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RecruitingPhase 1

A Study of JNJ-78278343 in Combination With JNJ-95298177 for Treatment of Prostate Cancer

A Phase 1b Study of JNJ-78278343, a T-cell Redirecting Agent Targeting Human Kallikrein 2 (KLK2), in Combination With JNJ-95298177, an Antibody Drug Conjugate Targeting Prostate Specific Membrane Antigen, 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
Male only
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 JNJ-78278343 with JNJ-95298177 for prostate cancer that has spread and no longer responds to hormone treatment. It aims to find a dose for further testing and check its safety, with or without a third drug, JNJ-87189401.

The purpose of this study is to identify the recommended phase 2 combination dose (RP2CD) of JNJ-78278343 in combination with JNJ-95298177 in Part 1 (Dose confirmation) of the study and to determine how safe and tolerable the RP2CD of JNJ-7827834 and JNJ-95298177 with or without JNJ-87189401 is for treatment of participants with metastatic castration-resistant prostate cancer (mCRPC; a stage of prostate cancer where the cancer has spread beyond the prostate and is resistant to hormonal therapy) 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 nerve-like cell features is allowed.
  • Have prostate cancer that has spread and no longer responds to hormone treatment.
  • Have a PSA blood test result of at least 2 ng/mL at screening.
  • Have cancer that can be measured or checked in other ways.
  • Have had surgery to remove the testicles or treatment to lower testosterone. If you have not had this surgery, you must take a GnRH hormone-blocking drug before and throughout study treatment.
  • Be fully active or able to do light work despite limits on hard physical activity.

Who can't join

  • Still have side effects from past cancer treatment that are more than mild and have not returned to your usual level. Hair loss and vitiligo (loss of skin color) are allowed.
  • Have a known allergy or cannot tolerate any ingredient in the three study drugs.
  • 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 steroid treatment for at least 2 weeks before study treatment.
  • Have taken cancer treatment or an experimental drug within 14 days before study treatment. Longer waits apply to treatments that redirect immune T cells (90 days), immune checkpoint drugs (6 weeks), and radium-223 (28 days).
  • Have ever had treatment aimed at KLK2, a protein target.
  • Have ever had treatment aimed at PSMA, a protein target, if joining Part 2A or 2B. Past PSMA-targeted radiation drug treatment is allowed in Part 1 and required in Parts 2C and 2D, but the last dose must be more than 3 months before study treatment.
  • Have ever had an antibody-linked drug carrying a microtubule inhibitor, a drug that blocks structures cells need to divide.
  • Have a serious health problem or other issue that could make treatment unsafe, prevent you from understanding consent, or affect study checks. The study doctor may also decide joining is not 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 * Must have metastatic castration-resistant prostate cancer (mCRPC) * PSA must measure at least 2 nanograms per milliliters (ng/mL) at screening * Measurable or evaluable disease * Prior orchiectomy or medical castration; or, for participants who have not undergone orchiectomy, 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 * 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 and vitiligo) * Known allergies, hypersensitivity, or intolerance to any of the components (e.g., excipients) of JNJ-78278343, JNJ-95298177, or JNJ-87189401 * Participants with leptomeningeal disease or brain metastases, with the exception of participants with definitively, locally treated brain metastases that are clinically stable and asymptomatic greater than (\>) 2 weeks, and who are off corticosteroid treatment for at least 2 weeks prior to first dose of study treatment * Treatment with any anti-cancer or investigational agents within 14 days prior to the first dose of study treatment; specific requirements for certain anti-cancer therapies are as follows: 1. Any T-cell redirecting treatment (e.g., CD3-directed bispecific or Chimeric Antigen Receptor T-cell \[CAR-T\] therapy) within 90 days prior to the first dose of study treatment 2. Immune checkpoint inhibitors within 6 weeks prior to the first dose of study treatment 3. Radium (Ra) 223 dichloride within 28 days prior to the first dose of study treatment 4. Any prior treatment with kallikrein-related peptidase 2 (KLK2)-targeted therapy 5. Any prior prostate-specific membrane antigen (PSMA)-targeting therapy (that is \[i.e.\], participants who received PSMA-targeting radioconjugates are excluded) \[Parts 2A and 2B only\]. Prior PSMA RLT is allowed in Part 1 and required for Part 2C and Part 2D but last dose must be \>3 months prior to the first dose of study treatment 6. Any prior antibody drug conjugates (ADCs) with microtubule inhibitor payloads (e.g., auristatins, maytansinoids, tubulysins) * 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 (4)

FL

NY

OH

WA