Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Digestive System Diseases

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Adenocarcinoma

Stomach Neoplasms

Breast Neoplasms

Colorectal Neoplasms

Esophageal Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Uterine Cervical Neoplasms

Endometrial Neoplasms

Pseudomyxoma Peritonei

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Breast Diseases

Skin Diseases

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

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

Stomach Diseases

Head and Neck Neoplasms

Esophageal Diseases

Uterine Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Adenocarcinoma, Mucinous

Neoplasms, Cystic, Mucinous, and Serous

Stomach Cancer

Esophageal Cancer

Ovarian Cancer

Ovarian Epithelial Cancer

Adenocarcinoma of the Appendix

SGN-STNV

Suzanne McGoldrick, MD

This trial will look at a drug called SGN-STNV to find out whether it is safe for patients with solid tumors. It will study SGN-STNV to find out what its side effects are. A side effect is anything the drug does besides treating cancer. It will also study how well SGN-STNV works to treat solid tumors.

The study will have two parts. Part A of the study will find out how much SGN-STNV should be given to patients. Part B will use the dose found in Part A to find out how safe SGN-STNV is and if it works to treat certain types of solid tumors.

The study will include dose escalation (Part A) and dose expansion (Part B), with multiple disease-specific cohorts and a biology cohort in dose expansion. The biology cohort will require additional biopsies. At the completion of dose escalation, up to 5 disease specific expansion cohorts and 1 biology expansion cohort may be activated by the sponsor in consultation with the Safety Monitoring Committee (SMC). Expansion cohorts in Part B will enroll subjects with selected tumors that are eligible for enrollment in Part A. The dose(s) to be examined in Part B will be at or below the maximum tolerated dose and/or the recommended dose determined in Part A. The recommended dose and/or schedule may differ between cohorts.

A Study of SGN-STNV in Advanced Solid Tumors

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

To be summarized using descriptive statistics

ORR is defined as the proportion of subjects achieving a partial response (PR) or complete response (CR).

PFS is defined as the time from the start of any study treatment to first documentation of disease progression or to death due to any cause, whichever comes first.

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

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 or to death due to any cause, whichever comes first.

Seagen Inc.

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Urinary Bladder Neoplasms

Esophageal Squamous Cell Carcinoma

Neoplasms, Squamous Cell

Urologic Neoplasms

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Carboplatin

Cisplatin

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

sigvotatug vedotin + pembrolizumab +/- (carboplatin or cisplatin)

sigvotatug vedotin + pembrolizumab +/- (carboplatin)

Administered into the vein (IV; intravenously)

sigvotatug vedotin

200mg every 3 weeks or 400mg every 6 weeks, given by IV

pembrolizumab

cisplatin

AUC 5 mg/mL per min every 3 weeks, given by IV

carboplatin

Seagen Trial Information Support

Ingrid Acker

Cesar Perez Batista, MD

Alisa Posner

Bruno Bockorny, MD

Illya Dixon

Kartik Sehgal

Edwin C Kingsley

Megan Boland

Afshin Dowlati

Providence Cancer Institute CT.Gov Contact

Rachel E Sanborn

Staci Vogel

Steven Powell

Rabia Khan

Sarina A Piha-Paul

Isabel Jimenez

Amita Patnaik

Yiqun (Lydia) Xue

Joseph Z Ye

Antoine Hollebecque

Tatiana Carolina Hernandez Guerrero

Elena Garralda Cabanas

Alvaro Rodriguez Lescure

Jesus Corral

Federico Longo

Emiliano Calvo

Fernando Rivera Herrero

Solange Peters

Elisa Fontana

Juanita Lopez

Medical Monitor

This trial will look at a drug called sigvotatug vedotin (SGN-B6A) alone and with pembrolizumab, with or without chemotherapy, to find out whether it is safe for people who have solid tumors. It will study sigvotatug vedotin to find out what its side effects are. A side effect is anything the drug does besides treating cancer. It will also study whether sigvotatug vedotin works to treat solid tumors.

The study will have four parts.

* Part A of the study will find out how much sigvotatug vedotin should be given to participants.
* Part B will use the dose found in Part A to find out how safe sigvotatug vedotin is and if it works to treat solid tumors.
* Part C of the study will find out how safe sigvotatug vedotin is in combination with these other drugs.
* Part D will include people who have not received treatment. This part of the study will find out how safe sigvotatug vedotin is in combination with these other drugs and if these combinations work to treat solid tumors.
* In Parts C and D, participants will receive sigvotatug vedotin with either:

  * Pembrolizumab or,
  * Pembrolizumab and carboplatin, or
  * Pembrolizumab and cisplatin.

A Study of SGN-B6A in Advanced Solid Tumors

A Phase 1 Study of SGN-B6A 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 RECIST v1.1.

The time from the first documentation of objective response (CR or PR that is subsequently confirmed) to the first documentation of progressive disease (PD) or to death due to any cause

The time from the start of any study treatment to the first documentation of PD, or 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	Link
A Study of SGN-STNV in Advanced Solid Tumors	NCT04665921	Carcinoma, Non-... HER2 Negative B... Ovarian Neoplas... Uterine Cervica... Endometrial Neo... Esophageal Neop... Gastroesophagea... Stomach Neoplas... Colorectal Neop... Exocrine Pancre... Appendiceal Ade... Pseudomyxoma Pe...	SGN-STNV	18 Years -	Seagen Inc.
A Study of SGN-B6A in Advanced Solid Tumors	NCT04389632	Carcinoma, Non-... Squamous Cell C... HER2 Negative B... Esophageal Squa... Esophageal Aden... Gastroesophagea... Ovarian Neoplas... Cutaneous Squam... Exocrine Pancre... Urinary Bladder... Uterine Cervica... Stomach Neoplas...	sigvotatug vedo... pembrolizumab cisplatin carboplatin	18 Years -	Seagen Inc.

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