Recruiting
Phase 1
A Study of Pasritamig (JNJ-78278343) in Combination With Other Agents for Metastatic Prostate Cancer
Condition(s) studied
Metastatic Castration-resistant Prostate NeoplasmsMetastatic Hormone-sensitive Prostate Cancer
Investigational drug(s) / intervention(s)
Pasritamig: Pasritamig will be administered.
Cetrelimab: Cetrelimab will be administered by intravenous infusion.
Cabazitaxel: Cabazitaxel will be administered by intravenous infusion.
Docetaxel: Docetaxel will be administered by intravenous infusion.
Apalutamide: Apalutamide will be administered orally.
Enzalutamide: Enzalutamide will be administered orally.
Darolutamide: Darolutamide will be administered orally.
Abiraterone acetate plus prednisone (AAP): Abiraterone acetate plus prednisone (AAP) will be administered orally.
Lutetium Lu-177 vipivotide tetraxetan: Lutetium Lu-177 vipivotide tetraxetan will be administered intravenously.
JNJ-101556143: JNJ-101556143 will be administered orally.
Study 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
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
Primary outcome measure(s)
- Part 1: Number of Participants With Dose Limiting Toxicity (DLT) — Up to 21 days after first dose of combination agent
DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity or hematologic toxicity.
- Part 1 and Part 2: Number of Participants with Adverse Events (AEs) by Severity — Up to 2 years 11 months
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.
Trial sites (15)
| Facility | City | Region | Status |
| Florida Cancer Specialists |
Sarasota |
Florida |
Recruiting |
| Start Midwest |
Grand Rapids |
Michigan |
Recruiting |
| Washington University School Of Medicine |
St Louis |
Missouri |
Recruiting |
| Perlmutter Cancer Center at NYU Langone Brooklyn |
Brooklyn |
New York |
Recruiting |
| Laura & Isaac Perlmutter Cancer Center at NYU Langone Hospital - Long Island |
Mineola |
New York |
Recruiting |
| NYU Langone Health |
New York |
New York |
Recruiting |
| Sidney Kimmel Cancer Center - Jefferson Health |
Philadelphia |
Pennsylvania |
Recruiting |
| Icon Cancer Centre Kurralta Park |
Kurralta Park |
Australia |
Recruiting |
| Macquarie University |
Macquarie University |
Australia |
Recruiting |
| Peter MacCallum Cancer Centre |
Melbourne |
Australia |
Recruiting |
| Princess Alexandra Hospital |
Woolloongabba |
Australia |
Recruiting |
| Hosp Univ Vall D Hebron |
Barcelona |
Spain |
Recruiting |
| Hosp Univ Fund Jimenez Diaz |
Madrid |
Spain |
Recruiting |
| Hosp. Univ. 12 de Octubre |
Madrid |
Spain |
Recruiting |
| Hosp Univ Hm Sanchinarro |
Madrid |
Spain |
Recruiting |
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