Pasritamig plus JNJ-86974680 for advanced prostate cancer
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
This trial will test whether combining pasritamig with JNJ-86974680 is safe and to find the best dose for people with metastatic castration-resistant prostate cancer.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Janssen Research & Development, LLC Industry-sponsored |
| Locations | 5 sites (Sarasota, Florida and 4 other locations) |
| Trial ID | NCT07319871 on ClinicalTrials.gov |
What this trial studies
This is a Phase 1, two-part dose-finding and dose-expansion trial of pasritamig combined with JNJ-86974680 in participants with advanced prostate adenocarcinoma. Part 1 uses escalating doses to identify a recommended Phase 2 combination dose (RP2CD), and Part 2 gives that dose to more participants to characterize safety and tolerability. Eligible participants must have metastatic castration-resistant prostate cancer and remain on androgen deprivation therapy during treatment. The trial is being conducted at multiple U.S. cancer centers and is sponsored by Janssen Research & Development.
Who should consider this trial
Good fit: Men with histologically confirmed metastatic castration-resistant prostate adenocarcinoma who are on continuous androgen deprivation therapy and meet other health criteria are the intended candidates.
Not a fit: Patients with primary neuroendocrine prostate cancers, significant visceral metastases, or who are not on required androgen deprivation therapy are unlikely to qualify or benefit from this trial.
Why it matters
Potential benefit: If successful, the combination could offer a new treatment option that better controls disease or delays progression in some men with advanced prostate cancer.
How similar studies have performed: This specific combination is early-phase and relatively novel, and while other targeted drug combinations have shown promise in early trials, there is limited prior data on these two agents together.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Sarasota, Florida and 4 other locations
- Florida Cancer Specialists — Sarasota, Florida, United States (Recruiting)
- Columbia University Medical Center — New York, New York, United States (Recruiting)
- University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States (Recruiting)
- The Christie NHS Foundation Trust Christie Hospital — Manchester, United Kingdom (Recruiting)
- Royal Marsden Hospital — Sutton, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Study Contact
- Email: Participate-In-This-Study1@its.jnj.com
- Phone: 844-434-4210
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.