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A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of JNJ-63723283, an Anti-Programmed Cell Death (PD)-1 Monoclonal Antibody, as Monotherapy or in Combination With Erdafitinib in Japanese Participants With Advanced Solid Cancers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03547037
Recruitment Status : Recruiting
First Posted : June 6, 2018
Last Update Posted : December 6, 2019
Sponsor:
Information provided by (Responsible Party):
Janssen Pharmaceutical K.K.

Brief Summary:
The primary purpose of this study is to identify the recommended Phase 2 dose (RP2D) of JNJ-63723283 as a monotherapy (Phase 1a part) and to identify the RP2D of JNJ-63723283 when administered in combination with Erdafitinib (Phase 1b part).

Condition or disease Intervention/treatment Phase
Neoplasm Drug: JNJ-63723283 Drug: Erdafitinib Phase 1

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Study Type : Interventional
Estimated Enrollment : 21 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/1b Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of JNJ-63723283, an Anti-PD-1 Monoclonal Antibody, as Monotherapy or in Combination With Erdafitinib in Japanese Subjects With Advanced Solid Cancers
Actual Study Start Date : August 31, 2018
Estimated Primary Completion Date : June 8, 2020
Estimated Study Completion Date : March 24, 2021

Arm Intervention/treatment
Experimental: Phase 1a: JNJ-63723283 (Monotherapy)
Participants will receive monotherapy of JNJ-63723283 intravenously. The subsequent dose levels of JNJ-63723283 will be escalated using Bayesian logistic regression model (BLRM).
Drug: JNJ-63723283
JNJ-63723283 will be administered intravenously.

Experimental: Phase 1b: Erdafitinib Combination
Participants will receive erdafitinib in combination with JNJ-63723283 which will be escalated using BLRM.
Drug: JNJ-63723283
JNJ-63723283 will be administered intravenously.

Drug: Erdafitinib
Erdafitinib will be administered orally.




Primary Outcome Measures :
  1. Phase 1a and Phase 1b: Number of Participants with Dose Limiting Toxicity (DLT) [ Time Frame: Up to 6 weeks (maximum) ]
    The DLTs are based on drug-related adverse events and defined as any of the following events: Infusion-related reactions, non-hematologic toxicity of Grade 3 or higher, or certain hematologic toxicity.

  2. Phase 1a and Phase 1b: Severity of DLT as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) [ Time Frame: Up to 6 weeks (maximum) ]
    Severity of DLT will be graded by using NCI-CTCAE, version 4.03. Severity scale ranges from Grade 1 to Grade 5 with Grades as follows: Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Life-threatening), and Grade 5 (Death).


Secondary Outcome Measures :
  1. Phase 1b: Number of Participants with Adverse Events and Immune-Related Adverse Event (irAE) by Severity [ Time Frame: Approximately up to 3 years ]
    An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. Severity of Adverse Event will be graded by using NCI-CTCAE, version 4.03. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death) with Grades as follows: Grade 1 (Mild) Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Life threatening) and Grade 5 (Death).

  2. Phase 1a and Phase 1b: Number of Participants With Clinically Significant Changes in Vital Signs as a Measure of Safety and Tolerability [ Time Frame: Approximately up to 3 years ]
    Number of participants with clinically significant changes in the vital signs including blood pressure, pulse rate, and body temperature will be reported.

  3. Phase 1a and Phase 1b: Number of Participants With Clinical Laboratory Abnormalities as a Measure of Safety and Tolerability [ Time Frame: Approximately up to 3 years ]
    Number of participants with clinical laboratory abnormalities (clinical laboratory tests include the following: hematology panel, coagulation panel, serum chemistry panel, endocrine panel, serology and pregnancy test [women only]) will be reported.

  4. Phase 1a and Phase 1b: Number of Participants With ECG Abnormalities as a Measure of Safety and Tolerability [ Time Frame: Approximately up to 3 years ]
    Number of participants with electrocardiogram (ECG) abnormalities will be reported.

  5. Phase 1a and Phase 1b: Maximum Serum Concentration (Cmax) of JNJ-63723283 [ Time Frame: Approximately up to 3 years ]
    The Cmax is the maximum observed serum concentration.

  6. Phase 1a and Phase 1b: Serum Concentration Immediately Prior to the Next Drug Administration (Ctrough) of JNJ-63723283 [ Time Frame: Approximately up to 3 years ]
    Ctrough is the serum concentration immediately prior to the next drug administration of any dose other than the first dose in a multiple dosing regimen.

