RECRUITING

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

Talk to us

Conditions

Prostatic Neoplasms

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 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.

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

Quick Facts

Study Start:2025-07-07
Study Completion:2027-09-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07082920

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * Must have metastatic castration-resistant prostate cancer (mCRPC)
  3. * PSA must measure at least 2 nanograms per milliliters (ng/mL) at screening
  4. * Measurable or evaluable disease
  5. * 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
  6. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  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)
  2. * Known allergies, hypersensitivity, or intolerance to any of the components (e.g., excipients) of JNJ-78278343 or JNJ-95298177
  3. * 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
  4. * 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:
  5. 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
  6. 2. Immune checkpoint inhibitors within 6 weeks prior to the first dose of study treatment
  7. 3. Radium (Ra) 223 dichloride within 28 days prior to the first dose of study treatment
  8. 4. Any prior treatment with kallikrein-related peptidase 2 (KLK2)-targeted therapy
  9. 5. Any prior prostate-specific membrane antigen (PSMA)-targeting therapy (that is \[i.e.\], participants who received PSMA-targeting radioconjugates are excluded) \[Parts 2A and 2B only. Prior 177-Lu-PSMA radionuclide therapy is allowed in Part 1 and required for Part 2C\] but last dose must be \>6 weeks prior to the first dose of study treatment
  10. 6. Any prior antibody drug conjugates (ADCs) with microtubule inhibitor payloads (e.g., auristatins, maytansinoids, tubulysins)
  11. * 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

Contacts and Locations

Study Contact

Study Contact
CONTACT
844-434-4210
Participate-In-This-Study1@its.jnj.com

Principal Investigator

Janssen Research & Development, LLC Clinical trial
STUDY_DIRECTOR
Janssen Research & Development, LLC

Study Locations (Sites)

Florida Cancer Specialists
Sarasota, Florida, 34232
United States

Collaborators and Investigators

Sponsor: Janssen Research & Development, LLC

  • Janssen Research & Development, LLC Clinical trial, STUDY_DIRECTOR, Janssen Research & Development, LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-07
Study Completion Date2027-09-15

Study Record Updates

Study Start Date2025-07-07
Study Completion Date2027-09-15

Terms related to this study

Additional Relevant MeSH Terms

  • Prostatic Neoplasms