A Phase 1b Study of JNJ-78278343, a T-cell Redirecting Agent Targeting Human Kallikrein 2 (KLK2), in Combination With Either JNJ-63723283 (Cetrelimab), Taxane Chemotherapy, or Androgen Receptor Pathway Inhibitors for Metastatic Prostate Cancer

Status: Recruiting
Location: See all (14) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

The purpose of this study is to identify the recommended phase 2 regimen(s) RP2R(s) of JNJ-78278343 and combination agent in Part 1 (dose escalation) and to determine safety at the putative RP2R(s) of JNJ-78278343 with the combination agent in Part 2 (dose expansion).

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• Part 1 A-G (all combination treatments) and Parts 2B-C (cabazitaxel, docetaxel): Metastatic castration-resistant prostate cancer (mCRPC) with confirmed adenocarcinoma of the prostate as defined by prostate cancer working group 3 (PCWG3); Parts 2D-G (apalutamide, enzalutamide, darolutamide, abiraterone acetate + prednisone \[AAP\]): mCRPC: Histologically confirmed adenocarcinoma of the prostate as defined by PCWG3, with a minimum PSA of 2 nanogram \[ng\]/milliliter (mL); Part 2H (apalutamide): (a) metastatic hormone-sensitive prostate cancer(mHSPC) with PSA greater than (\>) 0.2 ng/mL despite being treated with next generation ARPI (apalutamide, enzalutamide, darolutamide) for between 180 and 365 days (inclusive); (b) Participant may not have progressed radiographically or have PSA progression while receiving androgen deprivation therapy (ADT) and ARPI, as defined by PCWG3

• Measurable or evaluable disease

• (a) Part 1A (cetrelimab) - Prior treatment for mCRPC with at least 1 prior androgen receptor pathway inhibitors (ARPI) (that is, abiraterone acetate, apalutamide, enzalutamide, darolutamide), or chemotherapy (example, docetaxel). (b) Part 1C and 2C (docetaxel), Part 1D (apalutamide), Part 1E and 2E (enzalutamide), Part 1F and 2F (darolutamide), and Part 1G and 2G (AAP)- Prior treatment with at least 1 prior ARPI (that is, apalutamide, enzalutamide, darolutamide, or abiraterone acetate). (C) Part 1B and 2B (cabazitaxel) - Prior treatment with at least 1 prior ARPI (ie, abiraterone acetate, apalutamide, enzalutamide, darolutamide) and docetaxel. (d) Part 2D (apalutamide) - Prior treatment with at least 1 prior ARPI (e) Part 2H (apalutamide)- Participant must not have received prior cytotoxic chemotherapy

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

• Adequate organ functions

Locations
United States
Florida
Florida Cancer Specialists
RECRUITING
Sarasota
Michigan
Start Midwest
RECRUITING
Grand Rapids
Missouri
Washington University School Of Medicine
RECRUITING
St Louis
New York
Perlmutter Cancer Center at NYU Langone Brooklyn
RECRUITING
Brooklyn
Laura & Isaac Perlmutter Cancer Center at NYU Langone Hospital - Long Island
RECRUITING
Mineola
NYU Langone Health
RECRUITING
New York
Pennsylvania
Sidney Kimmel Cancer Center - Jefferson Health
RECRUITING
Philadelphia
Other Locations
Australia
Icon Cancer Centre Kurralta Park
RECRUITING
Kurralta Park
Macquarie University
RECRUITING
Macquarie University
Peter MacCallum Cancer Centre
RECRUITING
Melbourne
Princess Alexandra Hospital
RECRUITING
Woolloongabba
Spain
Hosp Univ Fund Jimenez Diaz
RECRUITING
Madrid
Hosp Univ Hm Sanchinarro
RECRUITING
Madrid
Hosp. Univ. 12 de Octubre
RECRUITING
Madrid
Contact Information
Primary
Study Contact
Participate-In-This-Study1@its.jnj.com
844-434-4210
Time Frame
Start Date: 2023-04-26
Estimated Completion Date: 2027-09-01
Participants
Target number of participants: 185
Treatments
Experimental: JNJ-78278343 + Combination agent: Part 1 (Dose Escalation) and Part 2 (Dose Expansion)
Participants will receive JNJ-78278343 and combination agent (cetrelimab, cabazitaxel, docetaxel, apalutamide, enzalutamide, Darolutamide, abiraterone acetate plus prednisone) during Part 1 (dose escalation). The dose of JNJ-78278343 will be escalated sequentially until a recommended phase 2 regimen (RP2R). Participants will receive JNJ-78278343 and combination agent treatment at the putative RP2R in Part 2 (dose expansion).
Related Therapeutic Areas
Sponsors
Leads: Janssen Research & Development, LLC

This content was sourced from clinicaltrials.gov

Similar Clinical Trials