A Study of SGN-STNV in Advanced Solid Tumors

Sponsor

Seagen Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04665921

Collaborator

(none)

315

Enrollment

Locations

Arm

35.4

Anticipated Duration (Months)

18.5

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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
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	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 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

Study Type:

Interventional

Anticipated Enrollment :

315 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 :

Jan 18, 2021

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SGN-STNV SGN-STNV monotherapy	Drug: SGN-STNV Given into the vein (IV; intravenously)

Arm

Intervention/Treatment

Experimental: SGN-STNV

SGN-STNV monotherapy

Drug: SGN-STNV

Given into the vein (IV; intravenously)

Outcome Measures

Primary Outcome Measures

Incidence of adverse events (AEs) [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 [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 [Up to 28 days]
To be summarized using descriptive statistics

Secondary Outcome Measures

Objective response rate (ORR) as assessed by the investigator per RECIST v1.1 [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) [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) [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) [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) [Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years]
Pharmacokinetic (PK) endpoint
Time to maximum concentration (Tmax) [Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years]
PK endpoint
Maximum concentration (Cmax) [Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years]
PK endpoint
Trough concentration (Ctrough) [Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years]
PK endpoint
Incidence of antidrug antibodies (ADA) [Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years]
Immunogenicity endpoint

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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: pre-treatment 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Angeles Clinic and Research Institute	Los Angeles	California	United States	90025
2	University of California at San Francisco	San Francisco	California	United States	94158
3	Shands Cancer Center / University of Florida	Gainesville	Florida	United States	32610
4	University of Miami	Miami	Florida	United States	33136
5	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
6	Dana Farber Cancer Institute	Boston	Massachusetts	United States	02215
7	South Texas Accelerated Research Therapeutics Midwest	Grand Rapids	Michigan	United States	49546
8	Case Western Reserve University / University Hospitals Cleveland Medical Center	Cleveland	Ohio	United States	44106
9	Oregon Health and Science University	Portland	Oregon	United States	97239-3098
10	Magee Womens Hospital of UPMC	Pittsburgh	Pennsylvania	United States	15213
11	South Texas Accelerated Research Therapeutics	San Antonio	Texas	United States	78229
12	University of Ottawa / Ottawa General Hospital	Ottawa	Ontario	Canada	K1H 8L6
13	University Health Network, Princess Margaret Hospital	Toronto	Other	Canada	M5G 2C1
14	Institut Gustave Roussy	Villejuif Cedex	Other	France	94805
15	Istituto Europeo di Oncologia	Milan	Other	Italy	20141
16	Hospital Universitario Vall d'Hebron	Barcelona	Other	Spain	08035
17	The Royal Marsden Hospital (Surrey)	Sutton	Other	United Kingdom	SM2 5PT