A Phase 1 Study of DB-1305 in People with Advanced Ovarian, Endometrial, Cervical, or Lung Cancers

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Full Title

A Phase 1/2a, Multicenter, Open-Label, First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1305 in Subjects with Advanced/Metastatic Solid Tumors

Purpose

The purpose of this study is to find the highest dose of the investigational drug DB-1305 that can be given safely in people with advanced ovarian, endometrial, cervical, or lung cancer that has come back or continued to grow despite treatment.

DB-1305 is an antibody-drug conjugate (ADC). It binds to a protein on cancer cells called Trop-2. It then releases an anti-cancer medication that enters cancer cells and causes them to die. DB-1305 is given intravenously (by vein).

Who Can Join

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have inoperable or metastatic ovarian, endometrial, cervical, or lung cancer that has come back or continued to grow despite treatment.
  • The serious side effects of previous therapies must go away before DB-1305 is given.
  • Patients must be physically well enough that they are able to be mobile, take care of themselves, and engage in all but physically strenuous activities. For example, they must be well enough that they could carry out office work or light housework.
  • This study is for people age 18 and older.

Contact

For more information and to ask about eligibility for this study, please contact the office of Dr. Maria Rubinstein at 646-888-6954.

Protocol

23-059

Phase

Phase I/II (phases 1 and 2 combined)

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT05438329