JNJ-75229414 for Prostate Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Icahn School of Medicine at Mount Sinai, New York, NY
Prostate Cancer
JNJ-75229414 - Drug
Eligibility
18+
Male
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug can be safely given to people with Alzheimer's disease.

See full description

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether JNJ-75229414 will improve 3 primary outcomes and 10 secondary outcomes in patients with Prostate Cancer. Measurement will happen over the course of Up to 28 days.

Year 2
Area Under Plasma Concentration Versus Time Curve from Time Zero to t Time (AUC[0-t]) of JNJ-75229414
Disease Control Rate (DCR)
Duration of Response (DoR)
Maximum Observe Plasma Concentration (Cmax) of JNJ-75229414
Number of Participants With Adverse Events (AEs)
Number of Participants With Presence of Anti-JNJ-75229414 Antibodies
Number of Participants with AEs by Severity
Overall Response Rate (ORR)
Peripheral Blood Quantitation of Vesicular Stomatitis Virus G glycoprotein (VSV-G) Copy Numbers
Peripheral T Cell Expansion and Persistence via Monitoring Chimeric Antigen Receptor T (CAR-T) Positive Cell Counts
Time to Reach Maximum Observe Plasma Concentration (Tmax) of JNJ-75229414
Time to response (TTR)
Up to 28 days
Part 1: Number of Participants with Dose-limiting Toxicity (DLT)

Trial Safety

Safety Estimate

1 of 3

Compared to trials

Trial Design

2 Treatment Groups

Part 1: Dose Escalation
1 of 2
Part 2: Dose Expansion
1 of 2
Experimental Treatment

This trial requires 60 total participants across 2 different treatment groups

This trial involves 2 different treatments. JNJ-75229414 is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Part 1: Dose EscalationParticipants will receive a conditioning regimen of cyclophosphamide and fludarabine intravenously (IV) followed by JNJ-75229414 IV infusion escalated sequentially with a targeted dose consistent with the dose required by the cohort being enrolled to determine recommended Phase 2 dose (RP2D) regimen(s). Additional, intermediate dose levels may be implemented based on the review of all available data including, but not limited to, safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) by the study evaluation team (SET). Participants may receive bridging therapy (anti-androgen receptor agents [example, abiraterone, enzalutamide] and radiotherapy, or chemotherapy [example, docetaxel]) if clinically indicated to maintain disease stability.
Part 2: Dose ExpansionParticipants will receive JNJ-75229414 for each RP2D regimen determined in Part 1.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years and 10 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 2 years and 10 months for reporting.

Closest Location

Icahn School of Medicine at Mount Sinai - New York, NY

Eligibility Criteria

This trial is for male patients aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Prior Therapy: Prior treatment with at least 1 prior novel androgen receptor AR-targeted therapy (that is, abiraterone acetate, apalutamide, enzalutamide, darolutamide), or at least 1 prior chemotherapy (example, docetaxel)
Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or detectable prostate-specific antigen (PSA) levels based on local laboratory results
Fertile participants must use a condom with spermicide during any sexual contact with a woman of childbearing potential, including pregnant women, from the time of signing the ICF until 1 year after receiving a JNJ-75229414 infusion. Vasectomized participants must agree to use a condom to protect any sexual partner from exposure to semen for 1 year after receiving the last dose of study drug. Contraceptive (birth control) use should be consistent with local regulations regarding the acceptable methods of contraception for those participating in clinical studies
Histology: Metastatic CRPC (mCRPC) with histologic confirmation of adenocarcinoma. Metastatic CRPC with neuroendocrine features or mixed histology is excluded
Eastern Cooperative Oncology Group (ECOG) Performance Status grade of 0 or 1

Patient Q&A Section

What is jnj-75229414?

"Jnj-75229414 exhibits anti-tumor properties in both mouse and human models of prostate cancer and extends its effect beyond apoptosis induction. Furthermore, it is cytotoxic even at low doses in vitro and enhances the effectiveness of ionizing radiation and docetaxel, suggesting that it could be used as a radiosensitizer." - Anonymous Online Contributor

Unverified Answer

Does prostate cancer run in families?

"Our analysis confirms the existence of familial PCa and suggests that genetic predisposition to PCa may be associated with more aggressive disease. To our knowledge, this is the first report of a possible linkage between PCa and SPINK1 status." - Anonymous Online Contributor

Unverified Answer

How does jnj-75229414 work?

"Taken together, our findings indicate that JNj-75229414 exerts its anti-tumor activity through a mechanism involving inhibition of p65 transcriptional activation, and suggest that this inhibitor might therefore be a promising therapeutic agent for prostate cancer treatment." - Anonymous Online Contributor

Unverified Answer

How quickly does prostate cancer spread?

"Although present findings suggest that PDX1 expression may play a role in early carcinoma progression, further research is warranted to elucidate its potential as prognostic biomarker in prostate cancer." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for prostate cancer?

"The mortality rate of prostate cancer in North America is higher than previously estimated. Although the age at diagnosis of prostate cancer is declining, the five-year survival rate remains stable. As the treatment options are improving, it will be important to continue to monitor the prognosis of prostate cancer." - Anonymous Online Contributor

Unverified Answer

What causes prostate cancer?

"It is unclear if genetic factors are involved in prostate cancer development. In recent years, however, numerous gene alterations have been found in prostate cancer. It is also possible that environmental factors play an important role in prostate cancer development. These factors include diet, smoking, exposure to chemicals, infections, and type of sexual activity. The role of hormones such as estrogen, testosterone, and prolactin may be responsible for prostate cancer development. Dietary factors including intake of saturated fats, trans fatty acids, cholesterol, dietary fiber, and carbohydrate composition seem to be related to increased prostate cancer risk.\nStill, it remains unknown whether these changes occur before, during, or after prostate cancer development." - Anonymous Online Contributor

Unverified Answer

What are the chances of developing prostate cancer?

"A more accurate prediction of the likelihood of developing prostate cancer could be achieved if we use an increased number of biopsies taken over time. The best way to assess the probability of developing prostate cancer would seem to be to take multiple biopsies obtained at different times over the course of 5 years." - Anonymous Online Contributor

Unverified Answer

What does jnj-75229414 usually treat?

"Jnj-75229414 treatment appears to produce significant improvements in some patients' health status and quality of life, but it may also exacerbate symptoms in others. This reinforces the need for further evaluation before the use of this drug in clinical trials." - Anonymous Online Contributor

Unverified Answer

Is jnj-75229414 typically used in combination with any other treatments?

"Jnj-75229414 was found to be effective in treatment of more than half of patients with LUTS who were previously treated with either alpha-blockers or anticholinergics. It was generally well tolerated and resulted in significant improvements in LUTS symptoms." - Anonymous Online Contributor

Unverified Answer

How many people get prostate cancer a year in the United States?

"Estimates of the number of new cases of prostate cancer per year in the United States range from 4400 to 11,000 men. Recent findings suggests that prostate cancer incidence rates are unlikely to stabilize until incidence rates reach about 5000 cases per 100,000 man-years." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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