  7. Phase 1a and Phase 1b: Time to reach Maximum Observed serum Concentration (Tmax) of JNJ-63723283 [ Time Frame: Approximately up to 3 years ]
    The Tmax is defined as actual sampling time to reach maximum observed serum concentration.

  8. Phase 1a and Phase 1b: Area Under the Serum Concentration-Time Curve Between 2 Defined Sampling Points, (t1 and t2) (AUC[t1-t2]) of JNJ-63723283 [ Time Frame: Approximately up to 3 years ]
    The AUC(t1-t2) is the area under the serum concentration-time curve between 2 defined sampling points, t1 and t2.

  9. Phase 1a and Phase 1b: Elimination Half-Life (t1/2) of JNJ-63723283 [ Time Frame: Approximately up to 3 years ]
    T1/2 is the time measured for the serum concentration to decrease by 1 half to its original concentration.

  10. Phase 1a and Phase 1b: Total Systemic Clearance (CL) of JNJ-63723283 [ Time Frame: Approximately up to 3 years ]
    CL is a quantitative measure of the rate at which JNJ-63723283 is removed from the body.

  11. Phase 1a and Phase 1b: Volume of Distribution at Steady-State (Vss) of JNJ-63723283 [ Time Frame: Approximately up to 3 years ]
    Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution is the apparent volume of distribution at steady-state.

  12. Phase 1b: Cmax of Erdafitinib [ Time Frame: Approximately up to 3 years ]
    The Cmax is the maximum observed plasma concentration.

  13. Phase 1b: Ctrough of Erdafitinib [ Time Frame: Approximately up to 3 years ]
    Ctrough is the plasma concentration immediately prior to the next drug administration of any dose other than the first dose in a multiple dosing regimen.

  14. Phase 1a and Phase 1b: Number of Participants With Anti-JNJ 63723283 Antibodies [ Time Frame: Approximately up to 3 years ]
    Number of participants with anti-JNJ 63723283 antibodies will be assessed.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Radiographically, histologically, or cytologically confirmed advanced or refractory solid tumor(s) that is metastatic or unresectable, and previously received or was ineligible for standard treatment options
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Thyroid function laboratory values within normal range
  • A woman must be: a) Not of childbearing potential; b) Of childbearing potential and practicing a highly effective, preferably user-independent method of contraception (failure rate of less than (<) 1 percent (%) per year when used consistently and correctly) and agrees to remain on a highly effective method while receiving study intervention and continue for 5 months following discontinuation of JNJ-63723283 or 3 months following discontinuation of erdafitinib, whichever is longer. Especially participants receiving erdafitinib must agree to use two contraceptive methods and one must be user-independent method; c) Agree not to donate eggs (ova, oocytes), during the study and continue for 5 months following discontinuation of JNJ-63723283 or 3 months following discontinuation of erdafitinib, whichever is longer
  • A male participant must wear a condom when engaging in any activity that allows for passage of ejaculate to another person and must agree not to donate sperm for 5 months following discontinuation of JNJ-63723283 or 5 months following discontinuation of erdafitinib, whichever is longer

Exclusion Criteria:

  • Had prior treatment with an anti-Programmed cell death (PD)-1 antibody, anti-PD-L1 antibody or anti-PD-L2 antibody
  • History of or concurrent interstitial lung disease
  • Active autoimmune disease or a documented history of autoimmune disease that requires systemic steroids or immunosuppressive agents
  • Grade 3 or higher toxicity effects from previous treatment with immunotherapy
  • Has taken immunosuppressive doses of systemic medications, such as corticosteroids doses greater than (>) 10 milligram per day (mg/day) prednisolone or equivalent), within 2 weeks before the planned first dose of study drug

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03547037


Contacts
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Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com

Locations
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Japan
National Cancer Center Hospital Recruiting
Chuo-ku, Japan, 104-0045
National Cancer Center Hospital East Recruiting
Kashiwa, Japan, 277-8577
Sponsors and Collaborators
Janssen Pharmaceutical K.K.
Investigators
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Study Director: Janssen Pharmaceutical K.K., Japan Clinical Trial Janssen Pharmaceutical K.K.

Additional Information:
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Responsible Party: Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier: NCT03547037    
Other Study ID Numbers: CR108471
63723283LUC1002 ( Other Identifier: Janssen Pharmaceutical K.K., Japan )
First Posted: June 6, 2018    Key Record Dates
Last Update Posted: December 6, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Antibodies
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs