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Monoclonal Antibodies

SGN-STNV for Cancer

Phase 1
Waitlist Available
Research Sponsored by Seagen Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
HER2 negative breast cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 3 years
Awards & highlights
No Placebo-Only Group

Study Summary

This trial will test the safety and effectiveness of the drug SGN-STNV for treating solid tumors.

Who is the study for?
This trial is for adults with certain advanced solid tumors like breast, lung, ovarian, and cervical cancers that have not responded to standard treatments or if the patient cannot tolerate them. Participants must have measurable disease, be in good physical condition (ECOG score of 0 or 1), and have normal organ function. People with a recent history of other cancers, brain metastases, meningitis cancer-related, previous treatment with MMAE drugs, significant neuropathy or uncontrolled serious infections are excluded.Check my eligibility
What is being tested?
SGN-STNV is being tested for safety and effectiveness in treating various types of solid tumors. The study has two parts: Part A determines the right dose to give patients; Part B uses this dose to further evaluate safety and how well SGN-STNV works against specific tumor types.See study design
What are the potential side effects?
Potential side effects include any unintended actions besides treating cancer. Specific side effects aren't listed but generally could range from mild reactions at the injection site to more severe systemic responses affecting different organs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My condition has not improved with standard treatments or I cannot tolerate them.
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My breast cancer is not HER2 positive.
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I have ovarian cancer.
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I have cervical cancer.
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My condition has not improved with standard treatments or I cannot tolerate them.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My kidney, liver, and blood functions are all within normal ranges.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events (AEs)
Incidence of dose limiting toxicities
Incidence of laboratory abnormalities
Secondary outcome measures
Area under the concentration-time curve (AUC)
Duration of objective response (DOR)
Incidence of antidrug antibodies (ADA)
+6 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: SGN-STNVExperimental Treatment1 Intervention
SGN-STNV monotherapy

Find a Location

Who is running the clinical trial?

Seagen Inc.Lead Sponsor
206 Previous Clinical Trials
69,228 Total Patients Enrolled
Suzanne McGoldrick, MDStudy DirectorSeagen Inc.
1 Previous Clinical Trials
43 Total Patients Enrolled

Media Library

SGN-STNV (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04665921 — Phase 1
Non-Small Cell Lung Cancer Research Study Groups: SGN-STNV
Non-Small Cell Lung Cancer Clinical Trial 2023: SGN-STNV Highlights & Side Effects. Trial Name: NCT04665921 — Phase 1
SGN-STNV (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04665921 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial still recruiting participants?

"Yes, according to clinicaltrials.gov, this medical research is currently open for recruitment. The trial was launched on January 18th 2021 and last edited November 23rd 2022; it seeks 315 participants at 15 sites."

Answered by AI

What has been the verdict of regulatory authorities regarding SGN-STNV?

"Due to the scant amount of evidence for SGN-STNV's safety and efficacy, our team at Power gave this drug a score of 1."

Answered by AI

What are the intended outcomes of this clinical exploration?

"The main objective of the study, to be monitored over a span of up to 3 years post-treatment, is tracking laboratory abnormalities. Additional secondary goals include assessing overall survival rate, duration of response efficiency and peak plasma concentration time."

Answered by AI

What is the reach of this research project?

"15 sites are participating in this medical trial, including the University of Ottawa / Ottawa General Hospital, The Angeles Clinic and Research Institute, Beth Israel Deaconess Medical Center as well as a dozen additional locations."

Answered by AI

To what extent is the study population involved in this research?

"Indeed, per the information on clinicaltrials.gov, this research endeavor is actively seeking out eligible candidates. It was first published on January 18th 2021 and last modified November 23rd 2022. 315 participants are required for data collection at 15 trial sites."

Answered by AI

Who else is applying?

How old are they?
65+
What portion of applicants met pre-screening criteria?
Did not meet criteria
~29 spots leftby Mar 2025