Prostate cancer Cancer
Conditions
Interventions
The study will be conducted in 2 Parts:
Part 1: Dose Finding, Participants will receive pasritamig in combination with JNJ-86974680 to determine the recommended phase 2 combination dose (RP2CD) regim
how well participants can take care of themselves) performance status, clinical laboratory tests and electrocardiogram (ECG
test to record heart activity).
All side effects will be recorded until the study ends (around 1 year and 2 months).
Sponsors
Janssen-Cilag International NV
Eligibility
Sex/Gender
Male
Age
18 Years to 110 Years
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed adenocarcinoma of the prostate. Primary small cell carcinoma, carcinoid tumor, neuroendocrine (NE) carcinoma, or large cell NE carcinoma arising in the prostate are not allowed; however, adenocarcinomas with NE features (for example [e.g.], immunohistochemistry [IHC] with both androgen receptor [AR]- and NEmarker positivity) are allowed. 2. Metastatic castration-resistant prostate cancer (mCRPC) that is metastatic either to bone, any lymph node, or both without clear evidence of metastasis to visceral organs. Local-regional invasion (rectum, bladder) and bone disease with soft tissue component can be included 3. Prior orchiectomy or medical castration (for example, 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) 4. Prostate-specific antigen (PSA) greater than or equal to (>=) 2 nanograms per milliliters (ng/mL) at screening 5. Measurable or evaluable disease 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion criteria
Exclusion criteria: 1. Toxicity related to prior anticancer therapy that has not returned to grade less than or equal to (2 weeks, and who are off corticosteroid treatment for at least 2 weeks prior to first dose of study treatment 5. Any serious underlying medical conditions or other issue that would impair the ability of the participant to receive or tolerate the planned treatment at the investigational site to understand the informed consent, or any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. 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. 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. Cytokine release syndrome (CRS) and immune effector cell associated neurotoxicity syndrome (ICANS) will be graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) guidelines and ocular events will be graded using the alternative scale provided in the protocol. [Time Frame: Up to 1 year 2 months] 2. Part 1: Number of Participants With Dose-Limiting Toxicity (DLT) High grade hematologic or non-hematologic toxicities with exceptions and/or toxicities leading to treatment discontinuation will be regarded as DLT. [Time Frame: Up To Day 22] | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Objective Response Rate (ORR). ORR is defined as the percentage of participants who have a partial response (PR) or better according to the response evaluation criteria in solid tumors (RECIST) version 1.1 response criteria without evidence of bone progression according to prostate cancer working group 3 (PCWG3). [Time Frame: Up to 1 year 2 months] 2. Prostate-Specific Antigen (PSA) Response Rate PSA response rate is defined as the percentage of participants with a decline of PSA of 50% or more from baseline. [Time Frame: Up to 1 year 2 months] 3. Duration of Response (DOR) DOR will be calculated among responders (PR or better) 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. [Time Frame: Up to 1 year 2 months] 4. Radiographic Progression-Free Survival (rPFS) rPFS is defined as the time from the date of first dose of pasritamig or JNJ-86974680 until the date of radiographic disease progression or death, whichever comes first. [Time Frame: Up to 1 year 2 months] 5. Time to Response (TTR) TTR is defined for the responders as the time from the date of first dose of any study treatment to the date of first documented response. [Time Frame: Up to 1 year 2 months] 6. Serum Concentration of Pasritamig Serum samples will be analysed to determine concentrations of pasritamig. [Time Frame: Up to 1 year 2 months] 7. Plasma Concentration of JNJ-86974680 Plasma samples will be analysed to determine concentrations of JNJ-86974680. [Time Frame: Up to 1 year 2 months] 8. Number of Participants With Anti-Pasritamig Antibodies Serum samples will be analysed for the detection of anti-pasritamig antibodies using a validated assay method. Up to 1 year and 2 months | — |
Countries
England, United Kingdom, United States of America
Contacts
Public ContactLarissa Bates
Outcome results
None listed