A Study of JNJ-78278343 in Combination With JNJ-95298177 for Treatment of Prostate Cancer
NCT ID: NCT07082920
Last Updated: 2026-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
140 participants
INTERVENTIONAL
2025-07-07
2027-09-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part 1: Dose Confirmation
Participants will receive JNJ-78278343 in combination with JNJ-95298177 in a dose de-escalation schedule in accordance with the Bayesian Optimal Interval Design (BOIN) design to determine the recommended phase 2 combination dose (RP2CD) regimen.
JNJ-78278343
JNJ-78278343 will be administered intravenously.
JNJ-95298177
JNJ-95298177 will be administered intravenously.
Part 2: Dose Expansion
Participants will receive JNJ-78278343 in combination with JNJ-95298177 at the RP2CD as determined in Part 1 of the study to confirm the safety and anti-tumor activity.
JNJ-78278343
JNJ-78278343 will be administered intravenously.
JNJ-95298177
JNJ-95298177 will be administered intravenously.
Interventions
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JNJ-78278343
JNJ-78278343 will be administered intravenously.
JNJ-95298177
JNJ-95298177 will be administered intravenously.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Known allergies, hypersensitivity, or intolerance to any of the components (e.g., excipients) of JNJ-78278343 or JNJ-95298177
* 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
18 Years
MALE
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Florida Cancer Specialists
Sarasota, Florida, United States
Columbia University Medical Center
New York, New York, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
The Christie Nhs Foundation Trust
Manchester, , United Kingdom
Royal Marsden Hospital (Sutton)
Sutton, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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78278343PBPCR1004
Identifier Type: -
Identifier Source: org_study_id
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