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A Study of SGN-STNV in Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT04665921
Recruitment Status : Recruiting
First Posted : December 14, 2020
Last Update Posted : February 18, 2021
Sponsor:
Information provided by (Responsible Party):
Seagen Inc.

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer (NSCLC) Human Epidermal Growth Factor Receptor 2 (HER2) Negative Breast Cancer Ovarian Cancer Cervical Cancer Endometrial Cancer Esophageal Cancer Gastric Cancer and Gastroesophageal Junction (GEJ) Carcinoma Colorectal Cancer Exocrine Pancreatic Adenocarcinoma Appendiceal Adenocarcinoma Pseudomyxoma Peritonei Drug: SGN-STNV Phase 1

Detailed 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 be gated based on data generated from other expansion cohorts and 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 205 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of SGN-STNV in Advanced Solid Tumors
Actual Study Start Date : January 18, 2021
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: SGN-STNV
SGN-STNV monotherapy
 Drug: SGN-STNV
Given into the vein (IV; intravenously)


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of adverse events (AEs) [ Time Frame: Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years ]
    To be summarized using descriptive statistics

  2. Incidence of laboratory abnormalities [ Time Frame: Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years ]
    To be summarized using descriptive statistics

  3. Incidence of dose limiting toxicities [ Time Frame: Up to 28 days ]
    To be summarized using descriptive statistics


Secondary Outcome Measures :
  1. Objective response rate (ORR) as assessed by the investigator per RECIST v1.1 [ Time Frame: Up to approximately 3 years ]
    ORR is defined as the proportion of subjects achieving a partial response (PR) or complete response (CR).

  2. Progression-free survival (PFS) [ Time Frame: Up to approximately 3 years ]
    PFS is defined as the time from the start of any study treatment to first documentation of disease progression or to death due to any cause, whichever comes first.

  3. Overall survival (OS) [ Time Frame: Up to approximately 3 years ]
    OS is defined as the time from the start of any study treatment to the date of death due to any cause.

  4. Duration of objective response (DOR) [ Time Frame: Up to approximately 3 years ]
    DOR is defined as the time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of tumor progression or to death due to any cause, whichever comes first.

  5. Area under the concentration-time curve (AUC) [ Time Frame: Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years ]
    Pharmacokinetic (PK) endpoint

  6. Time to maximum concentration (Tmax) [ Time Frame: Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years ]
    PK endpoint

  7. Maximum concentration (Cmax) [ Time Frame: Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years ]
    PK endpoint

  8. Trough concentration (Ctrough) [ Time Frame: Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years ]
    PK endpoint

  9. Incidence of antidrug antibodies (ADA) [ Time Frame: Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years ]
    Immunogenicity endpoint


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

      • 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
  • 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
  • Participants must have completed chemotherapy, immunotherapy, biologics, and/or other approved or investigational antitumor treatment prior to the first dose of study drug.
  • Participants of childbearing potential must have a negative serum or urine beta human chorionic gonadotropin (β hCG) pregnancy test result within 7 days prior to the first dose of SGN-STNV.

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 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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04665921


Contacts
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Contact: Seagen Trial Information Support 866-333-7436 clinicaltrials@seagen.com

Locations
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United States, Michigan
South Texas Accelerated Research Therapeutics Midwest Recruiting
Grand Rapids, Michigan, United States, 49546
Principal Investigator: Nehal Lakhani         
United States, Texas
South Texas Accelerated Research Therapeutics Recruiting
San Antonio, Texas, United States, 78229
Contact: Isabel Jimenez    210-593-5265    isabel.jimenez@startsa.com   
Principal Investigator: Amita Patnaik         
Sponsors and Collaborators
Seagen Inc.
Investigators
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Study Director: Suzanne McGoldrick, MD Seagen Inc.
More Information
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Responsible Party: Seagen Inc.
ClinicalTrials.gov Identifier: NCT04665921    
Other Study ID Numbers: SGNSTNV-001
First Posted: December 14, 2020    Key Record Dates
Last Update Posted: February 18, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Seagen Inc.:
Seattle Genetics
Additional relevant MeSH terms:
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Adenocarcinoma
Endometrial Neoplasms
Pseudomyxoma Peritonei
Neoplasms by Site
Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
 Neoplasms by Histologic Type
Genital Neoplasms, Female
Urogenital Neoplasms
Uterine Neoplasms
Uterine Diseases
Neoplasms, Cystic, Mucinous, and Serous