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A Study of JNJ-87189401 Combined With JNJ-78278343 for Advanced Prostate Cancer

ConditionProstatic Neoplasms
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18+
SponsorJanssen Research & Development, LLC

About this trial

The purpose of Parts 1, 2A, and 2B of the study is to determine the recommended regimen for Phase 2 (RP2Rs) of combination of JNJ-87189401 with JNJ-78278343 and the purpose of Part 2C of this study is to determine how safe the RP2R(s) of the combination of JNJ-87189401 and JNJ-78278343 is, with or without apalutamide. Part 3 of this study evaluates the safety of the triplet combination of JNJ-87189401 and JNJ-78278343 with standard of care (SOC) lutetium Lu-177 vipivotide tetraxetan. Part 4 of this study further evaluates the safety of the triplet combination of JNJ-87189401 and JNJ-78278343 with JNJ-101556143 in participants with advanced prostate cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically confirmed adenocarcinoma of the prostate. Adenocarcinoma with small cell or neuroendocrine (NE) features is permitted. However, small cell carcinoma, carcinoid tumor, mixed NE carcinoma, or large cell NE carcinoma is disallowed

Measurable or evaluable disease per PCWG3 criteria

Part 1, Parts 2A, 2B, 3 and 4: Prior orchiectomy or medical castration; participants who have not undergone orchiectomy, must be receiving ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analog (agonist or antagonist), prior to the first dose of study drug and must continue this therapy throughout the treatment phase

Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Disqualifiers

History of an autoimmune disease within the 12 months prior to signing consent

Any of the following within 6 months prior to signature of informed consent: a. myocardial infarction, b. severe or unstable angina, c. clinically significant ventricular arrhythmias, d. congestive heart failure (New York Heart Association [NYHA] class II to IV), e. transient ischemic attack, and f. Cerebrovascular accident

Trial design

Design model

Sequential

Treatments tested in this trial

  • JNJ-78278343

    Drug

    JNJ-78278343 will be administered.

  • JNJ-87189401

    Drug

    JNJ-87189401 will be administered.

  • Apalutamide

    Drug

    Apalutamide will be administered.

  • Lutetium Lu-177 Vipivotide Tetraxetan

    Drug

    Lutetium Lu-177 Vipivotide Tetraxetan will be administered as SOC treatment.

  • JNJ-101556143

    Drug

    JNJ-101556143 will be administered.

Treatment groups

355 Participants
are divided into 4 treatment groups
Group A: Part 1 (Dose Escalation)Experimental treatment 2 interventions
Group B: Part 2 (Dose Expansion)Experimental treatment 3 interventions
Group C: Part 3Experimental treatment 3 interventions
Group D: Part 4Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Parts 1, 2C, 3 and 4: Number of Participants With Dose Limiting Toxicity (DLT)

DLTs are specific adverse events (AEs) and are defined as any of the following: high grade non-hematologic toxicity or hematologic toxicity.

Time frame
Up to 21 days after first combination dose of study drugs
2

Number of Participants with Adverse Events (AEs) by Severity

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. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 with the exception of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome events, which will be graded by American Society for Transplantation and Cellular Therapy (ASTCT) guidelines. Severity scale ranges from grade 1 (mild) to grade 5 (death). Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening and Grade 5= death related to adverse event.

Time frame
Up to 4 years 8 months

Secondary outcomes

1

Serum Concentrations of JNJ-87189401 and JNJ-78278343

Serum samples will be analyzed to determine concentrations of JNJ-87189401 and JNJ-78278343.

Time frame
Up to 4 years 8 months
2

Plasma Concentration of JNJ-101556143

Plasma samples will be analyzed to determine concentrations of JNJ-101556143.

Time frame
Up to 4 years 8 months
3

Number of Participants With Antibodies to JNJ-87189401 and JNJ-78278343

Number of participants with antibodies to JNJ-87189401 and JNJ-78278343 will be reported.

Time frame
Up to 4 years 8 months
4

Objective Response Rate (ORR)

ORR is defined as the proportion 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 Clinical Trials Working Group 3 (PCWG3).

Time frame
Up to 4 years 8 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Janssen Research & Development, LLC

Lead sponsor

Source ClinicalTrials.gov
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