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NCT05818683PHASE1Recruiting

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

Janssen Research & Development, LLC

Start Date

4/26/2023

Completion Date

5/23/2028

Summary

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

Age Range: 18 years to No maximum

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

Interventions

DRUG

Pasritamig

DRUG

Cetrelimab

DRUG

Cabazitaxel

DRUG

Docetaxel

DRUG

Apalutamide

DRUG

Enzalutamide

DRUG

Darolutamide

DRUG

Abiraterone acetate plus prednisone (AAP)

DRUG

Lutetium Lu-177 vipivotide tetraxetan

DRUG

JNJ-101556143

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Conditions

Metastatic Castration-resistant Prostate NeoplasmsMetastatic Hormone-sensitive Prostate Cancer

Locations

Florida Cancer Specialists

Sarasota, Florida 34232

United States

Start Midwest

Grand Rapids, Michigan 49546

United States

Washington University School Of Medicine

St Louis, Missouri 63110

United States

Perlmutter Cancer Center at NYU Langone Brooklyn

Brooklyn, New York 11223

United States

Laura & Isaac Perlmutter Cancer Center at NYU Langone Hospital - Long Island

Mineola, New York 11501

United States

NYU Langone Health

New York, New York 10016

United States

Sidney Kimmel Cancer Center - Jefferson Health

Philadelphia, Pennsylvania 19107

United States

Icon Cancer Centre Kurralta Park

Kurralta Park, 5037

Australia

Macquarie University

Macquarie University, 2109

Australia

Peter MacCallum Cancer Centre

Melbourne, 3000

Australia

Princess Alexandra Hospital

Woolloongabba, 4102

Australia

Hosp Univ Vall D Hebron

Barcelona, 8035

Spain

Hosp Univ Fund Jimenez Diaz

Madrid, 28040

Spain

Hosp. Univ. 12 de Octubre

Madrid, 28041

Spain

Hosp Univ Hm Sanchinarro

Madrid, 28050

Spain