Study on Disitamab Vedotin Alone or With Other Cancer Drugs for Solid Tumors

Sponsor: Seagen Inc.

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06157892

Provider View

This clinical trial is testing a new drug, disitamab vedotin, alone or with another drug, tucatinib, to see if they are safe and effective for treating advanced breast or gastric cancers that have a specific marker called HER2.

Patient Parameters

Program Overview

This study focuses on advanced solid tumors, specifically breast and gastric cancers, that have a marker called HER2, which helps the cancer grow and spread. The trial is testing a new drug, disitamab vedotin, which is designed to attach to and kill cancer cells. It is also testing the combination of disitamab vedotin with another drug, tucatinib, which is already approved for cancer treatment. The study aims to find out how safe these drugs are and what side effects they might cause.

Description

This clinical trial is evaluating the use of disitamab vedotin, both alone and in combination with tucatinib, for patients with advanced breast or gastric cancer that have the HER2 marker. The study has two phases: a dose escalation phase to find the best dose of the drug combination, and a dose optimization phase to test the safety and effectiveness of the identified doses in patients with low HER2 levels. Once the best dose is determined, the combination therapy will be further tested in an expansion phase with two groups of patients: those with low HER2 gastric cancer and those with HER2 positive breast cancer.

Eligibility Criteria

Inclusion Criteria

  • Have a measurable tumor based on specific medical criteria.
  • Be in good overall health with a performance status score of 0 or 1.

For Dose Escalation Phase:

  • Have a confirmed diagnosis of gastric or breast cancer that is advanced or cannot be removed by surgery.
  • Have HER2 marker on the cancer cells.
  • Have tried standard treatments without success or cannot tolerate them.

For Cohort A (HER2-Low Breast Cancer):

  • Have a confirmed diagnosis of breast cancer that is advanced or cannot be removed by surgery.
  • Have low HER2 levels on the cancer cells.
  • Have tried up to 3 previous chemotherapy treatments.
  • If having a BRCA mutation, must have tried a PARP-inhibitor if available.
  • Have tried or cannot tolerate certain other cancer drugs.
  • If hormone receptor positive, must have tried hormone therapy and a CDK4/6 inhibitor.
  • If hormone receptor negative and PD-L1 positive, must have tried pembrolizumab with chemotherapy.

For Cohort B (HER2+ Breast Cancer):

  • Have a confirmed diagnosis of breast cancer that is advanced or cannot be removed by surgery.
  • Have high HER2 levels on the cancer cells.
  • Must have tried trastuzumab, pertuzumab, and a taxane if available.
  • Have tried or cannot tolerate certain other cancer drugs.
  • Have tried up to 3 previous chemotherapy treatments.

For Cohort C (HER2-Low Gastric Cancer):

  • Have a confirmed diagnosis of gastric cancer that is advanced or cannot be removed by surgery.
  • Have low HER2 levels on the cancer cells.
  • Must provide a tumor sample for testing.
  • Must have tried certain chemotherapy treatments.
  • Have tried or cannot tolerate certain other cancer drugs.
  • Must not have tried HER2 targeted therapy before.

Exclusion Criteria

  • Have an allergy to any ingredients in disitamab vedotin or tucatinib.
  • Have previously used ADCs with a specific payload or tucatinib.
  • Have active cancer spread to the brain or spinal fluid.
  • Have had cancer treatments within 4 weeks before starting the study.
  • Have had another invasive cancer within the last 3 years.
  • Cannot swallow pills or have a digestive issue that affects medication absorption.

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