A Study of SGN-STNV in Advanced Solid Tumors

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.