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RecruitingPhase 1

A Study of Pasritamig (JNJ-78278343) in Combination With Other Agents for Metastatic Prostate Cancer

A Phase 1b Study of JNJ-78278343, Targeting Human Kallikrein 2 (KLK2) in Combination With Other Agents for Metastatic 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 pasritamig with other medicines for prostate cancer that has spread to other parts of the body. It aims to find doses and treatment schedules for further study and check their safety. Most study groups are for people whose cancer keeps growing despite treatment to lower testosterone; one group is for cancer that still responds to hormone treatment.

The purpose of this study is to identify the recommended phase 2 regimen(s) RP2R(s) of pasritamig and combination regimens in Part 1 (dose escalation) and to determine safety at the putative RP2R(s) of pasritamig with the combination regimens in Part 2 (dose expansion).

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

Eligibility

Who can join

  • Most groups require confirmed prostate adenocarcinoma, a type of prostate cancer, that has spread and keeps growing despite treatment to lower testosterone.
  • Some groups also require a PSA level of at least 2 ng/mL. PSA is a substance measured in blood to help track prostate cancer.
  • Part 2H requires cancer that has spread but still responds to hormone treatment, PSA above 0.2 ng/mL, and 6 to 24 months of treatment with a newer hormone-blocking medicine.
  • Your cancer must be able to be measured or checked, except in Part 2H.
  • Most groups require past treatment with a hormone-blocking medicine. The cetrelimab group allows past hormone-blocking treatment or chemotherapy. Cabazitaxel groups require both a hormone-blocking medicine and docetaxel chemotherapy.
  • In Part 2H, you may have had up to 6 rounds of docetaxel, with the last dose at least 2 months before joining.
  • Lutetium Lu-177 groups require past hormone-blocking treatment, but no past cell-killing chemotherapy or targeted radiation medicine for cancer that resists testosterone-lowering treatment.
  • You must be fully active or able to do light work despite some limits on hard physical activity. Your organs must work well enough.

Who can't join

  • An autoimmune disease active within the past 12 months that needs medicine to weaken the immune system throughout the body. Autoimmune disease means the immune system attacks healthy tissue.
  • Side effects from past cancer treatment that have not become mild or returned to your usual level. Exceptions include hair loss, loss of skin color, and mild or moderate nerve damage.
  • A past organ or bone marrow transplant.
  • Known allergies to, or inability to tolerate, any ingredients in the study medicines for your group.
  • Major infections or serious lung, heart, or other health problems.

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

Official eligibility criteria

Inclusion Criteria: * Part 1 A-G, 1I, 1J, and 1K (all combination treatments) and Parts 2B-C (cabazitaxel, docetaxel): Metastatic castration-resistant prostate cancer (mCRPC) with confirmed adenocarcinoma of the prostate as defined by prostate cancer working group 3 (PCWG3); Parts 2D-G, 2I, 2J, and 2K (apalutamide, enzalutamide, darolutamide, abiraterone acetate + prednisone \[AAP\], lutetium Lu-177 vipivotide tetraxetan, JNJ-101556143): mCRPC: Histologically confirmed adenocarcinoma of the prostate as defined by PCWG3, with a minimum PSA of 2 nanogram \[ng\]/milliliter (mL); Part 2H (apalutamide): metastatic hormone-sensitive prostate cancer(mHSPC) with PSA greater than (\>) 0.2 ng/mL on 6 to 24 months of treatment with a next generation ARPI (apalutamide, enzalutamide, darolutamide, or abiraterone) * Measurable or evaluable disease, except for Part 2H * (a) Part 1A (cetrelimab) - Prior treatment for mCRPC with at least 1 prior androgen receptor pathway inhibitors (ARPI) (that is, abiraterone acetate, apalutamide, enzalutamide, darolutamide), or chemotherapy (example, docetaxel). (b) Part 1C and 2C (docetaxel), Part 1D (apalutamide), Part 1E and 2E (enzalutamide), Part 1F and 2F (darolutamide), and Part 1G, 2G (AAP), and Part 1K \& 2K (JNJ-101556143)- Prior treatment with at least 1 prior ARPI (that is, apalutamide, enzalutamide, darolutamide, or abiraterone acetate). (C) Part 1B and 2B (cabazitaxel) - Prior treatment with at least 1 prior ARPI (ie, abiraterone acetate, apalutamide, enzalutamide, darolutamide) and docetaxel. (d) Part 2D (apalutamide) - Prior treatment with at least 1 prior ARPI (e) Part 2H (apalutamide)- Participant may have received up to 6 cycles of docetaxel. The last dose of docetaxel must be administered at least 2 months prior to enrollment (f) Parts 1I, 1J, 2I \& 2J (lutetium Lu-177 vipivotide tetraxetan)- Prior treatment with at least 1 ARPI (abiraterone acetate, enzalutamide, darolutamide, or apalutamide). Participant must not have received prior cytotoxic chemotherapy or prior radioligand therapy (RLT) for mCRPC * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Adequate organ functions Exclusion Criteria: * Active autoimmune disease within the 12 months prior to signing consent that requires systemic immunosuppressive medications * Toxicity related to prior anticancer therapy that has not returned to Grade less than or equal to (\<=) 1 or baseline levels (except for alopecia, vitiligo, Grade \<=2 peripheral neuropathy) * Solid organ or bone marrow transplantation * Known allergies, or intolerance to any of the components (example, excipients) of pasritamig, cetrelimab (Part 1A), cabazitaxel, Part 1B and 2B , docetaxel Part 1C and 2C , apalutamide (Part 1D and 2D and Part 2H), enzalutamide (Part 1E and 2E), darolutamide (Part 1F and 2F), or AAP (Part 1G and 2G), lutetium Lu-177 vipivotide tetraxetan (Parts 1I, 1J, 2I, and 2J), or JNJ-101556143 (Parts 1K \& 2K) * Significant infections or serious lung, heart or other medical conditions

Study sites (7)

FL

MI

MO

NY

PA