TerminatedPhase 1NCT04665921

A Study of SGN-STNV in Advanced Solid Tumors

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.

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

StatusTerminated
PhasePhase 1
U.S. locations18
SponsorSeagen Inc.
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.

03
Public criteria

Who may be able to participate

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) performance status score of 0 or 1 * Adequate renal, hepatic, and hematologic function Exclusion 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 exclusion criteria. The study center will determine if criteria for participation are met.

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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