A Phase 1 Study of JNJ-78278343, a T Cell Redirecting Agent Targeting Human Kallikrein 2 (KLK2), for Advanced Prostate Cancer

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 25

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective of part 1 is to determine recommended Phase 2 dose(s)<br /><br>(RP2Ds) of JNJ-78278343 by investigating the incidence and severity of AEs,<br /><br>including dose-limiting toxicity.<br /><br>The primary objective of part 2 is to determine the safety at the RP2D(s) by<br /><br>investigating the incidence and severity of AEs</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary objectives are:<br /><br>-Assess the pharmacokinetics by looking at the serum concentration-time<br /><br>profiles and pharmacokinetic parameters for JNJ-78278343 including but not<br /><br>limited to Cmax, Tmax, AUC(t1-t2), AUCtau, Cmin, and accumulation ratio (RA)<br /><br>- Assess the pharmacodynamics by looking at the pharmacodynamic markers<br /><br>including, but not limited to, systemic cytokine concentrations and serum PSA<br /><br>- Assess the immunogenicity by looking at the presence of anti-JNJ-78278343<br /><br>antibodies<br /><br>-Assess preliminary antitumor activity by looking at the objective response<br /><br>rate, PSA response, and duration of response according to response criteria of<br /><br>the Prostate Cancer Working Group 3 (PCWG3).</p><br>