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A Phase 1 Study of JNJ-87189401 (PSMA-CD28 Bispecific Antibody) Combined with JNJ 78278343 (KLK2-CD3 Bispecific Antibody) for Advanced Prostate Cancer

Principal Investigator:

Mark N. Stein, MD

Contact Number:

212-342-5162

NCT Number:

NCT06095089

Population:

Adult

Phase:

I

The purpose of this study is to find out the side effects of JNJ-87189401 given in combination with JNJ-78278343 to patients with metastatic castration-resistant prostate cancer, and to find which doses of the two study drugs when given in combination cause the least side effects. The study will also look at how long JNJ-87189401 and JNJ-78278343 stay in the body, how they act on the body, and how the body responds to them. JNJ-87189401 and JNJ-78278343 have not been approved by the Food and Drug Administration (FDA). This is the first time that JNJ-87189401 will be used in people. JNJ-...
Phase II single arm study testing SBRT, Adenosine signaling Modulation (AB680, AB928), and Immune Checkpoint inhibition (AB122) for men with hormone sensitive Oligometastatic prostate cancer (SBRT-AMICO)

Principal Investigator:

Catherine S Spina, MD, PhD

Contact Number:

212-342-5162

NCT Number:

NCT05915442

Population:

Adult

Phase:

II

This study aims to test the safety and effectiveness of zimberelimab, etrumadenant, and quemliclustat when given together with radiotherapy as a potential treatment to hormone sensitive oligometastatic (cancer that has spread to other areas of the body) prostate cancer. Zimberelimab, etrumadenant, and quemliclustat are considered immunotherapy drugs. These type of drug works by blocking a protein that can cause tumors to grow. By blocking this protein, the study drugs may cause your cancer to stop growing or to shrink. These study drugs are not approved by Health Authorities including the...
A Phase 3, Open-label, Randomized, Prospective Study of Apalutamide with ContinuedVersus Intermittent Androgen-Deprivation Therapy (ADT) following PSA Response inParticipants with Metastatic Castration-Sensitive Prostate Cancer (mCSPC)

Principal Investigator:

Karie Danielle Keera Runcie, MD

Contact Number:

212-342-5162

NCT Number:

NCT05884398

Population:

Adult

Phase:

III

The purpose of this study is to help researchers understand more about the possible effectiveness and safety of apalutamide when given to patients with or without intermittent Androgen Deprivation Therapy (ADT) to treat metastatic Castration-Sensitive Prostate Cancer (mCSPC). Apalutamide is a type of drug that blocks the action of testosterone. By blocking the action of testosterone, it may slow down or stop the growth of prostate cancer cells. ADT works by stopping the body’s production of testosterone. The reason for using ADT is that prostate cancer needs androgen to grow and survive...
Randomized Study of ONC-392 plus Lutetium Lu 177 Vipivotide Tetraxetan in Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC) who Progressed on Androgen Receptor (AR) Pathway Inhibition

Principal Investigator:

Mark N. Stein, MD

Contact Number:

212-342-5162

NCT Number:

NCT05682443

Population:

Adult

Phase:

I/II

The main purpose of the study is to determine whether the study drug, ONC-392, together with a standard of care drug PLUVICTO® (Lutetium Lu 177 Vipivotide Tetraxetan), are safe and well tolerated, and whether two drugs are effective in treating prostate cancer, in comparison with the standard of care PLUVICTO® alone. ONC-392 has not yet been approved by the Food and Drug Administration (FDA). PLUVICTO® is FDA approved but is not approved to be combined with ONC-392. Are you Eligible? (Inclusion Criteria) Male 18 years or older -Confirmed prostate adenocarcinoma -Have had previous...
A PHASE 1/2 STUDY OF REGN5678 (ANTI-PSMAXCD28) WITH OR WITHOUT CEMIPLIMAB (ANTI-PD-1) IN PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER AND OTHER TUMORS ASSOCIATED WITH PSMA EXPRESSION

Principal Investigator:

Mark N. Stein, MD

Contact Number:

212-342-5162

NCT Number:

NCT03972657

Population:

Adult

Phase:

