TerminatedPhase 1

A Study of SGN-STNV in Advanced Solid Tumors

Stopped: Study closed due to portfolio prioritization

United States111 participantsStarted 2021-01-18

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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) perfo…

What they're measuring

Incidence of adverse events (AEs)

Timeframe: Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years

Incidence of laboratory abnormalities

Timeframe: Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years

Incidence of dose limiting toxicities

Timeframe: Up to 28 days

Trial details

NCT IDNCT04665921

SponsorSeagen Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-03-01

View on ClinicalTrials.gov More Carcinoma, Non-Small Cell Lung trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Incidence of adverse events (AEs)

Timeframe: Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years

Incidence of laboratory abnormalities

Timeframe: Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years

Incidence of dose limiting toxicities

Timeframe: Up to 28 days