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Antibody Drug Conjugate

Cohort A monotherapy - HER2-low 2L or 3L breast cancer 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 5 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 5 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of participants with adverse events (AEs)

Number of participants with dose alterations

Number of participants with dose limiting toxicities DLTs) in dose escalation phase

+2 more

Secondary outcome measures

Disease control rate (DCR) per RECIST v1.1 by investigator assessment

Duration of response (DOR) per RECIST v1.1 by investigator assessment

Incidence of anti-drug antibodies (ADAs) against disitamab vedotin

+4 more

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

2018

Completed Phase 2

~800

0 / 15Eligibility criteria met

Find a Location

Who is running the clinical trial?

Seagen Inc.Lead Sponsor

208 Previous Clinical Trials

74,030 Total Patients Enrolled

6 Trials studying Breast Cancer

3,308 Patients Enrolled for Breast Cancer

RemeGen Co., Ltd.Industry Sponsor

74 Previous Clinical Trials

9,862 Total Patients Enrolled

3 Trials studying Breast Cancer

566 Patients Enrolled for Breast Cancer

Medical MonitorStudy DirectorSeagen Inc.

1,660 Previous Clinical Trials

983,631 Total Patients Enrolled

9 Trials studying Breast Cancer

699 Patients Enrolled for Breast Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment for this study currently open?

"The ongoing recruitment for participants in this study is documented on clinicaltrials.gov. The trial was first shared on 2/29/2024 and most recently revised on 2/7/2024."

Answered by AI

What is the current number of participants being enrolled in this research project?

"Affirmative. The details on clinicaltrials.gov indicate that this ongoing research study is actively seeking participants. It was first listed on February 29, 2024, and recently revised on February 7, 2024. A total of 198 individuals are sought for enrollment at a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "A Study of Disitamab Vedotin Alone or With Other Anticancer Drugs in Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06157892.

All > Metastatic Triple Negative Breast Cancer > Gastric Cancer