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Showing 1 - 10 of 11 Trials

A Phase 1/2 Study to Evaluate STK 012 as a Single Agent and in Combination Therapy in Subjects with Front-line Advanced NSCLC and Other Selected Indications

Principal Investigator:

Benjamin Izar, MD, PhD

Contact Number:

212-342-5162

NCT Number:

NCT05098132

Population:

Adult

Phase:

I

The main purpose of this study is to determine the highest dose of STK-012 that can be given safely alone and in combination with a standard dose of pembrolizumab in subjects with advanced solid tumors, this will be assessed in the dose escalation phase of the study. In the dose expansion phase of the study, the highest dose of STK-012 that can be safely given in combination with pembrolizumab, as determined in the dose escalation phase, will be given to more people for further study.STK-012 is a modified (changed in the laboratory) form of a cytokine (protein) called interleukin-2 (IL-2)...
A Phase 1 Basket Study Evaluating the Safety and Feasibility of T-Plex, Autologous Customized T Cell Receptor-Engineered T Cells Targeting Multiple Peptide/HLA Antigens in Participants with Antigen-positive Locally Advanced (Unresectable) or Metastatic

Principal Investigator:

Brian Henick, MD

Contact Number:

212-342-5162

NCT Number:

NCT05973487

Population:

Adult

Phase:

I

The purpose of the study is to learn if the study treatments TSC-204-A0201, TSC 200- A020, and TSC-204-C0702 alone or in combination, referred to as T-Plex, are safe and effective in treating your type of cancer. T-Plex has not yet been approved by the Food and Drug Administration (FDA). This is a first-in-human study, which means that these products have never been administered to humans before. You are unlikely to benefit from taking part in this study. Are you Eligible? (Inclusion Criteria) Must be 18 years or older - Diagnosed with a locally advanced (unresectable) or metastatic solid...
A Phase II, Multicenter, Open-Label Trial of DB-1311 in combination with BNT327 or DB1305 inParticipants with Advanced/Metastatic Solid Tumors

Principal Investigator:

Brian Henick, MD

Contact Number:

212-342-5162

NCT Number:

NCT06953089

Population:

Adult

Phase:

I

The purpose of this study is to test whether combining two investigational study drugs, DB-1311 with BNT327 or DB-1311 with DB-1305, is safe and can be tolerated by participants with advanced or metastatic solid tumors. The study will also test how much of the study drugs are in the blood at different times, if the body makes antibodies against the study drugs, and how the study drugs affect the disease. Additionally, the study may also explore how certain molecules in the blood or tissue (biomarkers) relate to the drug's effects. DB-1311, BNT327, and DB-1305 are investigational drugs,...
LuMIERE: A Phase 1/2, Multicenter, Open-label, Non-randomized Study to Investigate Safety and Tolerability, Pharmacokinetics, Dosimetry, and Preliminary Activity of [177Lu]Lu-FAP-2286 in Patients with an Advanced Solid Tumor

Principal Investigator:

Ryan H. Moy, MD, PhD

Contact Number:

212-342-5162

NCT Number:

NCT04939610

Population:

Adult

Phase:

I/II

The purpose of this study is to test the safety of the experimental drugs called 68Ga-FAP-2286 and 177Lu-FAP-2286. 8Ga-FAP-2286 is an imaging agent that targets a certain protein which has been found in certain tumors called Fibroblast activation protein (FAP). Imaging using 68Ga-FAP-2286 will determine if participants are eligible to receive the experimental radiotherapy, 177Lu-FAP-2286, which researchers think may kill cancer cells by delivering radiation to cancer cells that have fibroblast activation protein (FAP). Are you Eligible? (Inclusion Criteria) Have you been diagnosed with...
A Multicenter Open-Label Study of RMC-6236 in Patients with Advanced Solid Tumors Harboring Specific Mutations in KRAS

Principal Investigator:

Benjamin Herzberg, MD

Contact Number:

212-342-5162

NCT Number:

NCT05379985

Population:

