NCT05818683

Brief 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).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for phase_1

Timeline
25mo left

Started Apr 2023

Longer than P75 for phase_1

Geographic Reach
3 countries

15 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress60%
Apr 2023May 2028

First Submitted

Initial submission to the registry

April 6, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 19, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

April 26, 2023

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2027

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 23, 2028

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

4.4 years

First QC Date

April 6, 2023

Last Update Submit

April 9, 2026

Conditions

Metastatic Hormone-sensitive Prostate CancerMetastatic Castration-resistant Prostate Neoplasms

Outcome Measures

Primary Outcomes (2)

  • Part 1: Number of Participants With Dose Limiting Toxicity (DLT)

    DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity or hematologic toxicity.

    Up to 21 days after first dose of combination agent

  • Part 1 and Part 2: Number of Participants with Adverse Events (AEs) by Severity

    An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 with the exception of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome events, which will be graded by American Society for Transplantation and Cellular Therapy (ASTCT) guidelines. Severity scale ranges from grade 1 (mild) to grade 5 (death). Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening and Grade 5= death related to adverse event.

    Up to 2 years 11 months

Secondary Outcomes (6)

  • Overall Response Rate (ORR)

    Up to 2 years 11 months

  • Prostate Specific Antigen (PSA) Response Rate

    Up to 2 years 11 months

  • Radiographic Progression-free Survival (rPFS)

    Up to 2 years 11 months

  • Time to Response (TTR)

    Up to 2 years 11 months

  • Duration of Response (DOR)

    Up to 2 years 11 months

  • +1 more secondary outcomes

Study Arms (1)

JNJ-78278343 + Combination agent: Part 1 (Dose Escalation) and Part 2 (Dose Expansion)

EXPERIMENTAL

Participants will receive pasritamig (JNJ-78278343) and combination agent (cetrelimab, cabazitaxel, docetaxel, apalutamide, enzalutamide, Darolutamide, abiraterone acetate plus prednisone, Lutetium Lu-177 vipivotide tetraxetan and JNJ-101556143) during Part 1 (dose escalation). The dose of pasritamig (JNJ-78278343) will be escalated sequentially until a recommended phase 2 regimen (RP2R). Participants will receive pasritamig (JNJ-78278343) and combination agent treatment at the putative RP2R in Part 2 (dose expansion).

Drug: PasritamigDrug: CetrelimabDrug: CabazitaxelDrug: DocetaxelDrug: ApalutamideDrug: EnzalutamideDrug: DarolutamideDrug: Abiraterone acetate plus prednisone (AAP)Drug: Lutetium Lu-177 vipivotide tetraxetanDrug: JNJ-101556143

Interventions

DocetaxelDRUG

Docetaxel will be administered by intravenous infusion.

JNJ-78278343 + Combination agent: Part 1 (Dose Escalation) and Part 2 (Dose Expansion)
ApalutamideDRUG

Apalutamide will be administered orally.

JNJ-78278343 + Combination agent: Part 1 (Dose Escalation) and Part 2 (Dose Expansion)
EnzalutamideDRUG

Enzalutamide will be administered orally.

JNJ-78278343 + Combination agent: Part 1 (Dose Escalation) and Part 2 (Dose Expansion)
DarolutamideDRUG

Darolutamide will be administered orally.

JNJ-78278343 + Combination agent: Part 1 (Dose Escalation) and Part 2 (Dose Expansion)
CetrelimabDRUG

Cetrelimab will be administered by intravenous infusion.

Also known as: JNJ-63723283
JNJ-78278343 + Combination agent: Part 1 (Dose Escalation) and Part 2 (Dose Expansion)
CabazitaxelDRUG

Cabazitaxel will be administered by intravenous infusion.

JNJ-78278343 + Combination agent: Part 1 (Dose Escalation) and Part 2 (Dose Expansion)
PasritamigDRUG

Pasritamig will be administered.

Also known as: JNJ-78278343
JNJ-78278343 + Combination agent: Part 1 (Dose Escalation) and Part 2 (Dose Expansion)
Abiraterone acetate plus prednisone (AAP)DRUG

Abiraterone acetate plus prednisone (AAP) will be administered orally.

JNJ-78278343 + Combination agent: Part 1 (Dose Escalation) and Part 2 (Dose Expansion)
Lutetium Lu-177 vipivotide tetraxetanDRUG

Lutetium Lu-177 vipivotide tetraxetan will be administered intravenously.

JNJ-78278343 + Combination agent: Part 1 (Dose Escalation) and Part 2 (Dose Expansion)
JNJ-101556143DRUG

JNJ-101556143 will be administered orally.

JNJ-78278343 + Combination agent: Part 1 (Dose Escalation) and Part 2 (Dose Expansion)

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Florida Cancer Specialists

Sarasota, Florida, 34232, United States

RECRUITING

Start Midwest

Grand Rapids, Michigan, 49546, United States

RECRUITING

Washington University School Of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Perlmutter Cancer Center at NYU Langone Brooklyn

Brooklyn, New York, 11223, United States

RECRUITING

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

Mineola, New York, 11501, United States

RECRUITING

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

Sidney Kimmel Cancer Center - Jefferson Health

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Icon Cancer Centre Kurralta Park

Kurralta Park, 5037, Australia

RECRUITING

Macquarie University

Macquarie University, 2109, Australia

RECRUITING

Peter MacCallum Cancer Centre

Melbourne, 3000, Australia

RECRUITING

Princess Alexandra Hospital

Woolloongabba, 4102, Australia

RECRUITING

Hosp Univ Vall D Hebron

Barcelona, 8035, Spain

RECRUITING

Hosp Univ Fund Jimenez Diaz

Madrid, 28040, Spain

RECRUITING

Hosp. Univ. 12 de Octubre

Madrid, 28041, Spain

RECRUITING

Hosp Univ Hm Sanchinarro

Madrid, 28050, Spain

RECRUITING

MeSH Terms

Interventions

cabazitaxelDocetaxelapalutamideenzalutamidedarolutamideAbiraterone AcetatePrednisone

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsPregnadienediolsPregnadienesPregnanes

Study Officials

  • Janssen Research & Development, LLC Clinical Trial

    Janssen Research & Development, LLC

    STUDY DIRECTOR

Central Study Contacts

Study Contact

CONTACT

844-434-4210Participate-In-This-Study1@its.jnj.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2023

First Posted

April 19, 2023

Study Start

April 26, 2023

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

May 23, 2028

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

The data sharing policy of Johnson \& Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

More information

Locations

AU(4)ES(4)US(7)