Pasritamig
DrugPasritamig will be administered.
Other names: JNJ-78278343
NCT Number: NCT05818683
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).
Interested in participating?
Request Info18 year and older
Male
Interventional
Phase 1
Icon Cancer Centre Kurralta Park, Kurralta Park, Australia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Pasritamig will be administered.
Other names: JNJ-78278343
Cetrelimab will be administered by intravenous infusion.
Other names: JNJ-63723283
Cabazitaxel will be administered by intravenous infusion.
Docetaxel will be administered by intravenous infusion.
Apalutamide will be administered orally.
Enzalutamide will be administered orally.
Darolutamide will be administered orally.
Abiraterone acetate plus prednisone (AAP) will be administered orally.
Lutetium Lu-177 vipivotide tetraxetan will be administered intravenously.
JNJ-101556143 will be administered orally.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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 frame: 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.
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Janssen Research & Development, LLC
Industry
A Phase 1b Study of JNJ-78278343, Targeting Human Kallikrein 2 (KLK2) in Combination With Other Agents for Metastatic Prostate Cancer
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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