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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
Must not have
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
Pre-existing neuropathy ≥ Grade 2 per the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 3 years
Awards & highlights
No Placebo-Only Group

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.
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.
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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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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I have ovarian cancer.
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I have cervical cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not had another cancer or any signs of cancer in the last 3 years.
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I do not have severe nerve pain or damage.
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I have previously been treated with drugs containing MMAE.
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I have active cancer spread to my brain.
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I have cancer cells in the fluid around my brain and spinal cord.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of adverse events (AEs)
Incidence of dose limiting toxicities
Incidence of laboratory abnormalities
Secondary study objectives
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
210 Previous Clinical Trials
74,227 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
~23 spots leftby Jan 2026
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