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Showing 1 - 7 of 7 Trials

A Multinational, Multicenter, Prospective, OpenLabel, Safety and DosimetryStudy of Lutetium-177 (177Lu)Rosopatamab Tetraxetan in Combination withStandard of Care in Patients with Prostate-SpecificMembrane Antigen (PSMA) Positive MetastaticCastration

Principal Investigator:

Mark N. Stein, MD

Contact Number:

212-342-5162

NCT Number:

NCT06520345

Population:

Adult

Phase:

III

This study aims to explore a possible new treatment for advanced prostate cancer that has spread to other parts of the body and tests positive for a specific protein called PSMA (prostate-specific membrane antigen). This treatment involves a special drug that seeks out cancer cells by recognizing PSMA on their surface. The drug combines an antibody— a molecule that can find and attach to specific targets on cancer cells—with a radioactive component. Once attached, it delivers radiation directly to the cancer cells to help destroy them. The drug being studied is called 177Lu-TLX591...
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 I/II Open Label Study to Evaluate the Safety, Cellular Kinetics, and Efficacy of AZD0754, aChimeric Antigen Receptor (CAR) T-cell Therapy Directed Against STEAP2, in Adult Participantswith Metastatic Prostate Cancer: APOLLO

Principal Investigator:

Mark N. Stein, MD

Contact Number:

212-342-5162

NCT Number:

NCT06267729

Population:

Adult

Phase:

I/II

The purpose of this study whether AZD0754 is safe to administer to people with prostate cancer that has spread to other parts of your body (metastatic) and whether it can help to treat their type of cancer. AZD0754 is a type of study treatment called chimeric antigen receptor or CAR T-cell therapy. It uses cells from the subject's own immune system, called T-cells, to attack cancer cells. AZD0754 has not been approved by the Food and Drug Administration (FDA). This is a first in human study. A few days before AZD0754 infusion, the subject will have chemotherapy to lower the number of white...
Phase I/II trial of pembrolizumab and androgen-receptor pathway inhibitor with or without 225Ac-J591 for progressive metastatic castration resistant prostate cancer

Principal Investigator:

Mark N. Stein, MD

Contact Number:

212-342-5162

NCT Number:

NCT04946370

Population:

Adult

Phase:

I/II

The main purpose of this study is to evaluate the maximum tolerated and recommended dose of pembrolizumab and an androgen-receptor pathway inhibitor with or without 225Ac-J591, to see what the side effects are and if they work for metastatic castration resistant prostate cancer. Pembrolizumab may help the body’s immune system fight tumor cells. It does this by keeping certain blood cells, called T cells, active so they can attack the cancer. T-cells are also part of your immune system. Thousands of patients have received pembrolizumab, but it is not approved for most patients with...
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-...
A Phase 1b Platform Study to Evaluate JNJ-78278343-based Therapeutic Combinations for Advanced Prostate Cancer

Principal Investigator:

Mark N. Stein, MD

Contact Number:

212-342-5162

NCT Number:

NCT07082920

Population:

Adult

Phase:

I

The purpose of this study is to find a safe dose of investigational study drug, JNJ- 95298177 when given in combination with investigational drug, JNJ-78278343 in patients with prostate cancer. JNJ-78278343 and JNJ-95298177 are not approved by the United States Food and Drug Administration (FDA). The sponsor, Janssen Research & Development, provides the investigational study treatment, called “JNJ-78278343 and JNJ-95298177”. This is the first time that JNJ-78278343 is being used in combination with JNJ-95298177. Are you Eligible? (Inclusion Criteria) At the time of informed...
A Phase 3 Randomized, Double-blind, Placebo-controlled Study of Pasritamig (JNJ-78278343), a T-cell-redirecting Agent Targeting Human Kallikrein 2, + Best SupportiveCare Versus Best Supportive Care for Metastatic Castration-resistant Prostate Cancer

Principal Investigator:

Mark N. Stein, MD

Contact Number:

212-342-5162

NCT Number:

NCT07164443

Population:

Adult

Phase:

NA

The purpose of this study is to understand if a treatment (pasritamig) added to best supportive care (including radiation, steroids, pain medication, or medications to strengthen your bones) for metastatic castration-resistant prostate cancer (a form of advanced prostate cancer that has spread to other parts of the body) will work better than the best supportive care alone. The investigational study treatment is called pasritamig. Pasritamig is not approved by U.S. Food and Drug Administration (FDA) who are responsible to approve medications. Therefore, it can only be used in a research study...

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