A Study of SGN-STNV in Advanced Solid Tumors

• Status: Recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seagen Inc.

Criteria

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 a tumor site accessible for biopsy and agree to biopsy as follows:

• Disease-specific expansion cohorts, participant 13 onwards: pretreatment biopsy

• Biology expansion cohort: pretreatment biopsy and additional on-treatment biopsy during Cycle 1

• 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.