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A Study of Disitamab Vedotin With Other Anticancer Drugs in Solid Tumors

NCT06157892 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 172

Last updated 2026-05-05

No results posted yet for this study

Summary

This clinical trial is studying solid tumor cancers. A solid tumor is one that starts in part of your body like your lungs or liver instead of your blood. Once they've grown bigger in one spot or spread to other parts of the body, they're harder to treat. This is called advanced or metastatic cancer.

Participants in this study must have breast cancer or gastric cancer. Participants must have tumors that have HER2 on them. This allows the cancer to grow more quickly or spread faster. There are few treatment options for patients with advanced or metastatic solid tumors that express HER2.

This clinical trial uses an experimental drug called disitamab vedotin (DV). Disitamab vedotin is a type of antibody drug conjugate or ADC. ADCs are designed to stick to cancer cells and kill them.

This clinical trial uses a drug called tucatinib, which has been approved to treat cancer in the United States and some other countries. This drug is sold under the brand name TUKYSA®.

This study will test how safe and how well DV with tucatinib works for participants with solid tumors. This study will also test what side effects happen when participants take these drugs. A side effect is anything a drug does to the body besides treating the disease.

Conditions

  • Breast Neoplasms
  • Gastroesophageal Junction Adenocarcinoma
  • HER2 Low Breast Neoplasms
  • HER2 Positive Breast Neoplasms
  • Stomach Neoplasms
  • Triple Negative Breast Neoplasms
  • Metastatic Breast Cancer
  • Metastatic Gastric Cancer
  • Advanced Breast Cancer
  • Advanced Gastric Cancer

Interventions

DRUG

disitamab vedotin

Given into the vein (IV; intravenous)

DRUG

tucatinib

300mg given twice daily by mouth (orally)

Sponsors & Collaborators

  • RemeGen Co., Ltd.

    collaborator INDUSTRY

  • Seagen, a wholly owned subsidiary of Pfizer

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-20
Primary Completion
2029-07-28
Completion
2029-07-28
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Germany
  • Italy
  • Japan
  • South Korea
  • Spain
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06157892 on ClinicalTrials.gov