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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

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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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 3 years

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: SGN-STNVExperimental Treatment1 Intervention

SGN-STNV monotherapy

0 / 11Eligibility criteria met

Find a Location

Who is running the clinical trial?

Seagen Inc.Lead Sponsor

209 Previous Clinical Trials

74,264 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

~25 spots leftby Jul 2025

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