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

NOT ENROLLING
Protocol # :
21-001
Conditions
Carcinoma, Non-Small Cell Lung
HER2 Negative Breast Neoplasms
Ovarian Neoplasms
Uterine Cervical Neoplasms
Endometrial Neoplasms
Esophageal Neoplasms
Gastroesophageal Junction Carcinoma
Stomach Neoplasms
Colorectal Neoplasms
Exocrine Pancreatic Adenocarcinoma
Appendiceal Adenocarcinoma
Pseudomyxoma Peritonei
Phase
I
Disease Sites
Healthy volunteer
Transplanted organ and tissue status, unspecified
Disease not specified
Neuroendocrine/Carcinoid
Gastroesophageal Junction
Gallbladder/Biliary
Other specified personal risk factors, not elsewhere classified
Lip, Oral Cavity and Pharynx
Esophagus
Stomach
Small Intestine
Colon
Rectum
Anus
Liver
Pancreas
Other Digestive Organ
Larynx
Lung
Other Respiratory and Intrathoracic Organs
Bones and Joints
Soft Tissue
Mycosis Fungoides
Other Skin
Breast
Cervix
Corpus Uteri
Ovary
Other Female Genital
Prostate
Other Male Genital
Urinary Bladder
Kidney
Other Urinary
Eye and Orbit
Brain and Nervous System
Thyroid
Unknown Sites
Ill-Defined Sites
Other Endocrine System
Donors
Kaposi's Sarcoma
Melanoma, Skin
Principal Investigator
Lee, Elizabeth
Site Research Nurses
Baylies, Rosemarie
Carey, Margaret, M.
Combs, Sarah
Gillen Mckay, Christine, A.
Gotthardt, Susan, Jean
Grimes, Hayley
Hart, Kayla
Hedglin, Jennifer
Mackoul, Anna
Maurer, Kimberly
Nicolazzo, Karicaty
O’Neill, Kailene
QUINN, NICHOLAS
Sidoti, Emma, Grace
Treveloni, Emily

Trial Description

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.

Eligibility Requirements

Inclusion Criteria:

- Disease indication

- Must have disease that is relapsed or refractory or be intolerant to
standard-of-care therapies and should have no appropriate standard-of-care
therapeutic option.

- Non-small cell lung cancer (NSCLC)

- HER2 negative breast cancer

- Ovarian cancer

- Cervical cancer

- Endometrial cancer

- Esophageal cancer

- Gastric cancer and GEJ carcinoma

- Colorectal cancer

- Exocrine pancreatic adenocarcinoma

- Appendiceal adenocarcinoma and pseudomyxoma peritonei of unknown origin

- Participants enrolled in the following study parts should have an appropriate tumor
site that satisfies the following criteria:

- Site has tumor that is not a target lesion and has not been previously irradiated
(unless progression has occurred since end of radiotherapy)

- Site has tumor that is accessible for a minimally invasive biopsy that does not
present a significant risk, AND

- Participant must agree to a biopsy as follows

- Disease-specific expansion cohorts: pre-treatment biopsy, unless medically
infeasible following consultation with the medical monitor

- Biology expansion cohort: pretreatment biopsy (required) and additional
on-treatment biopsy during Cycle 1 (unless medically infeasible following
consultation with the medical monitor)

- Measurable disease per the Response Evaluation Criteria in Solid Tumors Version 1.1
(RECIST v1.1) at baseline

- An Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

- Adequate renal, hepatic, and hematologic function

Exclusion Criteria

- History of another malignancy within 3 years before the first dose of study drug, or
any evidence of residual disease from a previously diagnosed malignancy.

- Known active central nervous system metastases

- Carcinomatous meningitis

- Previous receipt of monomethylauristatin E (MMAE)-containing drugs

- Pre-existing neuropathy ≥ Grade 2 per the National Cancer Institute's Common
Terminology Criteria for Adverse Events (NCI CTCAE) v5.0

- Any uncontrolled ≥ Grade 3 (per the NCI CTCAE, Version 5.0) viral, bacterial, or
fungal infection within 2 weeks prior to the first dose of SGN-STNV

There are additional inclusion and exclusion criteria. The study center will determine if
criteria for participation are met.

21-001