TerminatedPhase 1

A Study of SGN-STNV in Advanced Solid Tumors

Stopped: Study closed due to portfolio prioritization

United States, Canada, France111 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 range

18 Years

Sex

ALL

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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 range

18 Years

Sex

ALL

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