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TerminatedPhase 1NCT04665921
Official study title

A Study of SGN-STNV in Advanced Solid Tumors

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedSGN-STNV

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Feb 7, 2025 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?18 U.S. locations

Locations may change over time.

Who runs it?Seagen Inc.

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Seagen Inc.
Interventions being studied
Drug: SGN-STNV
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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) performance status score of 0 or 1
  • Adequate renal, hepatic, and hematologic function
Reasons someone may not be able to joinExclusion criteria
  • 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.
  • Known active central nervous system metastases
  • Carcinomatous meningitis
  • Previous receipt of monomethylauristatin E (MMAE)-containing drugs
  • Pre-existing neuropathy ≥ Grade 2 per the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
  • Any uncontrolled ≥ Grade 3 (per the NCI CTCAE, Version 5.0) viral, bacterial, or fungal infection within 2 weeks prior to the first dose of SGN-STNV There are additional inclusion and

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • The Angeles Clinic and Research InstituteLos Angeles, California
  • University of California, San Francisco | HDFCCC - Hematopoietic MalignanciesSan Francisco, California
  • Shands Cancer Center / University of FloridaGainesville, Florida
  • University of MiamiMiami, Florida
  • Beth Israel Deaconess Medical CenterBoston, Massachusetts
  • Dana Farber Cancer InstituteBoston, Massachusetts
  • South Texas Accelerated Research Therapeutics MidwestGrand Rapids, Michigan
  • Memorial Sloan Kettering Cancer CenterNew York, New York
  • University Hospitals Cleveland Medical CenterCleveland, Ohio
  • Oregon Health and Science UniversityPortland, Oregon
  • Magee Womens Hospital of UPMCPittsburgh, Pennsylvania
  • South Texas Accelerated Research TherapeuticsSan Antonio, Texas

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Feb 7, 2025. Always confirm current availability with the study team.

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