A Study of JNJ-101556143 in Participants With Metastatic Prostate Cancer
ConditionProstatic Neoplasms
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorJanssen Research & Development, LLC
About this trial
The purpose of this study is to evaluate how well JNJ-101556143 works in participants with metastatic androgen pathway modulation-resistant prostate cancer (mAPMR), an advanced form of prostate cancer that has spread and no longer responds to hormone therapy. The study will measure the overall response (tumor shrinkage or disappearance) following treatment with JNJ-101556143.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Have histologically confirmed adenocarcinoma of the prostate. Primary (or pathologic evidence of conversion to) small cell carcinoma, carcinoid tumor, mixed neuroendocrine carcinoma, large cell neuroendocrine carcinoma, or sarcoma of the prostate is disallowed
Progressive metastatic androgen pathway modulation-resistant prostate cancer (mAPMR) defined as having a Prostate-Specific Antigen (PSA) level greater than or equal (>=) 10 nanograms per milliliter (ng/mL) and at least one of the following: (a) PSA progression defined as at least 2 consecutive increases in PSA value over a previous reference value measured at least 1 week apart. (b) Progressive disease or new lesion(s) in the lymph nodes, bones, or viscera on conventional imaging (computed tomography [CT]/magnetic resonance imaging [MRI]) as defined by response evaluation criteria in solid tumors version 1.1 (RECIST v1.1) and/or on bone scan per Prostate Cancer Working Group 4 (PCWG4) while on Androgen Deprivation Therapy (ADT) (either surgically [bilateral orchiectomy] or with medication). Local-regional disease including invasive disease of rectum, bladder, pelvis is allowed as long as participant has a current or past history of distant metastasis (M1 disease). Participants in Part 1 must have measurable disease per RECIST v1.1 by conventional imaging with CT or MRI (chest, abdomen, and pelvis) and/or Technetium-99^m (99^mTc) bone scan confirmed by Blinded Independent Central Review (BICR) at the time of screening
Prior bilateral orchiectomy or medical castration (receiving ongoing ADT with a Gonadotropin-Releasing Hormone (GnRH) analog [agonist or antagonist]) with castrate level of serum testosterone (less than [<] 50 nanograms per deciliter [ng/dL] or 1.7 nanomoles per liter [nmol/L]) prior to the first dose of trial intervention and must continue this therapy throughout the treatment phase
Have discontinued concurrent use of any non-investigational systemic anticancer therapy (that is, cytotoxic chemotherapy, Androgen Receptor Pathway Inhibitor (ARPI), radiation therapy) within 2 weeks or Lutetium-177 Prostate-Specific Membrane Antigen-617 (177^Lu PSMA-617) within 6 weeks prior to first dose of trial intervention, or any investigational drugs within 3 months of first dose of trial intervention
Disqualifiers
Acute or chronic uncontrolled renal disease, pancreatitis, or liver disease (with exception of patients with Gilbert's Syndrome, asymptomatic gallstones, liver metastases, or stable chronic liver disease per investigator assessment)
Suspected or known allergies, hypersensitivity, or intolerance to JNJ-101556143 or its excipients
Had major surgery or had significant traumatic injury less than or equal to 28 days of the first dose of trial intervention. Note: Participants with planned surgical procedures to be conducted under local anesthesia may participate
Spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days
Trial design
Design model
Single group
Treatments tested in this trial
JNJ-101556143
DrugParticipants will receive JNJ-101556143 orally.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: JNJ-101556143Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Overall Response Rate (ORR)
Confirmed overall response, is defined as having either confirmed complete response (CR) or partial response (PR) per response evaluation criteria in solid tumors version 1.1 (RECIST v1.1) by blinded independent central review (BICR) prior to any subsequent anti-cancer therapy.
Time frame
Up to 2 years and 8 monthsSecondary outcomes
1
Duration of Response (DoR)
DoR is defined as the time from the date of first documented response for a confirmed radiographic response (CR or PR) per RECIST v1.1 until the date of documented radiographic progression by BICR, or death, whichever comes first.
Time frame
Up to 2 years and 8 months2
Radiographic Progression-Free Survival (rPFS)
rPFS is defined as the time from the date of initiation of therapy until the date of radiographic disease progression or death, whichever comes first.
Time frame
Up to 2 years and 8 months3
Time to Symptomatic Progression (TSP)
TSP is defined as the time from the first dose of trial intervention until the date of symptomatic progression or death, whichever comes first.
Time frame
Up to 2 years and 8 months4
Number of Participants with Treatment-Emergent Adverse Event (TEAE) by Severity
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE). Severity scale defined as 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 2 years and 8 monthsSponsors and contacts
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Source ClinicalTrials.gov