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Looking for participantsPhase1

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

Sponsor: Janssen Research & Development, LLC

NCT ID: NCT07082920

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
JNJ-78278343 (drug), JNJ-95298177 (drug), JNJ-87189401 (drug)
How long the study runs
Study runs about 29 months (dates as stated)
About the drug or intervention
JNJ-78278343 — drug: JNJ-78278343 will be administered intravenously. · JNJ-95298177 — drug: JNJ-95298177 will be administered intravenously. · JNJ-87189401 — drug: JNJ-87189401 will be administered.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
Male
Number of participants
140
Started
2025-07-07
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for prostatic neoplasms
  • • Phase1 - 140 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with prostatic neoplasms
  • • Male only

Where?

  • • Manchester - The Christie Nhs Foundation Trust
  • • Sutton - Royal Marsden Hospital (Sutton)

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Prostatic Neoplasms

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
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Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: Male only

Biomarkers mentioned

PSACD3

Treatment history

Treatments you must have had:

  • ✓ metastatic castration-resistant prostate cancer (mCRPC)

What the study is looking for

  • ✓Must have that has spread castration-resistant prostate cancer (mCRPC)
  • ✓PSA must measure at least 2 nanograms per milliliters (ng/mL) at screening
  • ✓Measurable or evaluable disease
  • ✓activity scale (ECOG) performance status of 0 or 1

Who cannot take part

  • ✗Toxicity related to prior anticancer therapy that has not returned to grade less than or equal to (\<=) 1 or...
  • ✗Known allergies, hypersensitivity, or intolerance to any of the components (e.g., excipients) of JNJ-78278343,...
  • ✗Treatment with any anti-cancer or investigational agents within 14 days prior to the first dose of study treatment;...
  • ✗Any T-cell redirecting treatment (e.g., CD3-directed bispecific or Chimeric Antigen Receptor T-cell \[CAR-T\]...
  • ✗Immune checkpoint inhibitors within 6 weeks prior to the first dose of study treatment
See the full 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

Where Is This Study? (2 UK sites)

The Christie Nhs Foundation Trust

Manchester M20 4BX, United Kingdom

Recruiting
Hospital R&D contact (matched)

Research and Innovation Office

the-christie.ri@nhs.net---

Royal Marsden Hospital (Sutton)

Sutton SM2 5PT, United Kingdom

Recruiting
Hospital R&D contact (matched)

Mark Brandon-Grove

research.development@rmh.nhs.uk020 3186 5416

How to Get in Touch

Study Contact

Sponsor contact

CONTACT

844-434-4210 Participate-In-This-Study1@its.jnj.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09