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An open-label, multi-center phase I/Ib dose finding and expansion study of HRO761 as single agent and in combinations in patients with Microsatellite Instability-High or Mismatch Repair Deficient advanced solid tumors

Principal Investigator:

Edmond M. Chan, MD

Contact Number:

212-342-5162

NCT Number:

NCT05838768

Population:

Adult

Phase:

I

The main purpose of the study is to find the optimal dose of HRO761 alone or in combination with tislelizumab or irinotecan that can be given to people with certain cancer types called MSI high or dMMR. The new drug being tested in the study, HRO761, is an oral drug that is called a “targeted medicine”: this means that it targets particular processes which may not be working properly in the cancer cells in a participant's body and causing their disease. This is the first time HRO761 is given to people and the first time HRO761 is used in combination with tislelizumab or irinotecan...
A Phase I/2a, Multicenter, Open-Label, First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti tumor Activity of DB-1311 in Subjects with Advanced/Metastatic Solid Tumors

Principal Investigator:

Brian Henick, MD

Contact Number:

212-342-5162

NCT Number:

NCT05914116

Population:

Adult

Phase:

I/II

DB-1311 (study drug) is an investigational antibody-drug conjugate (antibody that guides the study drug to cancer cells) composed of an anti-B7-H3 (a protein associated with worse overall survival and drug resistance) antibody and P1021 (slows DNA replication in cancer cells). Investigational means the study drug being tested is not approved by the United States (U.S.) Food and Drug Administration (FDA). The main goal of this study is to test whether the study drug is safe and tolerable in patients with certain types of cancer. This study will also measure the amount of the study drug in...
A Phase 1/2 Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of BLU-222 as a Single Agent and in Combination Therapy for Patients with Advanced Solid Tumors

Principal Investigator:

Julia E McGuinness, MD

Contact Number:

212-342-5162

NCT Number:

NCT05252416

Population:

Adult

Phase:

I/II

This first-in-human study will evaluate the recommended dose, safety, and effects (good and bad) of an experimental drug, BLU-222, either alone or in combination with therapies approved for some types of cancer, including carboplatin, ribociclib, and fulvestrant, to find out if these are safe and effective ways to treat nonresectable (unable to be removed with surgery) advanced solid tumors, including ovarian, endometrial, and estrogen receptor positive (ER+) or human epidermal growth factor receptor 2 negative (HER2-) breast cancer. All subjects participating in this research study will...
A Phase 1/2, Open-label Study to Investigate the Safety, Tolerability, Pharmacokinetics, andPreliminary Antitumor Activity of NDI-101150 Administered as Monotherapy or in Combination withPembrolizumab in Patients with Solid Tumors

Principal Investigator:

Ryan H. Moy, MD, PhD

Contact Number:

212-342-5162

NCT Number:

NCT05128487

Population:

Adult

Phase:

I/II

The purpose of this study is to find out if a new investigational drug NDI-101150 is safe when given alone and in combination with pembrolizumab, and to look at the pharmacokinetics (PK, to measure how your body takes up, breaks down, and clears NDI- 101150) and the antitumor activity (to measure how NDI-101150 works in your tumors). Investigational means the drug has not been approved by the Food and Drug Administration (FDA). This is the first time that NDI-101150 is being tested in humans. NDI-101150 is a small molecule inhibitor of HPK1 (a protein that weakens the immune system). It is...
Phase 1/2, First-in-Human, Open-Label, Dose-Escalation Study of TAK-186 (also known as MVC-101), An EGFR x CD3 COnditional Bispecific Redirected Activation (COBRA) Protein in Patients with Unresectable Locally Advanced or Metastatic Cancer CP-MVC-101-01

Principal Investigator:

Ryan H. Moy, MD, PhD

Contact Number:

212-342-5162

NCT Number:

NCT04844073

Population:

Adult

Phase:

I/II

The purpose of this study is to determine the safety (how many side effects you and other patients have) and tolerability (how tolerable the side effects are) of a study drug called TAK186, and what is the highest and safest dose of TAK-186 that should be used for cancer patients. TAK-186 is a kind of antibody (a special kind of protein) being developed for the treatment of cancer. It is thought to work by attaching to both cancer cells and certain types of immune cells (T-cells) at the same time. TAK-186 is designed to activate T-cells to work against the cancer, helping the body’s...
A Phase 1/2 Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, andEfficacy of AMG 193 in Combination With IDE397 in Subjects With Advanced MTAP-null SolidTumors

Principal Investigator:

Benjamin Herzberg, MD

Contact Number:

212-342-5162

NCT Number:

NCT05975073

Population:

Adult

Phase:

I/II

The purpose of this study is to assess how the study drugs, AMG 193 and IDE397, move throughout the body, how the study drugs work in the body, whether they are safe, and an effective treatment option for people with advanced solid tumors lacking methylthioadeosine phosphorylase (MTAP) in the DNA (genetic material). Lacking MTAP may limit the way in which the enzyme, protein arginine methyltransferase 5 (PRMT5) works. PRMT5 is important for cancer cell survival and works with an enzyme methionine adenosyltransferase 2A (MAT2A). AMG193 may further slow down PRMT5 activity and kill cancer cells...
A Study of PARG Inhibitor IDE161 in Participants with Advanced Solid Tumors

Principal Investigator:

Benjamin Herzberg, MD

Contact Number:

212-342-5162

NCT Number:

NCT05787587

Population:

Adult

Phase:

I

The purpose of this study is to find out if the experimental study drug called IDE161 used alone is safe and helpful in solid tumors known to be caused by an error in genes that repair DNA. Cells have different ways to repair damaged DNA. Experimental means that the study drug has not been approved by any regulatory authorities, including the U.S. Food and Drug Administration (FDA) .IDE161 may block the ability of a protein called Poly(ADP-ribose) glycohydrolase (PARG) from properly functioning. PARG is an important protein in a different DNA repair pathway called Base Excision Repair (BER)...
Phase 1 Trial of the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Clinical Activity of RP-1664 in Participants with Advanced Solid Tumors

Principal Investigator:

Benjamin Herzberg, MD

Contact Number:

212-342-5162

NCT Number:

NCT06232408

Population:

Adult

Phase:

I

The purpose of this study is to learn how well RP-1664 alone works to treat advanced solid tumor. RP-1664 has not been approved by the Food and Drug Administration (FDA). RP- 1664 has not been given to humans prior to this study. Are you Eligible? (Inclusion Criteria) Must be 18 years old or older - Able to swallow and retail oral medications - Ability to consume a high-fat meal and fast for 12 hours
A PHASE 1/2, OPEN-LABEL, MULTICENTER STUDY OF ORAL MRT-2359 IN PATIENTS WITH MYC-DRIVEN AND OTHER SELECTED SOLID TUMORS INCLUDING LUNG CANCER AND DIFFUSE LARGE B-CELL LYMPHOMA

Principal Investigator:

Benjamin Herzberg, MD

Contact Number:

212-342-5162

NCT Number:

NCT05546268

Population:

Adult

Phase:

I/II

The purpose of this study is to evaluate the safety and confirm the best dose in humans for an investigational drug called MRT-2359 in subjects with solid tumors and diffuse large B-cell lymphoma. “Investigational” means the study drug has not been approved for the treatment of participants with cancer by the Food and Drug Administration (“FDA”) or any other health/regulatory authority anywhere in the world.MRT-2359 is called a molecular glue degrader or MGD. This MGD can selectively stick to a protein called G1 To S Phase Transition 1 (GSPT1) and cause GSPT1 to...
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...

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