Pediatrics/Adult

Phase:

I

The purpose of this study is to test an experimental drug called RMC-6236 (the study drug) for solid tumor cancer with a KRAS mutation. The KRAS protein sends signals that cause cancer cells to grow. RMC-6236 is designed to prevent the KRAS protein from sending these signals, and this blocking action may slow or stop the growth of your cancer cells. RMC-6236 is an experimental drug, which means that it is not approved by the United States (US) Food and Drug Administration (FDA) or any other health authorities. This is the first study in which RMC-6236 will be tested in humans. The safety of...
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 ASP1570 as Monotherapy and in Combination with Pembrolizumab orStandard Therapies Including Chemotherapy and/or Immunotherapy in Participants with LocallyAdvanced or Metastatic Solid Tumors

Principal Investigator:

Ryan H. Moy, MD, PhD

Contact Number:

212-342-5162

NCT Number:

NCT05083481

Population:

Adult

Phase:

I/II

The purpose of this study is to determine at what dose the study treatment (ASP1570) by itself or in combination with Pembrolizumab infusion therapy or standard therapies is safe and tolerated in study participants with locally advanced or metastatic solid tumors that cannot be removed or have spread (metastasized) to other parts of the body. The Food and Drug Administration (FDA) in the United States has not approved ASP1570 for the treatment of any form of cancer. This is a first in human study and all of the risks of the study drug are not fully known yet. Are you Eligible? (Inclusion...
A Phase 1 Study of ASP3082 in Participants with Previously Treated Locally Advanced or Metastatic Solid Tumor Malignancies with KRAS G12D Mutation

Principal Investigator:

Benjamin Herzberg, MD

Contact Number:

212-342-5162

NCT Number:

NCT05382559

Population:

Adult

Phase:

I

The purpose of this study is to find out if ASP3082 is effective and safe as a treatment in advanced cancers with KRAS G12D mutation. ASP3082 may work by directing proteins found in your body to block the growth of cancer cells. This is the first study where ASP3082 is being tested in humans. Are you Eligible? (Inclusion Criteria) Are you 18 years or older? Do you have locally advanced/unresectable or metastatic solid tumor with documented KRAS G12D mutation? Have you never been treated with another specific KRAS G12D inhibitor?
First-in-Human, Phase 1/1b, Open-label, Multicenter Study ofBifunctional EGFR/TGFβ Fusion Protein BCA101 Monotherapyand in Combination Therapy in Patients with EGFR-DrivenAdvanced Solid Tumors

Principal Investigator:

Catherine Shu, MD

Contact Number:

212-342-5162

NCT Number:

NCT04429542

Population:

Adult

Phase:

I

This is a first-in-human clinical research study. This study is sponsored by a biopharmaceutical company named Bicara Therapeutics. The main purpose of this study is to investigate the study drug BCA101 alone and BCA101 in combination with pembrolizumab for its safety, the way the body absorbs, distributes, and gets rid of this study drug, how the study drug acts on the body, and whether it works on your cancer in patients with advanced cancer like you. Subjects will receive either BCA101 alone or BCA101 in combination with pembrolizumab until disease worsens, the subject stops benefitting...
Phase 1, open label single-arm two-part study to investigate safety, pharmacokinetics, andpreliminary efficacy of pan-RAF/MEK glue NST-628 oral tablets in subjects with solid tumorsharboring genetic alterations in the MAPK pathway and with other solid

Principal Investigator:

Benjamin Herzberg, MD

Contact Number:

212-342-5162

NCT Number:

NCT06326411

Population:

Adult

Phase:

I

The purpose of this study is to find out if, and at what dose, NST-628 can safely treat solid cancers in patients who have no other treatment options left. NST-628 has been tested in animals and demonstrated some anti-tumor activity. This research study will be the first in which it will be given to humans and is experimental. “Experimental” means that the study drug has not been approved by any government authority responsible for the regulation of new medicines. This trial will explore what doses of NST-628 are safe and tolerable, as well as see whether NST-628 can slow the...

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