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Antibody Drug Conjugate

Disitamab Vedotin + Tucatinib for Breast Cancer

Phase 1 & 2
Recruiting
Research Sponsored by Seagen Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Locally-advanced, unresectable, or metastatic stage
No more than 3 prior systemic cytotoxic chemotherapy regimens (including ADCs) for LA/mBC
Must not have
Prior therapy with tucatinib
Active CNS and/or leptomeningeal metastasis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new drug called disitamab vedotin (DV) in combination with a drug called tucatinib for patients with advanced or metastatic solid tumors that express HER

Who is the study for?
This trial is for adults with advanced breast or gastric cancer that has HER2 proteins, which can make the cancer grow faster. Participants must have a certain level of health and fitness (ECOG score 0-1) and measurable disease according to specific criteria. They should have tried standard treatments without success or be unable to tolerate them.
What is being tested?
The study is testing disitamab vedotin (DV), an experimental drug designed to target and kill cancer cells, alone or combined with tucatinib, a drug approved in the US for treating cancer. The goal is to see how safe these drugs are for patients with solid tumors expressing HER2 and what side effects they may cause.
What are the potential side effects?
Possible side effects from DV and tucatinib include reactions at the infusion site, fatigue, nausea, diarrhea, liver issues, low blood cell counts leading to increased infection risk or bleeding problems. Each patient's experience with side effects may vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is advanced and cannot be removed by surgery.
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I have had 3 or fewer chemotherapy treatments for my advanced breast cancer.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My cancer progressed after or didn't tolerate certain therapies.
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My cancer progressed after treatment with T-DXd or I couldn't tolerate it.
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My cancer is confirmed as stomach, gastroesophageal junction, or breast cancer.
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I have never had treatment targeting HER2 for my cancer.
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My HR+ tumor does not respond to hormone therapy anymore.
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I have a BRCA mutation and have taken a PARP-inhibitor if it was available and safe for me.
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My cancer is HR-, HER2-low, and PD-L1+ (CPS 10+) and I've had pembrolizumab with chemotherapy if it was the standard care.
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My condition worsened after standard treatments or I couldn't tolerate them.
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I have had 2 or fewer chemotherapy treatments for my advanced stomach cancer.
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My cancer has a HER2 status of 1+ or higher.
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I have had treatments with platinum, fluorouracil, or taxane for advanced cancer that cannot be surgically removed.
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I have been treated with trastuzumab, pertuzumab, and a taxane if they were recommended.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been treated with tucatinib before.
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My cancer has spread to my brain or its coverings.
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I haven't had any other cancer besides this one in the last 3 years.
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I cannot swallow pills or have a GI condition that affects medication absorption.
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I have been treated with ADCs that contain MMAE before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of participants with adverse events (AEs)
Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by investigator assessment
Secondary study objectives
Disease control rate (DCR) per RECIST v1.1 by investigator assessment
Duration of response (DOR) per RECIST v1.1 by investigator assessment
Overall survival (OS)
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

7Treatment groups
Experimental Treatment
Group I: Dose Escalation - Previously treated advanced GC/GEJC or breast cancerExperimental Treatment2 Interventions
disitamab vedotin + tucatinib
Group II: Cohort C monotherapy - HER2-low 2L GC/GEJCExperimental Treatment1 Intervention
disitamab vedotin monotherapy
Group III: Cohort C - HER2-low 2L GC/GEJCExperimental Treatment2 Interventions
disitamab vedotin + tucatinib
Group IV: Cohort B monotherapy - HER2+ 3L or higher breast cancerExperimental Treatment1 Intervention
disitamab vedotin monotherapy
Group V: Cohort B - HER2+ 3L or higher breast cancerExperimental Treatment2 Interventions
disitamab vedotin + tucatinib
Group VI: Cohort A monotherapy - HER2-low 2L or 3L breast cancerExperimental Treatment1 Intervention
disitamab vedotin monotherapy
Group VII: Cohort A - HER2-low 2L or 3L breast cancerExperimental Treatment2 Interventions
disitamab vedotin + tucatinib
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
tucatinib
2021
Completed Phase 3
~810

Find a Location

Who is running the clinical trial?

Seagen Inc.Lead Sponsor
210 Previous Clinical Trials
74,232 Total Patients Enrolled
5 Trials studying Breast Cancer
3,066 Patients Enrolled for Breast Cancer
RemeGen Co., Ltd.Industry Sponsor
82 Previous Clinical Trials
10,869 Total Patients Enrolled
5 Trials studying Breast Cancer
685 Patients Enrolled for Breast Cancer
Medical MonitorStudy DirectorSeagen Inc.
1,675 Previous Clinical Trials
988,600 Total Patients Enrolled
9 Trials studying Breast Cancer
699 Patients Enrolled for Breast Cancer
~132 spots leftby Jan 2030
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