Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of SGN-STNV in Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04665921
Recruitment Status : Recruiting
First Posted : December 14, 2020
Last Update Posted : October 5, 2021
Sponsor:
Information provided by (Responsible Party):
Seagen Inc.

Tracking Information
First Submitted Date  ICMJE December 7, 2020
First Posted Date  ICMJE December 14, 2020
Last Update Posted Date October 5, 2021
Actual Study Start Date  ICMJE January 18, 2021
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 7, 2020)
  • 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
  • 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
  • Incidence of dose limiting toxicities [ Time Frame: Up to 28 days ]
    To be summarized using descriptive statistics
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 16, 2021)
  • 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).
  • 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.
  • 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.
  • 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.
  • 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
  • Time to maximum concentration (Tmax) [ Time Frame: Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years ]
    PK endpoint
  • Maximum concentration (Cmax) [ Time Frame: Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years ]
    PK endpoint
  • Trough concentration (Ctrough) [ Time Frame: Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years ]
    PK endpoint
  • Incidence of antidrug antibodies (ADA) [ Time Frame: Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years ]
    Immunogenicity endpoint
Original Secondary Outcome Measures  ICMJE
 (submitted: December 7, 2020)
  • 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).
  • 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.
  • 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.
  • 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.
  • Area under the concentration-time curve (AUC) [ Time Frame: Through 30-37 days following last dose of SGN-TGT; up to approximately 3 years ]
    Pharmacokinetic (PK) endpoint
  • Time to maximum concentration (Tmax) [ Time Frame: Through 30-37 days following last dose of SGN-TGT; up to approximately 3 years ]
    PK endpoint
  • Maximum concentration (Cmax) [ Time Frame: Through 30-37 days following last dose of SGN-TGT; up to approximately 3 years ]
    PK endpoint
  • Trough concentration (Ctrough) [ Time Frame: Through 30-37 days following last dose of SGN-TGT; up to approximately 3 years ]
    PK endpoint
  • Incidence of antidrug antibodies (ADA) [ Time Frame: Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years ]
    Immunogenicity endpoint
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of SGN-STNV in Advanced Solid Tumors
Official Title  ICMJE A Phase 1 Study of SGN-STNV in Advanced Solid Tumors
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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • 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
Intervention  ICMJE Drug: SGN-STNV
Given into the vein (IV; intravenously)
Study Arms  ICMJE Experimental: SGN-STNV
SGN-STNV monotherapy
Intervention: Drug: SGN-STNV
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 30, 2021)
225
Original Estimated Enrollment  ICMJE
 (submitted: December 7, 2020)
205
Estimated Study Completion Date  ICMJE December 31, 2023
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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:

    • Disease-specific expansion cohorts, participant 13 onwards: pretreatment biopsy
    • Biology expansion cohort: pretreatment biopsy and additional on-treatment biopsy during Cycle 1
  • 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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Seagen Trial Information Support 866-333-7436 clinicaltrials@seagen.com
Listed Location Countries  ICMJE Canada,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04665921
Other Study ID Numbers  ICMJE SGNSTNV-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Seagen Inc.
Study Sponsor  ICMJE Seagen Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Suzanne McGoldrick, MD Seagen Inc.
PRS Account Seagen Inc.
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP