Recruiting NCT07319871
A Study of Pasritamig (JNJ-78278343) in Combination With JNJ-86974680 for Treatment of Prostate Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pasritamig, JNJ-86974680.
- Who it may be relevant to
- Registry conditions: Prostatic Neoplasms. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Phase 1b Study of Pasritamig (JNJ-78278343), a T-cell Redirecting Agent Targeting Human Kallikrein 2 (KLK2), in Combination With JNJ-86974680, an A2a Receptor (A2aR) Antagonist, for Prostate Cancer
Overview
The purpose of this study is to identify the recommended phase 2 combination dose (RP2CD) of Pasritamig in combination with JNJ-86974680 in Part 1 (Dose finding) of the study and to determine how safe and tolerable the RP2CD is for treatment of participants with advanced prostate cancer in Part 2 (Dose expansion) of study.
Interventions
- Drug Pasritamig
Pasritamig will be administered intravenously. - Drug JNJ-86974680
JNJ-86974680 will be administered orally.
Primary outcome measures
- Number of Participants With Adverse Events (AEs) by Severity [Time frame: Up to 1 year 2 months]
- Part 1: Number of Participants With Dose-Limiting Toxicity (DLT) [Time frame: Up To Day 22]
Secondary outcome measures (8)
- Objective Response Rate (ORR) [Time frame: Up to 1 year 2 months]
- Prostate-Specific Antigen (PSA) Response Rate [Time frame: Up to 1 year 2 months]
- Duration of Response (DOR) [Time frame: Up to 1 year 2 months]
- Radiographic Progression-Free Survival (rPFS) [Time frame: Up to 1 year 2 months]
- Time to Response (TTR) [Time frame: Up to 1 year 2 months]
- Serum Concentration of Pasritamig [Time frame: Up to 1 year 2 months]
- Plasma Concentration of JNJ-86974680 [Time frame: Up to 1 year 2 months]
- Number of Participants With Anti-Pasritamig Antibodies [Time frame: Up to 1 year 2 months]
Eligibility criteria
Inclusion criteria
- 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 NE-marker positivity) are allowed
- 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
- 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)
- Prostate-specific antigen (PSA) greater than or equal to (>=) 2 nanograms per milliliters (ng/mL) at screening
- Measurable or evaluable disease
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion criteria
- Toxicity related to prior anticancer therapy that has not returned to grade less than or equal to (<=) 1 or baseline levels (except for alopecia, neuropathy \[Grade 2\] and vitiligo)
- Known allergies, hypersensitivity, or intolerance to any of the components (for example, excipients) of pasritamig or JNJ-86974680
- Active infection or condition that requires treatment with systemic antibiotics within 7 days prior to the first dose of study treatment. Antibiotic or antiviral prophylaxis is allowed
- Have leptomeningeal disease or brain metastases, except participants with definitively, locally treated brain metastases that are clinically stable and asymptomatic >2 weeks, and who are off corticosteroid treatment for at least 2 weeks prior to first dose of study treatment
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 3 centers
- Florida Cancer Specialists — Sarasota
- Columbia University Medical Center — New York
- University Hospitals Cleveland Medical Center — Cleveland
United Kingdom · 2 centers
- The Christie NHS Foundation Trust Christie Hospital — Manchester
- Royal Marsden Hospital — Sutton
Identifiers
NCT: NCT07319871 · 78278343PBPCR1005 · 78278343PBPCR1005