Personalized Antibody-Drug Conjugate Therapy for Advanced or Metastatic Solid Tumors Based on RNA and Protein Testing

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0

ClinicalTrials ID:NCT06311214

Provider View

This clinical trial is exploring a personalized treatment approach using antibody-drug conjugates (ADCs) for patients with advanced or metastatic solid tumors. The study focuses on tumors with high levels of specific proteins, using precision medicine to tailor treatment to each patient's unique cancer profile.

Patient Parameters

Program Overview

The study aims to determine if personalized treatments using ADCs—sacituzumab govitecan, enfortumab vedotin, and trastuzumab deruxtecan—can effectively treat advanced or metastatic solid tumors. These ADCs target specific proteins (Trop-2, nectin-4, or HER2) on cancer cells, delivering drugs directly to the tumor. This approach is part of precision medicine, which customizes treatment based on a person's genes and proteins. The trial will assess if these targeted therapies can help control cancer that has spread from its original site.

Description

The trial is divided into several parts:

Screening:

  • Patients will undergo RNA testing to identify high levels of specific proteins (Trop-2, nectin-4, or HER2) in their tumors.
  • If high protein levels are confirmed, patients will be assigned to one of three treatment groups based on their protein type.

Treatment Groups:

  • Cohort A: Patients with high Trop-2 protein receive sacituzumab govitecan through an IV on specific days of a 21-day cycle.
  • Cohort B: Patients with high nectin-4 protein receive enfortumab vedotin through an IV on specific days of a 28-day cycle.
  • Cohort C: Patients with high HER2 protein receive trastuzumab deruxtecan through an IV on specific days of a 21-day cycle.

Throughout the trial, patients will have regular scans (CT or MRI) and may undergo biopsies and blood tests to monitor their response to treatment. If a specific tumor type responds well, additional patients with that tumor type may be included in the study.

After completing the treatment, patients will have follow-up visits to monitor their health and any changes in their cancer.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of a solid tumor that requires treatment.
  • Cancer must not be treatable with curative intent or must have progressed after all available treatments.
  • Must have undergone RNA testing to identify high levels of specific proteins (Trop-2, nectin-4, or HER2).
  • Must be willing to undergo mandatory biopsies before and during treatment.
  • Must be 18 years or older.
  • Must have a good performance status and no history of transfusion dependence.
  • Must have adequate organ function and blood counts.
  • Must not have active infections like HIV or hepatitis unless well-controlled.
  • Women of childbearing potential must have a negative pregnancy test and agree to use contraception during the study and for a period after.
  • Must be able to understand and sign a consent form.

Exclusion Criteria

  • Active or untreated brain metastases or leptomeningeal disease.
  • Significant heart conditions or abnormal heart rhythms.
  • Active or chronic eye disorders requiring treatment.
  • History of severe allergic reactions to similar drugs.
  • History of lung disease requiring steroids.
  • Pregnant or breastfeeding women.
  • Recent use of certain medications or treatments that could interfere with the study.
  • Uncontrolled infections or other serious medical conditions that could affect participation.
  • Specific exclusions for each treatment group based on prior treatments or other health conditions.

Locations

FACILITYZIPCITYSTATE
University of Texas MD Anderson Cancer Center LAO77030HoustonTexas

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