Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
completion around

Description

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.

Official Title

A Phase 1 Study of SGN-STNV in Advanced Solid Tumors

Details

The study will include dose escalation (Part A) and dose expansion (Part B), with multiple disease-specific cohorts and a biology cohort in dose expansion. The biology cohort will require additional biopsies. At the completion of dose escalation, up to 5 disease specific expansion cohorts and 1 biology expansion cohort may be activated by the sponsor in consultation with the Safety Monitoring Committee (SMC). Expansion cohorts in Part B will enroll subjects with selected tumors that are eligible for enrollment in Part A. The dose(s) to be examined in Part B will be at or below the maximum tolerated dose and/or the recommended dose determined in Part A. The recommended dose and/or schedule may differ between cohorts.

Keywords

Carcinoma, Non-Small Cell Lung, HER2 Negative Breast Neoplasms, Ovarian Neoplasms, Uterine Cervical Neoplasms, Endometrial Neoplasms, Esophageal Neoplasms, Gastroesophageal Junction Carcinoma, Stomach Neoplasms, Colorectal Neoplasms, Exocrine Pancreatic Adenocarcinoma, Appendiceal Adenocarcinoma, Pseudomyxoma Peritonei, NSCLC, Non-Small Cell Lung Cancer, HER2-Negative Breast Cancer, High-Grade Serous Ovarian Cancer, HGSOC, Ovarian Cancer, Cervical Cancer, Endometrial Cancer, Esophageal Cancer, Gastric Cancer, GEJ Carcinoma, Colorectal Cancer, Seattle Genetics, Carcinoma, Neoplasms, Adenocarcinoma, Breast Neoplasms, Non-Small-Cell Lung Carcinoma, SGN-STNV

Eligibility

You can join if…

Open to people ages 18 years and up

  • Disease indication
  • 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

You CAN'T join if...

  • 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.

Locations

  • University of California at San Francisco
    San Francisco California 94158 United States
  • The Angeles Clinic and Research Institute
    Los Angeles California 90025 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Seagen Inc.
ID
NCT04665921
Phase
Phase 1 research study
Study Type
Interventional
Participants
About 111 people participating
Last Updated