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

NCT07082920
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Phase
Phase 1
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Recruitment status
Recruiting
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Participants
140
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Lead sponsor
Janssen Research & Development, LLC
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Start date
2025-07-07
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Number of sites
6
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Summary
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.
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Short title
A Study of JNJ-78278343 in Combination With JNJ-95298177 for Treatment of Prostate Cancer
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Official title
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
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2027-12-30
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First posted
2025-07-24
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Registry last updated
2026-09-25
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Primary completion date
2027-11-30
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Start date
2025-07-07
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Participants
140
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Participant count basis
Estimated
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Planned participants
140
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Protocol amendments
2
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Number of sites
6
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Janssen Research & Development, LLC
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07082920
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ClinicalTrials.gov ID
NCT07082920
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Registry record
Open registry record
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Allocation
Not randomised
Model
Sequential
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Number of Participants With Adverse Events (AEs) by Severity

    Timeframe: Up to 2 years 2 months

    An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event. Cytokine release syndrome (CRS) and immune effector cell associated neurotoxicity syndrome (ICANS) will be graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) guidelines and ocular events will be graded using the alternative scale provided in the protocol.

  2. Part 1: Number of Participants With Dose-Limiting Toxicity (DLT)

    Timeframe: Up To Day 22

    High grade hematologic or non-hematologic toxicities with exceptions and/or toxicities leading to treatment discontinuation will be regarded as DLT.

  1. Objective Response Rate (ORR)

    Timeframe: Up to 2 years 2 months

    ORR is defined as the percentage of participants who have a partial response (PR) or better according to the response evaluation criteria in solid tumors (RECIST) version 1.1 response criteria without evidence of bone progression according to prostate cancer working group 3 (PCWG3).

  2. Prostate-Specific Antigen (PSA) Response Rate

    Timeframe: Up to 2 years 2 months

    PSA response rate is defined as the percentage of participants with a decline of PSA of 50% or more from baseline.

  3. Radiographic Progression-Free Survival (rPFS)

    Timeframe: Up to 2 years 2 months

    rPFS is defined as the time from the date of first dose of any study treatment until the date of radiographic disease progression or death, whichever comes first.

  4. Time to Response (TTR)

    Timeframe: Up to 2 years 2 months

    TTR is defined for the responders as the time from the date of first dose of any study treatment to the date of first documented response.

  5. Duration of Response (DOR)

    Timeframe: Up to 2 years 2 months

    DOR will be calculated among responders (PR or better) from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the PCWG3 or RECIST version 1.1 response criteria, or death due to any cause, whichever occurs first.

  6. Serum Concentration of JNJ-78278343

    Timeframe: Up to 2 years 2 months

    Serum samples will be analyzed to determine concentrations of JNJ-78278343.

  7. Serum Concentration of JNJ-95298177

    Timeframe: Up to 2 years 2 months

    Serum samples will be analyzed to determine concentrations of JNJ-95298177 (including ADC, total antibody and payload pAF-AS269).

  8. Serum Concentration of JNJ-87189401

    Timeframe: Up to 2 years 2 months

    Serum samples will be analyzed to determine concentrations of JNJ-87189401.

  9. Number of Participants With Anti-JNJ-78278343 Antibodies

    Timeframe: Up to 2 years 2 months

    Serum samples will be analyzed for the detection of anti-JNJ-78278343 antibodies using a validated assay method.

  10. Number of Participants With Anti-JNJ-95298177 Antibodies

    Timeframe: Up to 2 years 2 months

    Serum samples will be analyzed for the detection of anti-JNJ-95298177 antibodies using a validated assay method.

  11. Number of Participants With Anti-JNJ-87189401 Antibodies

    Timeframe: Up to 2 years 2 months

    Serum samples will be analyzed for the detection of anti-JNJ-87189401 antibodies using a validated assay method.

Sources for outcomes
clinicaltrials.gov

Sex
Male
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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

  • 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

Sources for eligibility
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  • Florida Cancer SpecialistsSarasota, United StatesRecruiting
  • Columbia University Medical CenterNew York, United StatesRecruiting
  • University Hospitals Cleveland Medical CenterCleveland, United StatesRecruiting
  • Fred Hutchinson Cancer CenterSeattle, United StatesRecruiting
  • The Christie Nhs Foundation TrustManchester, United KingdomRecruiting
  • Royal Marsden Hospital (Sutton)Sutton, United KingdomRecruiting
Sources for sites
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)

Targets (1)