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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    315
  • sponsor
    Seagen Inc.
Updated on 28 October 2022
cancer
measurable disease
carcinoma
breast cancer
lung cancer
human chorionic gonadotropin
pancreatic adenocarcinoma
esophageal cancer
HER2
gastric cancer
cancer chemotherapy
adenocarcinoma
ovarian cancer
erbb2
esophagus cancer
cancer of the ovary
lung carcinoma

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.

Description

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.

Details
Condition 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
Treatment SGN-STNV
Clinical Study IdentifierNCT04665921
SponsorSeagen Inc.
Last Modified on28 October 2022

Eligibility

Yes No Not Sure

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 a tumor site accessible
for biopsy and agree to biopsy as follows
An Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
Disease-specific expansion cohorts: pre-treatment biopsy
Biology expansion cohort: pretreatment biopsy and additional on-treatment biopsy during Cycle 1
Adequate renal, hepatic, and hematologic function
Measurable disease per the Response Evaluation Criteria in Solid Tumors Version 1.1
(RECIST v1.1) at baseline

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
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How to participate?

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What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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