Recruiting NCT05818683
A Study of Pasritamig (JNJ-78278343) in Combination With Other Agents for Metastatic Prostate Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pasritamig, Cetrelimab, Cabazitaxel, Docetaxel.
- Who it may be relevant to
- Registry conditions: Metastatic Castration-resistant Prostate Neoplasms, Metastatic Hormone-sensitive Prostate Cancer. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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).
Interventions
- Drug Pasritamig
Pasritamig will be administered. - Drug Cetrelimab
Cetrelimab will be administered by intravenous infusion. - Drug Cabazitaxel
Cabazitaxel will be administered by intravenous infusion. - Drug Docetaxel
Docetaxel will be administered by intravenous infusion. - Drug Apalutamide
Apalutamide will be administered orally. - Drug Enzalutamide
Enzalutamide will be administered orally. - Drug Darolutamide
Darolutamide will be administered orally. - Drug Abiraterone acetate plus prednisone (AAP)
Abiraterone acetate plus prednisone (AAP) will be administered orally. - Drug Lutetium Lu-177 vipivotide tetraxetan
Lutetium Lu-177 vipivotide tetraxetan will be administered intravenously. - Drug JNJ-101556143
JNJ-101556143 will be administered orally.
Primary outcome measures
- Part 1: Number of Participants With Dose Limiting Toxicity (DLT) [Time frame: Up to 21 days after first dose of combination agent]
- Part 1 and Part 2: Number of Participants with Adverse Events (AEs) by Severity [Time frame: Up to 2 years 11 months]
Secondary outcome measures (6)
- Overall Response Rate (ORR) [Time frame: Up to 2 years 11 months]
- Prostate Specific Antigen (PSA) Response Rate [Time frame: Up to 2 years 11 months]
- Radiographic Progression-free Survival (rPFS) [Time frame: Up to 2 years 11 months]
- Time to Response (TTR) [Time frame: Up to 2 years 11 months]
- Duration of Response (DOR) [Time frame: Up to 2 years 11 months]
- Part 2H Metastatic hormone-sensitive prostate cancer (mHSPC) Participants : Composite Progression-Free Survival (PFS) [Time frame: Up to 2 years 11 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 7 centers
- Florida Cancer Specialists — Sarasota
- Start Midwest — Grand Rapids
- Washington University School Of Medicine — St Louis
- Perlmutter Cancer Center at NYU Langone Brooklyn — Brooklyn
- Laura & Isaac Perlmutter Cancer Center at NYU Langone Hospital - Long Island — Mineola
- NYU Langone Health — New York
- Sidney Kimmel Cancer Center - Jefferson Health — Philadelphia
Australia · 4 centers
- Icon Cancer Centre Kurralta Park — Kurralta Park
- Macquarie University — Macquarie University
- Peter MacCallum Cancer Centre — Melbourne
- Princess Alexandra Hospital — Woolloongabba
Spain · 4 centers
- Hosp Univ Vall D Hebron — Barcelona
- Hosp Univ Fund Jimenez Diaz — Madrid
- Hosp. Univ. 12 de Octubre — Madrid
- Hosp Univ Hm Sanchinarro — Madrid
Identifiers
NCT: NCT05818683 · CR109321 · 78278343PCR1003 · 2022-503132-14-00