First-in-Human Study of DS-3939a for Patients with Advanced Solid Tumors

Sponsor: Daiichi Sankyo

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05875168

Provider View

This clinical trial is testing a new drug, DS-3939a, to see if it is safe and effective for treating advanced solid tumors. The study is divided into two parts to find the best dose and to see how well the drug works.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety, tolerability, and effectiveness of a new drug called DS-3939a in patients with advanced solid tumors. DS-3939a is a type of treatment known as an antibody drug conjugate (ADC), which is being tested for the first time in humans. The study is divided into two parts: the first part focuses on finding the right dose, and the second part looks at how well the drug works in a larger group of patients.

Description

DS-3939a is a new type of cancer treatment called an antibody drug conjugate (ADC), which is being tested for the first time in humans. This study is divided into two parts:

  • Part 1: Dose Escalation - This part of the study aims to find the safest and most effective dose of DS-3939a by gradually increasing the dose given to participants.
  • Part 2: Dose Expansion - Once the best dose is found, this part will test how well DS-3939a works in a larger group of patients with specific types of advanced cancers.

Participants will receive DS-3939a and will be monitored closely to assess the drug's safety and its effects on their cancer.

Eligibility Criteria

Inclusion Criteria

  • Must sign and date the informed consent form.
  • Have a heart function of 50% or higher, as measured by specific heart tests.
  • Have good organ function.
  • Have measurable cancer based on standard criteria.
  • Be in good overall health, with a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.

Additional criteria for Part 1:

  • Have advanced, metastatic, or inoperable cancer of the bladder, lung, breast, ovary, bile duct, or pancreas, regardless of specific cancer subtypes.

Additional criteria for Part 2:

  • Have advanced, metastatic, or inoperable cancer that has progressed during or after the most recent treatment.
  • Be able to provide a tumor sample from a recent biopsy or surgery.

Exclusion Criteria

  • Have had previous treatment targeting specific proteins called MUC1 or TA-MUC1.
  • Have spinal cord compression or active cancer spread to the brain.
  • Have multiple types of cancer, except for certain skin cancers or other cancers that have been treated and have shown no signs of disease for 3 years or more.
  • Have a history of lung diseases like interstitial lung disease or pneumonitis, or current lung issues that cannot be ruled out by imaging.
  • Have active HIV infection.
  • Have active hepatitis B or C infection.
  • Have had a stroke, mini-stroke, or other serious blood vessel issues in the past 6 months.
  • Have an active autoimmune disease.
  • Be participating in other experimental treatments, except for long-term follow-up without active treatment.

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