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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 1/2 study of IDE196 in patients with solid tumors harboring GNAQ/11 mutations or PRKC fusions

Principal Investigator:

Alexander Z. Wei, MD

Contact Number:

212-342-5162

NCT Number:

NCT03947385

Population:

Adult

Phase:

I/II

The purpose of this study is to evaluate the safety profile of IDE196 (an “investigational” drug), in enrolled subjects to find out if it is safe and possibly helpful in patients with certain cancers such as: metastatic uveal melanoma, cutaneous melanoma or colorectal cancer or cancers with mutations in genes called GNAQ, GNA11, or PRKC fusion. The study may last for approximately 25 months and your participation will depend on how well you tolerate the study drug and your overall condition during the study. Are you Eligible? (Inclusion Criteria) Do you have a solid tumor(s) that...
A Phase I/II Study of M3814 and Avelumab in Combination with Hypofractionated Radiation in Patients with Advanced/Metastatic Solid Tumors and Hepatobiliary Malignancies

Principal Investigator:

Susan E. Bates, MD

Contact Number:

212-342-5162

NCT Number:

NCT04068194

Population:

Adult

Phase:

I/II

This study is being done to answer the following question: Is M3814 in combination with radiation therapy and avelumab safe and tolerable in patients with advanced or metastatic cancers. We are doing this study because we want to find out if this approach is better or worse than the usual approach for your advanced or metastatic cancer. The usual approach is defined as care most people get for advanced or metastatic solid tumor. Are you Eligible? (Inclusion Criteria) Are you 18 years of age or older? Do you have a tumor which has spread to other parts of your body or that has advanced and...
A Phase 1/2 Study of Tegavivint (IND#156033, NSC#826393) in Children, Adolescents, and Young Adults with Recurrent or Refractory Solid Tumors, Including Lymphomas and Desmoid Tumors

Principal Investigator:

Nobuko Hijiya, MD

Contact Number:

212-342-5162

NCT Number:

NCT04851119

Population:

Pediatrics/Adult

Phase:

I/II

The purpose of this study is to find out what dose of tegavivint should be used with children and how well it works when given to patients between the ages of 12 months to 30 years of age with refractory or recurrent solid tumors, lymphomas, desmoid tumors, Ewing Sarcomas, osteosarcomas, liver tumors (HCC and hepatoblastoma), Wilm's tumor and tumors with Wnt pathway aberrations. Tegavivint is experimental because it is not approved by the Food and Drug Administration (FDA) for the treatment of children with refractory or recurrent solid tumors, lymphomas, desmoid tumors, Ewing Sarcomas,...
A Phase 1/2 Trial of CBL0137 (NSC# 825802, IND# 155843) in Patients with Relapsed or Refractory Solid Tumors including CNS Tumors and Lymphoma

Principal Investigator:

Nobuko Hijiya, MD

Contact Number:

212-342-5162

NCT Number:

NCT04870944

Population:

Pediatrics/Adult

Phase:

I/II

The purpose of this study is to find the highest dose of CBL0137 that can be given safely to patients with solid tumors that have come back (relapsed) or does not respond to treatment (refractory) solid tumors, including the CNS tumors and lymphoma. CBL0137 will be given into a vein on Day 1 and Day 8 of a 21 day cycle for up to 17 cycles, which will last about 24 months. Are you Eligible? (Inclusion Criteria) Inclusion Criteria: Part A: Patients must be at least 1 year of age and 21 years of age, have been diagnosed with relapsed or refractory relapsed or refractory solid tumors or lymphoma...
An Open-label Phase I/II Trial of Venetoclax-Dexamethasone in Relapsed and/or Refractory t(11;14) Systemic Light-Chain Amyloidosis

Principal Investigator:

Rajshekhar Chakraborty, MD

Contact Number:

212-342-5162

NCT Number:

NCT05451771

Population:

Adult

Phase:

