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OncoMatch/Clinical Trials/NCT07082920

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

Is NCT07082920 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies multiple treatments including JNJ-78278343 and JNJ-95298177 for prostatic neoplasms.

Phase 1RecruitingJanssen Research & Development, LLCNCT07082920Data as of Jun 2026Location: United States · United Kingdom

Treatment: JNJ-78278343 · JNJ-95298177The 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 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.

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Extracted eligibility criteria

Treatments studied

Other

JNJ-78278343JNJ-95298177

Cancer type

Prostate Cancer

Disease stage

Metastatic disease required

Performance status

ECOG 0–1(Restricted strenuous activity)

Demographics

Male only

Prior therapy

Must have received: androgen deprivation therapy (orchiectomy, gonadotropin-releasing hormone (GnRH) analog (agonist or antagonist)) — castration

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

Cannot have received: T-cell redirecting treatment (CD3-directed bispecific, Chimeric Antigen Receptor T-cell (CAR-T) therapy)

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

Cannot have received: immune checkpoint inhibitor

Immune checkpoint inhibitors within 6 weeks prior to the first dose of study treatment

Cannot have received: radium-223 dichloride (radium (Ra) 223 dichloride)

Radium (Ra) 223 dichloride within 28 days prior to the first dose of study treatment

Cannot have received: KLK2-targeted therapy

Any prior treatment with kallikrein-related peptidase 2 (KLK2)-targeted therapy

Cannot have received: PSMA-targeting therapy

Exception: 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

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

Cannot have received: antibody-drug conjugate (auristatins, maytansinoids, tubulysins)

Any prior antibody drug conjugates (ADCs) with microtubule inhibitor payloads (e.g., auristatins, maytansinoids, tubulysins)

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Florida Cancer Specialists · Sarasota, Florida
  • Columbia University Medical Center · New York, New York
  • University Hospitals Cleveland Medical Center · Cleveland, Ohio
  • Fred Hutchinson Cancer Center · Seattle, Washington

Showing up to 5 US sites.

See all sites on ClinicalTrials.gov →

Frequently asked questions

Is NCT07082920 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior T-cell redirecting treatment, immune checkpoint inhibitor, radium-223 dichloride disqualifies patients from enrollment.

Is this trial open to female patients?

No. This trial enrolls male patients only.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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