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