I/II

The purpose of this study is assess safety, safest dose, and effectiveness of venetoclax in combination with dexamethasone in subjects with t(11;14) positive relapsed (comes back) or refractory (did not get better) light chain amyloidosis. Furthermore, the purpose of phase 2 part of this study is to compare the effectiveness of venetoclax and dexamethasone versus investigator’s choice treatment in this condition. Are you Eligible? (Inclusion Criteria) Are you 18 years of age or older? Can you comply with the procedures in this study, which include taking the study drug and extra clinic...
A Phase 1/2 Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of ARV-806 in Participants With KRAS G12D Mutated Advanced Solid Tumors

Principal Investigator:

Linda Y. Wu, MD

Contact Number:

212-342-5162

NCT Number:

NCT07023731

Population:

Adult

Phase:

I/II

The purpose of this study is to test ARV-806 in people who have advanced cancer with KRAS G12D mutation. Advanced cancer is cancer that has spread or come back. KRAS G12D mutation is a change in the cancer DNA that may encourage cancer growth. ARV- 806 is experimental. This means that the Food and Drug Administration (FDA) has not approved the drug for sale or use for the treatment of advanced cancer with KRAS G12D mutation. This study is trying to find out the right dose of the drug that can be given without causing unacceptable side effects. Are you Eligible? (Inclusion Criteria) Written...
A Phase 1b/2 Study of AZD0120 (also known as GC012F), a Chimeric Antigen Receptor T Cell Therapy Targeting CD19 and B cell Maturation Antigen in Participants with Relapsed or Refractory AL Amyloidosis

Principal Investigator:

Suzanne Lentzsch, MD, PhD

Contact Number:

212-342-5162

NCT Number:

NCT07081646

Population:

Adult

Phase:

I/II

The purpose of this study is to learn more about whether AZD0120 is safe to administer to people with relapsed or refractory AL amyloidosis, those who haven't responded well to previous treatments. Relapsed means your AL amyloidosis has returned after a period of improvement. Refractory means your AL amyloidosis has not responded to treatment. We also want to see if AZD0120 can help treat this condition. This study will also help to better understand AL Amyloidosis and associated health problems. Are you Eligible? (Inclusion Criteria) Age greater than 18 years old - ECOG performance status of...
A Phase 1b/2, Open-Label Study of Amivantamab Monotherapy and in Addition to Standard-of-Care Chemotherapy in Participants with Advanced or Metastatic Colorectal Cancer

Principal Investigator:

Yoanna S Pumpalova, MD

Contact Number:

212-342-5162

NCT Number:

NCT05379595

Population:

Adult

Phase:

I/II

The purpose of this study is to see if the study drug,amivantamab (also known as Rybrevant TM) is safe and useful for treating patients with Colorectal Cancer (CRC) when it is given alone or in addition to standard-of-care chemotherapies (mFOLFOX6 or FOLFIRI), as well as to find the best dose of amivantamab when given with chemotherapies. Amivantamab is an antibody made from a protein, designed to target and eliminate a specific harmful object in your body, in this case, a cancer cell. Amivantamab works by targeting a protein in your body known as epidermal growth factor receptor (EGFR), that...
A Phase I/IIa Randomized Clinical trial to Evaluate the Efficacy of EGFR-targeted, PNU159682-packaged Nanocells and Glycolipid-Packaged Nanocells in combination withGemcitabine and Nab-paclitaxel in Metastatic Pancreatic Ductal Adenocarcinoma

Principal Investigator:

Linda Y. Wu, MD

Contact Number:

212-342-5162

NCT Number:

NCT07049055

Population:

Adult

Phase:

I/II

The purpose of this study is to test a new experimental treatment for people with pancreatic cancer that has spread (metastatic PDAC). The experimental treatment being evaluated is called EGFR-targeted EnGeneIC Dream Vector™ (EDV™), carrying a drug called PNU-159682, or E-EDV-D682, referred to as the “study drug.” The study drug is investigational and has not been approved by the United States Food and Drug Administration (FDA). The study drug is a type of chemotherapy packaged inside a delivery vehicle (manufactured from a non–disease- causing salmonella...

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