Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

172

participants targeted

Target at P75+ for phase_2

Timeline

39mo left

Started May 2024

Longer than P75 for phase_2

Geographic Reach

10 countries

141 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

5.2 years study duration

Study Progress38%

May 2024Jul 2029

First Submitted

Initial submission to the registry

November 27, 2023

Completed

9 days until next milestone

First Posted

Study publicly available on registry

December 6, 2023

Completed

6 months until next milestone

Study Start

First participant enrolled

May 20, 2024

Completed

5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 28, 2029

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 28, 2029

Last Updated

May 5, 2026

Status Verified

May 1, 2026

Enrollment Period

5.2 years

First QC Date

November 27, 2023

Last Update Submit

May 4, 2026

Conditions

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

Keywords

Breast CancerGastric CancerGCGEJHER2-Low Breast CancerHER2-Positive Breast CancerSeattle Genetics

Outcome Measures

Primary Outcomes (5)

Number of participants with dose limiting toxicities (DLTs) in dose escalation phase
Up to 28 days
Number of participants with adverse events (AEs)
Any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention
Through 30 days after the last study treatment; approximately 5 years
Number of participants with laboratory abnormalities
Through 30-37 days after the last study treatment: approximately 5 years
Number of participants with dose alterations
Through 30-37 days after the last study treatment: approximately 5 years
Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by investigator assessment
The proportion of participants with confirmed response (CR) or partial response (PR) according to RECIST v1.1.
Approximately 3 years

Secondary Outcomes (7)

Duration of response (DOR) per RECIST v1.1 by investigator assessment
Approximately 5 years
Disease control rate (DCR) per RECIST v1.1 by investigator assessment
Approximately 5 years
Progression free survival (PFS) per RECIST v1.1 by investigator assessment
Approximately 5 years
Overall survival (OS)
Approximately 5 years
Pharmacokinetic (PK) parameter - Maximum concentration (Cmax)
Through 30-37 days after the last study treatment; approximately 5 years
+2 more secondary outcomes