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RecruitingPhase 1

A Study of Pasritamig (JNJ-78278343) in Combination With JNJ-86974680 for Treatment of 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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests pasritamig with JNJ-86974680 for people with advanced prostate cancer. The first part looks for the dose to use together. The second part checks how safe that dose is and how well people can tolerate it.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have prostate adenocarcinoma, a cancer of gland cells, confirmed by a tissue test. Certain other prostate cancer types are not allowed, but adenocarcinoma with some neuroendocrine features is allowed.
  • Have prostate cancer that grows despite treatment to lower testosterone. It must have spread to bones, lymph nodes, or both, with no clear spread to internal organs. Growth into the nearby bladder or rectum, or from bone into soft tissue, is allowed.
  • Have had surgery to remove the testicles, or be taking medicine to lower testosterone before study treatment and throughout treatment.
  • Have a PSA blood test level of at least 2 ng/mL at screening. PSA is a protein made by prostate cells.
  • Have cancer that can be measured or checked.
  • Be fully active or able to do light work, even if hard physical activity is limited.

Who can't join

  • Still have side effects from earlier cancer treatment that are more than mild and have not returned to your usual level. Exceptions include hair loss, moderate nerve damage, and vitiligo, which causes patches of skin to lose color.
  • Have a known allergy or cannot tolerate any ingredient in either study drug.
  • Have an active infection or condition needing antibiotics that treat the whole body within 7 days before the first study dose. Antibiotics or antiviral drugs used to prevent infection are allowed.
  • Have cancer in the tissue around the brain or spinal cord, or cancer that has spread to the brain. Treated brain cancer may be allowed if it is stable and causes no symptoms for more than 2 weeks, and you have been off steroids for at least 2 weeks before treatment.
  • Have a serious health condition or other issue that could make treatment unsafe, make it hard to understand consent, or interfere with study tests. The study doctor may also exclude you if joining would not be in your best interest.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (3)

FL

NY

OH