Metastatic Castration-resistant Prostate Neoplasms, Metastatic Hormone-sensitive Prostate Cancer
Conditions
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).
Interventions
DRUGPasritamig
Pasritamig will be administered.
DRUGCetrelimab
Cetrelimab will be administered by intravenous infusion.
DRUGCabazitaxel
Cabazitaxel will be administered by intravenous infusion.
DRUGDocetaxel
Docetaxel will be administered by intravenous infusion.
DRUGApalutamide
Apalutamide will be administered orally.
DRUGEnzalutamide
Enzalutamide will be administered orally.
DRUGDarolutamide
Darolutamide will be administered orally.
DRUGAbiraterone acetate plus prednisone (AAP)
Abiraterone acetate plus prednisone (AAP) will be administered orally.
DRUGLutetium Lu-177 vipivotide tetraxetan
Lutetium Lu-177 vipivotide tetraxetan will be administered intravenously.
DRUGJNJ-101556143
JNJ-101556143 will be administered orally.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate (ORR) | Up to 2 years 11 months | ORR is defined as the percentage of participants who have a partial response (PR) or better without evidence of bone progression according to Prostate Cancer Working Group 3 (PCWG3) criteria. |
| Prostate Specific Antigen (PSA) Response Rate | Up to 2 years 11 months | PSA response rate is defined as the percentage of participants with a confirmed decline of PSA of 50 percent (%) or more from baseline. |
| Radiographic Progression-free Survival (rPFS) | Up to 2 years 11 months | rPFS is defined time from the date of first dose of pasritamig until the date of objective disease progression or death, whichever comes first. |
| Time to Response (TTR) | Up to 2 years 11 months | TTR is defined for the responders as the time from the date of first dose of to the date of first documented response that is subsequently confirmed. |
| Duration of Response (DOR) | Up to 2 years 11 months | DOR is defined for participants who achieved response (PR or better) as the time between the date of initial documentation of response (PR or better) to the date of first documented evidence of progressive disease, as defined in the PCWG3, or death due to any cause, whichever occurs first. |
| Part 2H Metastatic hormone-sensitive prostate cancer (mHSPC) Participants : Composite Progression-Free Survival (PFS) | Up to 2 years 11 months | Composite PFS is defined as time from start of treatment to the date of first occurrence of investigator determined disease progression (Response Evaluation Criteria in Solid Tumors \[RECIST\] or bone progression), pain, PSA progression, death or last disease assessment. |
Countries
Australia, Spain, United States
Contacts
CONTACTStudy Contact
STUDY_DIRECTORJanssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Outcome results
None listed