain Ig suppressor of T cell activation) [ Time Frame: Approximately 2.5 years ]
    Pre- and posttreatment tissue samples will be stained by immunohistochemistry for protein expression of VISTA.

  • Change From Baseline in Pharmacodynamic Tissue Biomarkers- Markers Associated With Immune Infiltrate Including CD3, CD4, CD8, Forkhead box P3, CD68, and PD-L1. [ Time Frame: Approximately 2.5 years ]
    Pre- and posttreatment tissue samples will be stained by immunohistochemistry for markers associated with immune infiltrate including CD3, CD4, CD8, forkhead box P3, CD68, and PD-L1.


Secondary Outcome Measures:
  • Maximum Serum Concentration (Cmax) of JNJ-61610588 [ Time Frame: Approximately 2.5 years ]
    The Cmax is the maximum observed serum concentration of JNJ-61610588.

  • Elimination Half-Life (t1/2) [ Time Frame: Approximately 2.5 years ]
    The elimination half-life (t1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).

  • Area Under the Serum Concentration-Time Curve From t1 to t2 Time (AUC[t1-t2]) of JNJ-61610588 [ Time Frame: Approximately 2.5 years ]
    The AUC(t1-t2) is the area under the serum JNJ-61610588 concentration-time curve from time t1 to t2.

  • Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) [ Time Frame: Approximately 2.5 years ]
    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.

  • Number of Participants With Anti-JNJ-61610588 Antibodies [ Time Frame: Approximately 2.5 years ]
    Plasma levels of antibodies to JNJ-61610588 for evaluation of potential immunogenicity.

  • Assessment of Anti-Tumor Activity, as Assessed by the Overall Response Rate (ORR) [ Time Frame: Approximately 2.5 years ]
    Anti-tumour activity as assessed by the ORR based on Response Evaluation Criteria in Solid Tumours (RECIST), version 1.1.

  • Assessment of Anti-Tumor Activity, as Assessed by the Overall Response Rate (ORR) [ Time Frame: Approximately 2.5 years ]
    Anti-tumour activity as assessed by the ORR based on Immune-Related Response Criteria (irRC).

  • Assessment of Anti-Tumor Activity, as Assessed by Duration of Response [ Time Frame: Approximately 2.5 years ]
    Anti-tumour activity as assessed by the duration of response.


Estimated Enrollment: 124
Actual Study Start Date: January 27, 2016
Estimated Study Completion Date: August 23, 2019
Estimated Primary Completion Date: April 10, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Part 1: Dose Escalation
Participants with advanced solid tumors will receive intravenous infusions of JNJ-61610588 until disease progression. Dose escalation will continue until the maximum tolerated dose is reached.
Drug: JNJ-61610588
Participants will receive intravenous infusions of JNJ-61610588 until disease progression.
Experimental: Part 2: Biomarker Evaluation
Participants with metastatic Non-small Cell Lung Cancer (NSCLC) will receive intravenous infusion of JNJ-61610588 at or below the recommended Phase 2 dose (RP2D) until disease progression.
Drug: JNJ-61610588
Participants will receive intravenous infusions of JNJ-61610588 until disease progression.
Experimental: Part 3: Dose Expansion
Participants with metastatic Non-small Cell Lung Cancer (NSCLC) will receive intravenous infusion of JNJ-61610588 at the recommended Phase 2 dose (RP2D) until disease progression.
Drug: JNJ-61610588
Participants will receive intravenous infusions of JNJ-61610588 until disease progression.
Experimental: Part 4: Dose Expansion
Participants with advanced solid tumors will receive intravenous infusion of JNJ-61610588 at the recommended Phase 2 dose (RP2D) until disease progression.
Drug: JNJ-61610588
Participants will receive intravenous infusions of JNJ-61610588 until disease progression.

Detailed Description:
The purpose of this study is to see if JNJ-61610588 is safe and useful for treating participants with advanced cancer. This study consists of up to 4 parts. Part 1 will determine what dose of JNJ-61610588 can be given safely to advanced cancer participants. Part 2 will look at how participants with metastatic non-small cell lung cancer respond to a safe dose of JNJ-61610588. Parts 3 and 4 will test whether the dose of JNJ-61610588 identified in Part 1 is a safe and effective therapy for participants with specific types of advanced cancers (lung, pancreas, cervical, colorectal, head and neck). Participants will receive study drug in an outpatient setting. Participants safety will be monitored throughout the study.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The participant has a solid tumor. Parts 2 and 3 are limited to participants with non-small cell lung cancer. Part 4 is limited to participants with small cell lung, head and neck, pancreatic, colorectal, and cervical cancers
  • Tumor progression following at least one prior standard therapy
  • The participant has a radiographically measurable tumor. Evaluable disease is acceptable for Part 1 only
  • The participant is willing to consent to provide a tumor tissue sample (fresh biopsy) before (Parts 2 and 3) and after (Part 2 only) receiving the study drug
  • The participant is able to carry out daily life activities without difficulty
  • The participant does not have significant side effects from previous anti-cancer treatment
  • The participant has adequate organ and blood cell counts
  • Sexually active participants must use medically acceptable methods of contraception during the course of this study

Exclusion Criteria:

  • The participant has a history of major surgery or treatment other cancer therapy within 2-6 weeks before starting the study
  • The participant has an untreated brain tumor
  • Current severe, uncontrolled systemic disease including an ongoing, active infection requiring treatment with antibiotics
  • The participant has high blood pressure or diabetes that is not well-controlled with medication
  • History of clinically significant heart problems
  • History of severe side effects toimmunotherapy
  • The participant is pregnant, breastfeeding, or planning to become pregnant or father a child
  • Positive for Hepatitis B, Hepatitis C, or HIV
  • The participant has received anticoagulant therapy with the exception of aspirin within 1 week of starting the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02671955

Contacts
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: JNJ.CT@sylogent.com

Locations
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
United States, Pennsylvania
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111
United States, Tennessee
Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
United States, Wisconsin
Medical College Of Wisconsin Not yet recruiting
Milwaukee, Wisconsin, United States, 53226-3522
France
Institut Bergonié Not yet recruiting
Bordeaux, France, 33000
Centre Georges François Leclerc Not yet recruiting
Dijon, France, 21079
Hôpital de la Timone Not yet recruiting
Marseille, France, 13885
Institut Curie Not yet recruiting
Paris, France, 75005
Gustave Roussy Not yet recruiting
Villejuif, France, 94805
Spain
Hosp. Univ. Germans Trias I Pujol Not yet recruiting
Badalona, Spain, 8916
Hosp. Univ. Vall D Hebron Not yet recruiting
Barcelona, Spain, 08035
Hosp. Univ. Fund. Jimenez Diaz Not yet recruiting
Madrid, Spain, 28040
Hosp. Univ. Hm Sanchinarro Not yet recruiting
Madrid, Spain, 28050
Hosp. Virgen Del Rocio Not yet recruiting
Sevilla, Spain, 41013
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
  More Information

Additional Information:
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02671955     History of Changes
Other Study ID Numbers: CR108083
61610588LUC1001 ( Other Identifier: Janssen Research & Development, LLC )
2016-001903-22 ( EudraCT Number )
Study First Received: January 11, 2016
Last Updated: March 31, 2017

Studies a U.S. FDA-regulated Drug Product: Yes

Keywords provided by Janssen Research & Development, LLC:
Advanced Cancer
JNJ-61610588

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on April 21, 2017