Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Triple Negative Breast Neoplasms

Breast Diseases

Skin Diseases

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Trastuzumab

Immunoglobulins

SGN-LIV1A

Antineoplastic Agents, Immunological

Immunoconjugates

Immunologic Factors

LV will be given at the recommended dose (at or below the monotherapy MTD determined in the LV dose escalation arm).

LV will be given into the vein (IV; intravenously)

ladiratuzumab vedotin

Trastuzumab will be given by IV every 3 weeks at a dose of 6 mg/kg (the first dose will be 8 mg/kg)

Brandon Croft, PharmD

Zejing Wang, MD, PhD

This study will examine the safety and tolerability of ladiratuzumab vedotin (LV) in patients with metastatic breast cancer. LV will be given alone or in combination with trastuzumab.

A Safety Study of SGN-LIV1A in Breast Cancer Patients

A Phase 1, Open-Label, Dose-Escalation Study to Evaluate the Safety and Tolerability of SGN-LIV1A in Patients With Metastatic Breast Cancer

An AE is any untoward medical occurrence in a patient or clinical investigational subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.

To be summarized using descriptive statistics.

ORR is defined as the proportion of patients with complete response (CR) or partial response (PR) per RECIST v1.1.

DOR is defined as the time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of tumor progression (clinical progression or progressive disease (PD) per RECIST v1.1).

PFS is defined as the time from start of study treatment to first documentation of tumor progression (clinical progression or PD per RECIST v1.1).

OS is defined as the time from start of study treatment to date of death due to any cause.

The PFS ratio is defined for each subject as the ratio of the current PFS and the PFS achieved on their most recent therapy where they experienced progression.

Seagen Inc.

Digestive System Diseases

Rare Diseases

Adenocarcinoma

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Disitamab vedotin

Tucatinib

Protein Kinase Inhibitors

Enzyme Inhibitors

disitamab vedotin

300mg given twice daily by mouth (orally)

tucatinib

Seagen Trial Information Support

Farshid Dayyani

Clinical Trial General Email

Jonathan King

Timothy J Pluard

Ashley Frith

Lee S Schwartzberg

Rosemarie Mestas

Sardar Z Imam

Sameh Mikhail

Melanie Hurst

Denise A Yardley

Medical Monitor

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 or without tucatinib, is 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.

This clinical trial is to evaluate disitamab vedotin alone and in combination with tucatinib in subjects with LA/metastatic breast cancer or gastric cancer/GEJC that express HER2. The study has a dose escalation phase evaluating disitamab vedotin plus tucatinib followed by a dose optimization phase. The 2 dose levels identified in the dose escalation phase will be assessed in the optimization phase for both safety and efficacy in HER2-low LA/mBC subjects. Once the safety and efficacy profile of disitamab vedotin plus tucatinib has been established and a disitamab vedotin dose with the optimum benefit/risk ratio has been determined the disitamab vedotin plus tucatinib combination therapy will be evaluated in an expansion phase with 2 expansion cohorts in subjects with HER2 low mGC/GEJC and HER2 + LA/mBC.

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

A Phase 1b/2 Open-Label Study of Disitamab Vedotin Monotherapy or in Combination With Other Anticancer Therapies in Solid Tumors

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

The proportion of participants with confirmed response (CR) or partial response (PR) according to RECIST v1.1.

The time from start of the first documentation of objective tumor response of CR or PR (that is subsequently confirmed) to the first documentation of progressive disease (PD) per RECIST v1.1, or to death due to any cause

The proportion of participants with stable disease (SD) or confirmed CR or PR according to RECIST v1.1.

The time from randomization (or Cycle 1 Day 1 for participants in dose escalation phase) to the first documentation of disease progression per RECIST v1.1 or death due to any cause.

The time from randomization (or Cycle 1 Day 1 for participants in dose escalation phase) to the date of death due to any cause.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Safety Study of SGN-LIV1A in Breast Cancer Patients	NCT01969643	HER2 Positive B... Hormone Recepto... Triple Negative... HER2 Mutations ...	ladiratuzumab v... Trastuzumab	18 Years -	Seagen Inc.
A Study of Disitamab Vedotin Alone or With Other Anticancer Drugs in Solid Tumors	NCT06157892	Breast Neoplasm... Gastroesophagea... HER2 Low Breast... HER2 Positive B... Stomach Neoplas... Triple Negative...	disitamab vedot... tucatinib	18 Years -	Seagen Inc.
A Safety Study of SGN-LIV1A in Breast Cancer Patients	NCT01969643	HER2 Positive B... Hormone Recepto... Triple Negative... HER2 Mutations ...	ladiratuzumab v... Trastuzumab	18 Years -	Seagen Inc.

Spots Global Cancer Trial Database for her2 positive breast neoplasms