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

Digestive System Diseases

Rare Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Uterine Cervical Neoplasms

Biliary Tract Neoplasms

Urologic Neoplasms

Uterine Neoplasms

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gastrointestinal Neoplasms

Digestive System Neoplasms

Biliary Tract Diseases

Gastrointestinal Diseases

Male Urogenital Diseases

Urologic Diseases

Biliary Tract Cancer

Hormones

Fulvestrant

Tucatinib

Antineoplastic Agents, Hormonal

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormone Antagonists

Protein Kinase Inhibitors

Enzyme Inhibitors

Tucatinib + trastuzumab (+ fulvestrant in hormone-receptor positive HER2-mutant breast cancer only)

tucatinib

Given into the vein (intravenously; IV). 8mg/kg IV on Cycle 1 Day 1, and 6mg/kg every 21 days starting on Cycle 2 Day 1

trastuzumab

Given into the muscle (intramuscular; IM) once every 4 weeks starting from Cycle 1 Day 1, plus one dose on Cycle 1 Day 15. Only administered to participants with hormone-receptor positive breast cancer.

fulvestrant

Jorge Ramos, DO

This trial studies how well tucatinib works for solid tumors that make either more HER2 or a different type of HER2 than usual (HER2 alterations) The solid tumors studied in this trial have either spread to other parts of the body (metastatic) or cannot be removed completely with surgery (unresectable).

All participants will get both tucatinib and trastuzumab. People with hormone-receptor positive breast cancer will also get a drug called fulvestrant.

The trial will also look at what side effects happen. A side effect is anything a drug does besides treating cancer.

There are multiple cohorts in this trial:

* 5 tumor specific cohorts with HER2 overexpression/amplification (cervical cancer, uterine cancer, biliary tract cancer, urothelial cancer, and non-squamous non-small cell lung cancer \[NSCLC\])
* 2 tumor specific cohorts with HER2 mutations (non-squamous NSCLC and breast cancer)
* 2 cohorts which will enroll all other HER2 amplified/overexpressed solid tumor types (except breast cancer, gastric or gastroesophageal junction adenocarcinoma \[GEC\], and colorectal cancer \[CRC\]) or HER2-mutated solid tumor types.

Basket Study of Tucatinib and Trastuzumab in Solid Tumors With HER2 Alterations

A Phase 2 Basket Study of Tucatinib in Combination With Trastuzumab in Subjects With Previously Treated, Locally Advanced Unresectable or Metastatic Solid Tumors Driven by HER2 Alterations

cORR is defined as the proportion of participants with best overall response of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

DCR is defined as the proportion of participants with confirmed CR, confirmed PR, or stable disease according to RECIST v1.1

DOR is defined as the time from first documentation of objective response of confirmed CR or confirmed PR to the first documentation of disease progression per RECIST v1.1 or death from any cause, whichever occurs first.

PFS is defined as the time from the date of treatment initiation to the date of disease progression according to RECIST v1.1 or death from any cause, whichever occurs first.

OS is defined as the time from treatment initiation to death due to any cause.

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.

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.
Basket Study of Tucatinib and Trastuzumab in Solid Tumors With HER2 Alterations	NCT04579380	Uterine Neoplas... Uterine Cervica... Biliary Tract N... Urologic Neopla... Carcinoma, Non-... HER2 Mutations ...	tucatinib trastuzumab fulvestrant	18 Years -	Seagen Inc.
Basket Study of Tucatinib and Trastuzumab in Solid Tumors With HER2 Alterations	NCT04579380	Uterine Neoplas... Uterine Cervica... Biliary Tract N... Urologic Neopla... Carcinoma, Non-... HER2 Mutations ...	tucatinib trastuzumab fulvestrant	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 mutations breast neoplasms