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.

Respiratory Tract (Lung and Bronchial) Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Digestive System Diseases

Rare Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Cholangiocarcinoma

Endometrial Neoplasms

Fallopian Tube Neoplasms

Peritoneal Neoplasms

Carcinoma, Adenoid Cystic

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Uterine Neoplasms

Uterine Diseases

Abdominal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Peritoneal Diseases

Fallopian Tube Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Bile Duct Cancer

Gallbladder Cancer

Fallopian Tube Cancer

Adenoid Cystic Carcinoma

SGN-B7H4V

Seagen Trial Information Support

Brandi Asheim

Jennifer Diamond

Jason Henry

Charmaine Garcia

Guru Sonpavde

Ivy Vilches

Gerardo Colon-Otero

Cesar Perez Batista, MD

Northwestern University CT.Gov Contact

Aparna Kalyan, MBBS

Adam Byers

Bert H O'Neil

Shannon Fabrie

Nehal Lakhani, MD, PhD

Melanie Hurst

Erika P Hamilton

Amanda Drews

Renata Ferrarotto

Isabel Jimenez

Amita Patnaik

Casey Larsen

Justin Call

Arif Awan

Antonia Busse

Giuseppe Curigliano

Elena Garralda Cabanas

Irene Moreno Candilejo

Elisa Fontana

Medical Monitor

This study will test the safety of a drug called SGN-B7H4V in participants with solid tumors. It will also study the side effects of this drug. A side effect is anything a drug does to the body besides treating the disease.

Participants will have cancer that has spread in the body near where it started (locally advanced) and cannot be removed (unresectable) or has spread through the body (metastatic).

This study will have three parts. Parts A and B of the study will find out how much SGN-B7H4V should be given to participants. Part C will use the dose found in Parts A and B to find out how safe SGN-B7H4V is and if it works to treat solid tumor cancers.

A Study of SGN-B7H4V in Advanced Solid Tumors

A Phase 1 Study of SGN-B7H4V in Advanced Solid Tumors

Any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment.

The proportion of participants with complete response (CR) or partial response (PR) which is subsequently confirmed as assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by investigator.

The proportion of participants achieving a CR as determined by the investigator per RECIST Version 1.1.

The time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of tumor progression or to death due to any cause.

The time from the start of any study treatment to first documentation of disease progression or to death due to any cause.

The time from the start of any study treatment 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 SGN-B7H4V in Advanced Solid Tumors	NCT05194072	Ovarian Neoplas... Peritoneal Neop... Fallopian Tube ... Triple Negative... HER2 Negative B... Hormone Recepto... Endometrial Neo... Carcinoma, Non-... Cholangiocarcin... Gallbladder Car... Adenoid Cystic ...	SGN-B7H4V	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.
A Study of SGN-B7H4V in Advanced Solid Tumors	NCT05194072	Ovarian Neoplas... Peritoneal Neop... Fallopian Tube ... Triple Negative... HER2 Negative B... Hormone Recepto... Endometrial Neo... Carcinoma, Non-... Cholangiocarcin... Gallbladder Car... Adenoid Cystic ...	SGN-B7H4V	18 Years -	Seagen Inc.

Spots Global Cancer Trial Database for hormone receptor positive breast neoplasms