Prostate cancer prostate carcinoma
Conditions
Interventions
Participants will receive JNJ-78278343 subcutaneously (SC). The dose levels
will be escalated based on the dose limiting toxicities (DLT) evaluation by the
study evaluation team (SET) in Part 1 (dos
Sponsors
Janssen-Cilag
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Each potential participant must satisfy all of the following criteria to be enrolled in the study: Age 1. 18 years of age or older. Disease Characteristics 2. Confirmed adenocarcinoma of the prostate which has spread to other body parts. 3. Measurable or evaluable disease 4. Prior treatment with at least 1 prior novel androgen receptor (AR)-targeted therapy or chemotherapy. 5. Prior surgical removal of testicles; or, for participants who have not undergone surgical removal of testicles, must be receiving ongoing androgen deprivation therapy (ADT) with a gonadotropin releasing hormone analog. 6. Concurrent use of any other anticancer treatment. 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Exclusion criteria
Exclusion criteria: Any potential participant who meets any of the following criteria will be excluded from participating in the study: Disease Conditions 1. Active central nervous system (CNS) involvement. 2. Toxicity related to prior anticancer therapy has not adequately recovered. Prior/Concomitant Therapy 3. Prior treatment with KLK2-targeted therapy. 4. Received, or are receiving, medications that suppress the immune system within 3 days prior to the first dose of study drug. 5. Received or plans to receive any live, attenuated vaccine within 4 weeks prior to the first dose of study drug. Prior/Concurrent Medical Conditions 6. Diagnosis of cancer other than prostate cancer within 2 years prior to the first dose of study drug. 7. Solid organ or bone marrow transplantation. 8. Major clotting diseases within one month prior to the first dose of study drug. 9. Active autoimmune disease within 12 months prior to the first dose of study drug. 10. Active infection. 11. Major diseases of heart and blood vessels within 6 months prior to the first dose of study drug. 12. Clinically significant lung diseases. 13. Active or chronic hepatitis B or hepatitis C infection. 14. Known positive test result for human immunodeficiency virus (unless stable on antiretroviral therapy with undetectable viral load). 16. Any serious underlying medical conditions or other issue that would impair the ability of the participant to receive or tolerate the planned treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of part 1 is to determine recommended Phase 2 dose(s) (RP2Ds) of JNJ-78278343 by investigating the incidence and severity of AEs, including dose-limiting toxicity. The primary objective of part 2 is to determine the safety at the RP2D(s) by investigating the incidence and severity of AEs | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives are: -Assess the pharmacokinetics by looking at the serum concentration-time profiles and pharmacokinetic parameters for JNJ-78278343 including but not limited to Cmax, Tmax, AUC(t1-t2), AUCtau, Cmin, and accumulation ratio (RA) - Assess the pharmacodynamics by looking at the pharmacodynamic markers including, but not limited to, systemic cytokine concentrations and serum PSA - Assess the immunogenicity by looking at the presence of anti-JNJ-78278343 antibodies -Assess preliminary antitumor activity by looking at the objective response rate, PSA response, and duration of response according to response criteria of the Prostate Cancer Working Group 3 (PCWG3). | — |
Countries
Netherlands
Outcome results
None listed