A Phase 1 Study of PRT3789 in People With Solid Tumors

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Full Title

A Phase 1 Open-Label, Multi-Center, Safety and Efficacy Study of PRT3789 as Monotherapy and in Combination with Docetaxel in Participants with Advanced or Metastatic Solid Tumors with a SMARCA4 Mutation

Purpose

Researchers are seeking the highest dose of the drug PRT3789 that they can use safely to treat advanced cancers. The people in this study will have cancer that has spread to other parts of the body despite prior treatment. In addition, participants’ cancers must have an abnormal form of a gene called SMARCA4.

Solid tumors with SMARCA4 that doesn’t work well depend more on another gene called SMARCA2. PRT3789 is designed to target SMARCA2. When this happens, cancer cells with abnormal SMARCA4 cannot use SMARCA2, which may slow or stop cancer growth. PRT3789 is given intravenously (by vein).

Who Can Join

To take part in this study, patients must meet several requirements, including:

  • Participants must have a solid tumor cancer that continues to grow despite prior treatment. The cancer must have spread (metastasized) or be inoperable (unable to be removed with surgery).
  • Patients must have a SMARCA4 gene mutation that causes a loss of function.
  • Previous treatment must stop before the study therapy is given.
  • Patients must be physically well enough that they can be mobile, take care of themselves, and engage in all but physically strenuous activities. For example, they must be well enough that they could do office work or light housework.
  • This study is for people age 18 and older.

Contact

For more information and to see if you may be able to be in this study, please contact the office of Dr. Robin Guo at 646-888-6950.

Protocol

23-090

Phase

Phase I (phase 1)

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators

Diseases

ClinicalTrials.gov ID

NCT05639751