A Study of JNJ-98768111 in Participants With 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 Part 1 of this study is to find out how safe JNJ-98768111 is and the most suitable dose (recommended phase 2 dose \[RP2D\]) regimen(s) of JNJ-98768111. The purpose of Part 2 of this study is to find out how safe JNJ-98768111 is at the RP2D regimen(s) in participants with advanced prostate cancer (cancer of the prostate, a male reproductive gland found below the bladder, which has spread extensively to other parts of the body).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
a. Histologically confirmed adenocarcinoma of the prostate. Adenocarcinoma with small cell or neuroendocrine features is permitted. b. Measurable or evaluable disease (metastatic prostate cancer) based on computed tomography (CT), magnetic resonance imaging (MRI), or bone scan. Prior treatment with at least 1 prior novel androgen receptor (AR)-targeted therapy. c. Serum prostate-specific antigen (PSA) value greater than or equal to (>=) 2 nanograms per milliliters (ng/mL). d. Prior orchiectomy or medical castration; or, for participants who have not undergone orchiectomy, must be receiving ongoing androgen deprivation therapy (ADT) with a gonadotropin releasing hormone (GnRH) analog (agonist or antagonist) prior to the first dose of trial drug and must continue this therapy throughout the treatment phase; e. Castrate levels of serum testosterone as defined in the protocol, prior to the first dose of trial intervention; f. Progressive metastatic disease following their most recent line of therapy. Disease progression will be defined by at least one of the following: PSA progression, radiographic progression according to response evaluation criteria in solid tumors (RECIST v1.1), or progressive bone disease according to prostate cancer working group 3 (PCWG3) criteria
Eastern cooperative oncology group (ECOG) performance status of 0 or 1
Agree to all of the following during the trial and for 6 months after the last dose of trial drug: a. Use a highly effective method of contraception; b. Wear a condom when engaging in any activity that allows for passage of ejaculate to another person; c. Not to donate sperm or freeze for future use for the purpose of reproduction; d. Not plan to father a child. In addition, the participant should be advised of the benefit for a female partner to use a highly effective method of contraception
Sign an informed consent form (ICF) indicating that the participant understands the purpose of, and procedures required for, the trial and is willing to participate in the trial
Disqualifiers
Active central nervous system (CNS) involvement
Toxicity related to prior anticancer therapy that has not returned to Grade less than or equal to (<=) 1 or baseline levels
External beam radiation therapy to soft tissue lesions within 14 days prior to start of trial intervention
History of clinically significant cardiovascular disease within 6 months prior to signing informed consent
Trial design
Design model
Sequential
Treatments tested in this trial
JNJ-98768111
DrugJNJ-98768111 will be administered intravenously.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: JNJ-98768111Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants with Adverse Events (AEs)
An AE is any untoward medical occurrence in a clinical trial participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the treatment.
Time frame
Up to approximately 2 years 7 months2
Part 1: Number of Participants with Dose-Limiting Toxicities (DLT)
High grade hematologic or non-hematologic toxicities with exceptions and/or toxicities leading to treatment discontinuation will be regarded as DLT. Other DLT criteria includes any related toxicity resulting in permanent treatment discontinuation or a delay in dose administration greater than (\>)14 days and any death not clearly due to the underlying disease or non-trial intervention-related causes.
Time frame
From first administration of trial intervention to the pre-dose assessment of the second cycle (up to approximately 2 years and 7 months)Secondary outcomes
1
Maximum Observed Concentration (Cmax) of JNJ-98768111
Cmax of JNJ-98768111 will be reported.
Time frame
Up to approximately 2 years 7 months2
Trough Concentration (Ctrough) of JNJ-98768111
Ctrough of JNJ-98768111 will be reported.
Time frame
Up to approximately 2 years 7 months3
Time to Maximum Observed Concentration (Tmax) of JNJ-98768111
Tmax of JNJ-98768111 will be reported.
Time frame
Up to approximately 2 years 7 months4
Area Under the Concentration-Time Curve from Time 0 to End of Dosing Interval (AUC [0-tau]) of JNJ-98768111
AUC0-tau of JNJ-98768111 will be reported.
Time frame
Up to approximately 2 years 7 monthsSponsors and contacts
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Source ClinicalTrials.gov