Clinical Trials /

A Study of JNJ-70218902 in Participants With Advanced Stage Solid Tumors

NCT04397276

Description:

The purpose of this study is to determine the recommended Phase 2 dose(s) (RP2D[s]) and maximum tolerated dose (MTD) of JNJ-70218902 in Part 1, and to determine the safety of JNJ-70218902 RP2D(s) in Part 2.

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study of JNJ-70218902 in Participants With Advanced Stage Solid Tumors
  • Official Title: A Phase 1 Study of JNJ-70218902, a T Cell Redirecting Agent, in Advanced Stage Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: CR108765
  • SECONDARY ID: 2019-004885-16
  • SECONDARY ID: 70218902EDI1001
  • NCT ID: NCT04397276

Conditions

  • Neoplasms

Interventions

DrugSynonymsArms
JNJ-70218902Part 1: Dose Escalation

Purpose

The purpose of this study is to determine the recommended Phase 2 dose(s) (RP2D[s]) and maximum tolerated dose (MTD) of JNJ-70218902 in Part 1, and to determine the safety of JNJ-70218902 RP2D(s) in Part 2.

Detailed Description

      JNJ-70218902, the investigational drug, has been shown in pre-clinical studies to work by
      attaching to cancer cells and activating immune cells to kill these cancer cells.This study
      will be conducted in 2 parts: dose escalation (Part 1) and dose expansion (Part 2) and will
      enroll adult men with Metastatic Castration-Resistant Prostate Cancer (MCRPC). Study
      evaluations will include safety, pharmacokinetics, biomarkers and immunogenicity evaluations.
      This study is divided into 3 periods: screening, treatment and post-treatment. The total
      duration of the study will be 2.5 years approximately.
    

Trial Arms

NameTypeDescriptionInterventions
Part 1: Dose EscalationExperimentalParticipants with metastatic castration-resistant prostate cancer (mCRPC) will receive JNJ-70218902. The dose levels will be escalated sequentially based on the decisions of the Study Evaluation Team (SET) until the recommended Phase 2 Dose (RP2D) has been identified.
  • JNJ-70218902
Part 2: Dose ExpansionExperimentalParticipants with mCRPC will receive JNJ-70218902 at the RP2D determined in Part 1.
  • JNJ-70218902

Eligibility Criteria

        Inclusion Criteria:

          -  Histology: Metastatic castration-resistant prostate cancer (mCRPC) with histologic
             confirmation of adenocarcinoma. Adenocarcinoma with small-cell or neuroendocrine
             features is allowed

          -  Measurable or evaluable disease

          -  Prior treatment with at least 1 prior novel androgen receptor (AR)-targeted therapy or
             chemotherapy

          -  If the participant is receiving treatment with gonadotropin-releasing hormone agonists
             or antagonist analogs (GnRH), this therapy must have been initiated prior to first
             dose of study drug and must be continued throughout the study

          -  Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1

          -  Adequate organs functions

          -  Archived tissue at baseline are requested

          -  Participants with accessible lesions enrolled in selected cohorts in Part 1 and 2 will
             undergo fresh tumor biopsies

        Exclusion Criteria:

          -  Known brain metastases

          -  Concurrent use of any other anticancer treatment or investigational agent for the
             treatment of advanced disease

          -  Toxicities related to prior anticancer treatments have not returned to Grade less than
             or equal to (<=) 1 or baseline, except for alopecia and vitiligo

          -  Solid organ or bone marrow transplantation

          -  Known allergies, hypersensitivity, or intolerance to JNJ-70218902 or its excipients

          -  Certain comorbidities
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Male
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:Up to 2.5 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:Maximum Observed Serum Concentration (Cmax) of JNJ-70218902
Time Frame:Up to 2.5 years
Safety Issue:
Description:Cmax is the maximum observed serum concentration of JNJ-70218902.
Measure:Time to Reach Maximum Observed Serum Concentration (Tmax) of JNJ-70218902
Time Frame:Up to 2.5 years
Safety Issue:
Description:Tmax is defined as time to reach maximum observed serum concentration.
Measure:Area Under the Serum Concentration-time Curve From t1 to t2 Time (AUC[t1-t2]) of JNJ-70218902
Time Frame:Up to 2.5 years
Safety Issue:
Description:AUC(t1-t2) is defined as the area under the serum concentration-time curve from time t1 to t2.
Measure:Area Under the Concentration-time Curve From Time Zero to End of Dosing Interval (AUCtau) of JNJ-70218902
Time Frame:Up to 2.5 years
Safety Issue:
Description:AUCtau is the measure of the serum drug concentration from time zero to end of dosing interval.
Measure:Minimum Observed Serum Concentration (Cmin) of JNJ-70218902
Time Frame:Up to 2.5 years
Safety Issue:
Description:Cmin is the minimum observed serum concentration of JNJ-70218902.
Measure:Accumulation Ratio (RA) of JNJ-70218902
Time Frame:Up to 2.5 years
Safety Issue:
Description:Accumulation Ratio (RA) is calculated as area under the plasma concentration-time curve from time zero to 24 hours (AUC [0-24]) value at steady state divided by AUC (0-24) value after first dose.
Measure:Systemic Cytokine Concentrations
Time Frame:Up to 2.5 years
Safety Issue:
Description:Cytokines concentration will be measured for biomarker assessment.
Measure:Serum Prostate Specific Antigen (PSA) Concentration
Time Frame:Up to 2.5 years
Safety Issue:
Description:Serum prostate specific antigen (PSA) concentration will be measured.
Measure:Number of Participants With Anti-JNJ-70218902 Antibodies
Time Frame:Up to 2.5 years
Safety Issue:
Description:Number of participants with anti-JNJ-70218902 antibodies will be assessed.
Measure:Objective Response Rate (ORR)
Time Frame:Up to 2.5 years
Safety Issue:
Description:ORR is defined as the percentage of participants who have a Partial Response (PR) or better according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 without evidence of bone progression according to Prostate Cancer Working Group 3 (PCWG3).
Measure:Duration of Response (DOR)
Time Frame:Up to 2.5 years
Safety Issue:
Description:Duration of response (DOR) will be calculated from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the PCWG3 or RECIST version 1.1 response criteria, or death due to any cause, whichever occurs first.

Details

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

Trial Keywords

  • metastatic Castration-Resistant Prostate Cancer (mCRPC)
  • Prostate Cancer

Last Updated

December 30, 2020