I/II

The purpose of this study is to determine the safety, tolerability (how your body reacts to the drug) and effectiveness of REGN5678 which will be given alone first and then be given in combination with cemiplimab. Neither REGN5678 nor Cemiplimab is FDA approved to treat your type of cancer. Cemiplimab is approved by the FDA for the treatment of certain types of metastatic cutaneous squamous cell carcinoma (CSCC) (one of the main types of skin cancer ) or locally advanced CSCC (who are not candidates for curative surgery or curative radiation). REGN5678 has not yet been studied in people. Are...
A Phase 3, Multicenter, Open-label Study to Test the Diagnostic Performance of Copper Cu 64 PSMA IT PET/CT in Staging of Men with Newly Diagnosed Unfavorable Intermediate-risk, High-risk or Very High-risk Prostate Cancer Electing to Undergo Radical

Principal Investigator:

Mark N. Stein, MD

Contact Number:

212-342-5162

NCT Number:

NCT06235151

Population:

Adult

Phase:

III

The purpose of this research study is to see how safe and effective the use of copper Cu 64 PSMA I&T Injection is in imaging prostate cancer tumors for staging of men with newly diagnosed intermediate or high risk prostate cancer. Copper Cu 64 PSMA I&T Injection is an investigational imaging agent, given to you through your vein (intravenous (IV)), that makes tumors from prostate cancer show up during a nuclear medicine imaging scan. The imaging scan is a type of nuclear medicine imaging test, which means it uses a radioactive drug (a drug that contains a radioactive substance and is...
DISRUPT: Aim 2

Principal Investigator:

Benjamin Herzberg, MD

Contact Number:

212-342-5162

NCT Number:

NCT05146297

Population:

Adult

Phase:

NA

That Black, Indigenous, and People of Color (BIPOC) are more likely to die from their cancer is well known. Despite years of progress in cancer research and treatment, most research is done in white populations. For this reason, it is not certain how best to treat BIPOC with cancer. The number of people with cancer who join a clinical trial (CT) in the United States at 8%. This low number is due to many reasons including the things related to the healthcare system, the number and type of clinical trials that are available, and the other illnesses patients have. These factors affect BIPOC...
A Phase II Study of Ipilimumab, Cabozantinib, and Nivolumab in Rare Genitourinary Cancers (ICONIC)

Principal Investigator:

Mark N. Stein, MD

Contact Number:

212-342-5162

NCT Number:

NCT03866382

Population:

Adult

Phase:

II

This purpose of this study is to test the effectiveness of cabozantinib with nivolumab and ipilimumab in rare genitourinary cancers that have no standard treatment options. Are you Eligible? (Inclusion Criteria) Do you have confirmed diagnosis of one of the following cancers? -small cell carcinoma of the bladder; -adenocarcinoma of the bladder; -squamous cell carcinoma of the bladder; -plasmacytoid urothelial carcinoma; -any penile cancer; -sarcomatoid renal cell carcinoma; -sarcomatoid urothelial carcinoma; -renal medullary carcinoma or other miscellaneous histologic variants of the...
An Open Label, Phase 1, Treatment Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of IDE397 (MAT2A Inhibitor) In Adult Participants with Advanced Solid Tumors

Principal Investigator:

Benjamin Herzberg, MD

Contact Number:

212-342-5162

NCT Number:

NCT04794699

Population:

Adult

Phase:

I

IDE397 is an investigational drug, which has not been approved by health authorities for the treatment of people with your medical condition. It is currently not “on the market” (available for you to receive a prescription for and/or to buy) in any country. In this study, different dose levels of IDE397 will be tested. About 40 patients are expected to participate at approximately 6-8 study centers within the US. At a minimum, 2 patients will be enrolled in each dose level. There will be about 10 dose levels tested (starting at 5 mg). Every time a dose level is found to be safe, a...
An Open-Label, Multicenter Study of LY4050784, a Selective SMARCA2/BRM Inhibitor, inAdvanced Solid Tumor Malignancies with SMARCA4/BRG1 Alterations- J5M-OX-JOXA

Principal Investigator:

Benjamin Herzberg, MD

Contact Number:

212-342-5162

NCT Number:

NCT06561685

Population:

Adult

Phase:

I

The purpose of this study is to test the safety of an investigational treatment called LY4050784 in subjects with solid tumors that have a particular genetic abnormality (called an alteration or mutation) of a gene called SMARCA4 and/or BRG1. LY4050784 is an investigational (or experimental) drug, taken by mouth that targets a gene called SMARCA2/BRM, and may treat certain cancers. Investigational means neither the FDA nor any other health or regulatory authority in other countries have approved LY4050784. This study will be the first time LY4050784 will be tested in humans. Are you Eligible...

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