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Carcinoma, Non-Small Cell Lung
+11

A Study of SGN-STNV in Advanced Solid Tumors

Sponsored by Seagen Inc.

About this trial

Last updated a year ago

Study ID

SGNSTNV-001

Status

Terminated

Type

Interventional

Phase

Phase 1

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended a year ago

What is this trial about?

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.

What are the participation requirements?

Yes

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

No

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.

Locations

Location

Status