Clinical Trials /

A Study of JNJ-63898081 in Participants With Advanced Stage Solid Tumors

NCT03926013

Description:

The main purpose of this study are to determine the recommended Phase 2 dose (RP2D) regimen and the maximum tolerated dose, and to determine the safety of JNJ-63898081.

Related Conditions:
  • Prostate Adenocarcinoma
  • Renal Cell Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study of JNJ-63898081 in Participants With Advanced Stage Solid Tumors
  • Official Title: A Phase 1, First-in-Human, Dose Escalation Study of JNJ-63898081, in Subjects With Advanced Stage Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: CR108593
  • SECONDARY ID: 63898081EDI1001
  • NCT ID: NCT03926013

Conditions

  • Neoplasms

Interventions

DrugSynonymsArms
JNJ-63898081Part 1: Dose Escalation

Purpose

The main purpose of this study are to determine the recommended Phase 2 dose (RP2D) regimen and the maximum tolerated dose, and to determine the safety of JNJ-63898081.

Trial Arms

NameTypeDescriptionInterventions
Part 1: Dose EscalationExperimentalParticipants with metastatic castration-resistant prostate cancer (mCRPC) will receive JNJ-63898081. Ascending dose levels will be sequentially tested.
  • JNJ-63898081
Part 2: Dose ExpansionExperimentalParticipants with mCRPC or renal cell carcinoma (RCC) will receive JNJ-63898081 at the recommended Phase 2 dose (RP2D) determined in Part 1.
  • JNJ-63898081

Eligibility Criteria

        Inclusion Criteria:

          -  Histology: Part 1: Metastatic castration-resistant prostate cancer (mCRPC) with
             histologic confirmation of adenocarcinoma. Adenocarcinoma with small-cell or
             neuroendocrine features is allowed. mCRPC is defined by prostate Cancer Working Group
             (PCWG )3 criteria. Part 2: mCRPC as defined above or pathologically confirmed
             metastatic renal cell carcinoma (RCC) as defined by world health organization (WHO)
             2016 Classifications

          -  Measurable or evaluable disease: Part 1: Either measurable or evaluable disease for
             prostate cancer. Part 2: At least one measurable lesion as per RECIST v1.1.

          -  Evidence of disease progression on prior therapy that requires a new line of treatment

          -  Participants with accessible lesions enrolled in selected pharmacokinetic
             (PK)/pharmacodynamics (PD) cohorts and in Part 2 must agree to undergo the mandatory
             fresh tumor biopsies, unless collection of the biopsy presents a safety risk

        Exclusion Criteria:

          -  At least 2 weeks between prior anticancer treatment (including radiotherapy)
             discontinuation and the first dose of study drug, and toxicities have returned to
             Grade less than or equal to (<=) 1 or baseline

          -  Prior treatment with prostate-specific membrane antigen (PSMA)-targeted therapy except
             for PSMA-targeted vaccine is permitted

          -  Solid organ or bone marrow transplantation

          -  Seizure or known condition that may predispose to seizure or intracranial masses

          -  Other active malignancy requiring systemic treatment <=12 months prior to enrollment
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Part 1 and Part 2: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
Time Frame:Approximately 3 years
Safety Issue:
Description:An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.

Secondary Outcome Measures

Measure:Part 1 and Part 2: Serum Concentrations of JNJ-63898081
Time Frame:Approximately 3 years
Safety Issue:
Description:Serum samples will be analyzed to determine concentrations of JNJ-63898081 using a validated method.
Measure:Part 1 and 2: Systemic Cytokine Concentrations
Time Frame:Approximately 3 years
Safety Issue:
Description:A panel of cytokines, including those proinflammatory ones, will be measured.
Measure:Part 1 and 2: Concentration of Markers of T-Cell Activation
Time Frame:Approximately 3 years
Safety Issue:
Description:Markers of T-cell activation/exhaustion as well as immunophenotyping will be assessed.
Measure:Part 1 and 2: Number of Participants with JNJ-63898081 Antibodies
Time Frame:Approximately 3 years
Safety Issue:
Description:Anti-JNJ-63898081 antibodies will be evaluated in serum samples collected from all participants.
Measure:Serum Prostate Specific Antigen (PSA) Concentration
Time Frame:Approximately 3 years
Safety Issue:
Description:Serum prostate specific antigen (PSA) concentration will be assessed.
Measure:Percentage of JNJ-63898081 Receptor Occupancy
Time Frame:Approximately 3 years
Safety Issue:
Description:Percentage of JNJ-63898081 receptor occupancy will be assessed via flow cytometry.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Janssen Research & Development, LLC

Last Updated

September 12, 2019