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A Study of Pasritamig (JNJ-78278343) in Combination With Other Agents for Metastatic Prostate Cancer

NCT05818683 · Janssen Research & Development, LLC
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Official title
A Phase 1b Study of JNJ-78278343, Targeting Human Kallikrein 2 (KLK2) in Combination With Other Agents for Metastatic Prostate Cancer
About this study
The purpose of this study is to identify the recommended phase 2 regimen(s) RP2R(s) of pasritamig and combination regimens in Part 1 (dose escalation) and to determine safety at the putative RP2R(s) of pasritamig with the combination regimens in Part 2 (dose expansion).
Eligibility criteria
Inclusion Criteria: * Part 1 A-G, 1I, 1J, and 1K (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, 2I, 2J, and 2K (apalutamide, enzalutamide, darolutamide, abiraterone acetate + prednisone \[AAP\], lutetium Lu-177 vipivotide tetraxetan, JNJ-101556143): mCRPC: Histologically confirmed adenocarcinoma of the prostate as defined by PCWG3, with a minimum PSA of 2 nanogram \[ng\]/milliliter (mL); Part 2H (apalutamide): metastatic hormone-sensitive prostate cancer(mHSPC) with PSA greater than (\>) 0.2 ng/mL on 6 to 24 months of treatment with a next generation ARPI (apalutamide, enzalutamide, darolutamide, or abiraterone) * Measurable or evaluable disease, except for Part 2H * (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, 2G (AAP), and Part 1K \& 2K (JNJ-101556143)- 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 may have received up to 6 cycles of docetaxel. The last dose of docetaxel must be administered at least 2 months prior to enrollment (f) Parts 1I, 1J, 2I \& 2J (lutetium Lu-177 vipivotide tetraxetan)- Prior treatment with at least 1 ARPI (abiraterone acetate, enzalutamide, darolutamide, or apalutamide). Participant must not have received prior cytotoxic chemotherapy or prior radioligand therapy (RLT) for mCRPC * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Adequate organ functions Exclusion Criteria: * Active autoimmune disease within the 12 months prior to signing consent that requires systemic immunosuppressive medications * Toxicity related to prior anticancer therapy that has not returned to Grade less than or equal to (\<=) 1 or baseline levels (except for alopecia, vitiligo, Grade \<=2 peripheral neuropathy) * Solid organ or bone marrow transplantation * Known allergies, or intolerance to any of the components (example, excipients) of pasritamig, cetrelimab (Part 1A), cabazitaxel, Part 1B and 2B , docetaxel Part 1C and 2C , apalutamide (Part 1D and 2D and Part 2H), enzalutamide (Part 1E and 2E), darolutamide (Part 1F and 2F), or AAP (Part 1G and 2G), lutetium Lu-177 vipivotide tetraxetan (Parts 1I, 1J, 2I, and 2J), or JNJ-101556143 (Parts 1K \& 2K) * Significant infections or serious lung, heart or other medical conditions
Study design
Enrollment target: 300 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2023-04-26
Estimated completion: 2028-05-23
Last updated: 2026-04-13
Interventions
Drug: PasritamigDrug: CetrelimabDrug: CabazitaxelDrug: DocetaxelDrug: ApalutamideDrug: EnzalutamideDrug: DarolutamideDrug: Abiraterone acetate plus prednisone (AAP)Drug: Lutetium Lu-177 vipivotide tetraxetanDrug: JNJ-101556143
Primary outcomes
  • Part 1: Number of Participants With Dose Limiting Toxicity (DLT) (Up to 21 days after first dose of combination agent)
  • Part 1 and Part 2: Number of Participants with Adverse Events (AEs) by Severity (Up to 2 years 11 months)
Sponsor
Janssen Research & Development, LLC · industry
Contacts & investigators
ContactStudy Contact · contact · Participate-In-This-Study1@its.jnj.com · 844-434-4210
InvestigatorJanssen Research & Development, LLC Clinical Trial · study_director, Janssen Research & Development, LLC
All locations (15)
Florida Cancer SpecialistsRecruiting
Sarasota, Florida, United States
Start MidwestRecruiting
Grand Rapids, Michigan, United States
Washington University School Of MedicineRecruiting
St Louis, Missouri, United States
Perlmutter Cancer Center at NYU Langone BrooklynRecruiting
Brooklyn, New York, United States
Laura & Isaac Perlmutter Cancer Center at NYU Langone Hospital - Long IslandRecruiting
Mineola, New York, United States
NYU Langone HealthRecruiting
New York, New York, United States
Sidney Kimmel Cancer Center - Jefferson HealthRecruiting
Philadelphia, Pennsylvania, United States
Icon Cancer Centre Kurralta ParkRecruiting
Kurralta Park, Australia
Macquarie UniversityRecruiting
Macquarie University, Australia
Peter MacCallum Cancer CentreRecruiting
Melbourne, Australia
Princess Alexandra HospitalRecruiting
Woolloongabba, Australia
Hosp Univ Vall D HebronRecruiting
Barcelona, Spain
Hosp Univ Fund Jimenez DiazRecruiting
Madrid, Spain
Hosp. Univ. 12 de OctubreRecruiting
Madrid, Spain
Hosp Univ Hm SanchinarroRecruiting
Madrid, Spain
A Study of Pasritamig (JNJ-78278343) in Combination With Other Agents for Metastatic Prostate Cancer · TrialPath