Clinical trial NCT04665921: A Study of SGN-STNV in Advanced Solid Tumors
Official title: A Phase 1 Study of SGN-STNV in Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: 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
Keywords: 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
Lead sponsor: Seagen Inc.
Sponsor class: INDUSTRY
First posted: 2020-12-14
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Incidence of adverse events (AEs)
timeFrame: Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years
measure: Incidence of laboratory abnormalities
timeFrame: Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years
measure: Incidence of dose limiting toxicities
timeFrame: Up to 28 days
Secondary outcomes:
measure: Objective response rate (ORR) as assessed by the investigator per RECIST v1.1
timeFrame: Up to approximately 3 years
measure: Progression-free survival (PFS)
timeFrame: Up to approximately 3 years
measure: Overall survival (OS)
timeFrame: Up to approximately 3 years
measure: Duration of objective response (DOR)
timeFrame: Up to approximately 3 years
measure: Area under the concentration-time curve (AUC)
timeFrame: Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years
measure: Time to maximum concentration (Tmax)
timeFrame: Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years
measure: Maximum concentration (Cmax)
timeFrame: Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years
measure: Trough concentration (Ctrough)
timeFrame: Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years
measure: Incidence of antidrug antibodies (ADA)
timeFrame: Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: The Angeles Clinic and Research Institute
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco | HDFCCC - Hematopoietic Malignancies
state: California
city: Gainesville
country: United States
facility: Shands Cancer Center / University of Florida
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Grand Rapids
country: United States
facility: South Texas Accelerated Research Therapeutics Midwest
state: Michigan
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Pittsburgh
country: United States
facility: Magee Womens Hospital of UPMC
state: Pennsylvania
city: San Antonio
country: United States
facility: South Texas Accelerated Research Therapeutics
state: Texas
city: Ottawa
country: Canada
facility: University of Ottawa / Ottawa General Hospital
state: Ontario
city: Toronto
country: Canada
facility: University Health Network, Princess Margaret Hospital
state: Other
city: Villejuif Cedex
country: France
facility: Institut Gustave Roussy
state: Other
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia
state: Other
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
state: Other
city: Sutton
country: United Kingdom
facility: The Royal Marsden Hospital (Surrey)
state: Other
Study officials:
affiliation: Seagen Inc.
name: Suzanne McGoldrick, MD
role: STUDY_DIRECTOR
References: