A Study of SGN-STNV in Advanced Solid Tumors

Colorectal Neoplasms Clinical Trial

Official title:

A Phase 1 Study of SGN-STNV in Advanced Solid Tumors

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04665921
• Other study ID #: SGNSTNV-001
• Status: Terminated
• Phase: Phase 1
• Start date: January 18, 2021
• Est. completion date: March 1, 2024

Study information

• Verified date: March 2024
• Source: Seagen Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 111
• Est. completion date: March 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Appendiceal Adenocarcinoma
• Breast Neoplasms
• Carcinoma
• Carcinoma, Non-Small Cell Lung
• Carcinoma, Non-Small-Cell Lung
• Colorectal Neoplasms
• Endometrial Neoplasms
• Esophageal Neoplasms
• Exocrine Pancreatic Adenocarcinoma
• Gastroesophageal Junction Carcinoma
• Neoplasms
• Ovarian Neoplasms
• Pseudomyxoma Peritonei
• Stomach Neoplasms
• Uterine Cervical Neoplasms

Intervention

Drug:
• SGN-STNV
Given into the vein (IV; intravenously)

Locations

Country	Name	City	State
Canada	University of Ottawa / Ottawa General Hospital	Ottawa	Ontario
Canada	University Health Network, Princess Margaret Hospital	Toronto	Other
France	Institut Gustave Roussy	Villejuif Cedex	Other
Italy	Istituto Europeo di Oncologia	Milano	Other
Spain	Hospital Universitari Vall d'Hebron	Barcelona	Other
United Kingdom	The Royal Marsden Hospital (Surrey)	Sutton	Other
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	Shands Cancer Center / University of Florida	Gainesville	Florida
United States	South Texas Accelerated Research Therapeutics Midwest	Grand Rapids	Michigan
United States	The Angeles Clinic and Research Institute	Los Angeles	California
United States	University of Miami	Miami	Florida
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Magee Womens Hospital of UPMC	Pittsburgh	Pennsylvania
United States	Oregon Health and Science University	Portland	Oregon
United States	South Texas Accelerated Research Therapeutics	San Antonio	Texas
United States	University of California, San Francisco | HDFCCC - Hematopoietic Malignancies	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Seagen Inc.

Countries where clinical trial is conducted

United States,  Canada,  France,  Italy,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events (AEs)	To be summarized using descriptive statistics	Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years
Primary	Incidence of laboratory abnormalities	To be summarized using descriptive statistics	Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years
Primary	Incidence of dose limiting toxicities	To be summarized using descriptive statistics	Up to 28 days
Secondary	Objective response rate (ORR) as assessed by the investigator per RECIST v1.1	ORR is defined as the proportion of subjects achieving a partial response (PR) or complete response (CR).	Up to approximately 3 years
Secondary	Progression-free survival (PFS)	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.	Up to approximately 3 years
Secondary	Overall survival (OS)	OS is defined as the time from the start of any study treatment to the date of death due to any cause.	Up to approximately 3 years
Secondary	Duration of objective response (DOR)	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.	Up to approximately 3 years
Secondary	Area under the concentration-time curve (AUC)	Pharmacokinetic (PK) endpoint	Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years
Secondary	Time to maximum concentration (Tmax)	PK endpoint	Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years
Secondary	Maximum concentration (Cmax)	PK endpoint	Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years
Secondary	Trough concentration (Ctrough)	PK endpoint	Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years
Secondary	Incidence of antidrug antibodies (ADA)	Immunogenicity endpoint	Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years