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

Last updated: April 25, 2025
Sponsor: Janssen Pharmaceutical K.K.
Overall Status: Completed

Phase

1

Condition

Cancer

Carcinoma

Treatment

Erdafitinib

JNJ-63723283

Clinical Study ID

NCT03547037
CR108471
63723283LUC1002
  • Ages > 20
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Radiographically, histologically, or cytologically confirmed advanced or refractorysolid tumor(s) that is metastatic or unresectable, and previously received or wasineligible for standard treatment options. Participants with solid tumor(s) forwhich anti-PD-1 or anti-PD-L1 antibody as a monotherapy is approved in Japan areeligible.

  • 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 andpracticing a highly effective, preferably user-independent method of contraception (failure rate of less than (<) 1 percent (%) per year when used consistently andcorrectly) and agrees to remain on a highly effective method while receiving studyintervention and continue for 5 months following discontinuation of JNJ-63723283 or 3 months following discontinuation of erdafitinib, whichever is longer. Especiallyparticipants receiving erdafitinib must agree to use two contraceptive methods andone must be user-independent method; Examples of highly effective contraceptivesinclude: user-independent methods: intrauterine device (IUD) or intrauterinecontraceptive system (IUS) and user-dependent methods: combined (estrogen- andprogestogen-containing) hormonal contraception or progesterone-containing hormonalcontraception. c) Agree not to donate eggs (ova, oocytes), during the study andcontinue for 5 months following discontinuation of JNJ-63723283 or 3 monthsfollowing discontinuation of erdafitinib, whichever is longer

  • A male participant must wear a condom when engaging in any activity that allows forpassage of ejaculate to another person and must agree not to donate sperm for 5months following discontinuation of JNJ-63723283 or 5 months followingdiscontinuation of erdafitinib, whichever is longer

Exclusion

Exclusion Criteria:

  • Had prior treatment with an anti-PD-1 antibody, anti-PD-L1 antibody or anti-PDL2antibody within 30 days of first study drug administration and/or has an ongoingGrade 2 or higher immunotherapy-related toxicity. If the subject has an experienceof treatment with these agents, the subject must not have had severeimmunotherapy-related toxicity

  • History of or concurrent interstitial lung disease

  • Active autoimmune disease or a documented history of autoimmune disease thatrequires 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 corticosteroidsdoses greater than (>) 10 milligram per day (mg/day) prednisolone or equivalent),within 2 weeks before the planned first dose of study drug

Study Design

Total Participants: 22
Treatment Group(s): 2
Primary Treatment: Erdafitinib
Phase: 1
Study Start date:
August 31, 2018
Estimated Completion Date:
July 04, 2022

Connect with a study center

  • National Cancer Center Hospital

    Chuo Ku, 104 0045
    Japan

    Site Not Available

  • National Cancer Center Hospital

    Chuo-Ku, 104-0045
    Japan

    Site Not Available

  • National Cancer Center Hospital East

    Kashiwa, 277 8577
    Japan

    Site Not Available

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