A Study of SGN-STNV in Advanced Solid Tumors

• ClinicalTrials.gov Identifier: NCT04665921
• Recruitment Status: Terminated
• First Posted: December 14, 2020
• Last Update Posted: March 19, 2024
• Sponsor: Seagen Inc.
• Information provided by (Responsible Party): Seagen Inc.

Tracking Information

• First Submitted Date: December 7, 2020
• First Posted Date: December 14, 2020
• Last Update Posted Date: March 19, 2024
• Actual Study Start Date: January 18, 2021
• Actual Primary Completion Date: March 1, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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 (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: A Study of SGN-STNV in Advanced Solid Tumors
• Official Title: 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 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: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

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

Intervention

Drug: SGN-STNV

Given into the vein (IV; intravenously)

Study Arms

Experimental: SGN-STNV

SGN-STNV monotherapy

Intervention: Drug: SGN-STNV

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: October 3, 2023): 111
• Original Estimated Enrollment (submitted: December 7, 2020): 205
• Actual Study Completion Date: March 1, 2024
• Actual Primary Completion Date: March 1, 2024 (Final data collection date for primary outcome measure)

Eligibility 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.

    • 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada, France, Italy, Spain, United Kingdom, United States

Administrative Information

• NCT Number: NCT04665921
• Other Study ID Numbers: 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: Not Provided
• Current Responsible Party: Seagen Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Seagen Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Suzanne McGoldrick, MD; Seagen Inc.

• PRS Account: Seagen Inc.
• Verification Date: March 2024