A Study of SGN-B7H4V in Advanced Solid Tumors

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:

A Phase 1 Study of SGN-B7H4V in Advanced Solid Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05194072
• Other study ID #: SGNB7H4V-001
• Secondary ID: 2021-002107-35
• Status: Recruiting
• Phase: Phase 1
• Start date: January 12, 2022
• Est. completion date: January 31, 2027

Study information

• Verified date: June 2024
• Source: Seagen Inc.
• Contact: Seagen Trial Information Support
• Phone: 866-333-7436
• Email: clinicaltrials[@]seagen.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will test the safety of a drug called SGN-B7H4V in participants with solid tumors. It will also study the side effects of this drug. A side effect is anything a drug does to the body besides treating the disease.

Participants will have cancer that has spread in the body near where it started (locally advanced) and cannot be removed (unresectable) or has spread through the body (metastatic).

This study will have three parts. Parts A and B of the study will find out how much SGN-B7H4V should be given to participants. Part C will use the dose found in Parts A and B to find out how safe SGN-B7H4V is and if it works to treat solid tumor cancers.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 430
• Est. completion date: January 31, 2027
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participants must have one of the following histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumor types:

• High-grade serous epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer

• HER2-negative, HR positive breast cancer

• Triple-negative breast cancer (TNBC)

• Endometrial carcinoma

• Non-small cell lung cancer (Squamous cell carcinoma [SqCC], Adenocarcinoma [AC])

• Cholangiocarcinoma or gallbladder carcinoma

• Adenoid cystic carcinoma (ACC)

• Parts A and B: Participants must have disease that is relapsed or refractory or be intolerant to SOC therapies, and, in the judgement of the investigator, should have no appropriate SOC therapeutic option

• Part C: Participants must have disease that is relapsed or refractory or be intolerant to SOC therapies, unless contraindicated

• Tumor tissue is required for enrollment.

• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

• Measurable disease per RECIST version 1.1 at baseline

Exclusion Criteria:

• History of another malignancy within 3 years before the first dose of study drug. Any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death.

• Known active central nervous system metastases. Participants with previously treated brain metastases may participate provided they:

• are clinically stable for at least 4 weeks prior to study entry after brain metastasis treatment

• have no new or enlarging brain metastases

• and are off corticosteroids prescribed for symptoms associated with brain metastases for at least 7 days prior to the first dose of study treatment.

• Carcinomatous meningitis

• Previous receipt of an MMAE-containing agent or an agent targeting B7-H4

• Pre-existing neuropathy = Grade 2 per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0

• Corneal disease or injury requiring treatment or active monitoring

Related Conditions & MeSH terms

• Adenoid Cystic Carcinoma
• Breast Neoplasms
• Carcinoma
• Carcinoma, Adenoid Cystic
• Carcinoma, Non-Small-Cell Lung
• Cholangiocarcinoma
• Endometrial Neoplasms
• Fallopian Tube Neoplasms
• Gallbladder Carcinoma
• Neoplasms
• Ovarian Neoplasms
• Peritoneal Neoplasms
• Triple Negative Breast Neoplasms

Intervention

Drug:
• SGN-B7H4V
Given into the vein (IV; intravenously)

Locations

Country	Name	City	State
Canada	McGill University Department of Oncology / McGill University Health Centre	Montreal	Quebec
Canada	University of Ottawa / Ottawa General Hospital	Ottawa	Ontario
Germany	Charite Universitatsmedizin Berlin	Berlin	Other
Italy	Instituto Europeo di Oncologia	Milano	Other
Spain	Hospital Universitari Vall d'Hebron	Barcelona	Other
Spain	START Madrid-CIOCC_Hospital HM Sanchinarro	Madrid	Other
United Kingdom	Sarah Cannon Research Institute UK	London	Other
United States	University of Colorado Hospital / University of Colorado	Aurora	Colorado
United States	AdventHealth Cancer Institute	Celebration	Florida
United States	Northwestern University	Chicago	Illinois
United States	Sarah Cannon Research Institute at HealthONE - Denver	Denver	Colorado
United States	South Texas Accelerated Research Therapeutics Midwest	Grand Rapids	Michigan
United States	MD Anderson Cancer Center / University of Texas	Houston	Texas
United States	Community Health Network	Indianapolis	Indiana
United States	Mayo Clinic Florida	Jacksonville	Florida
United States	SCRI Oncology Partners	Nashville	Tennessee
United States	Florida Cancer Specialists - Lake Nona	Orlando	Florida
United States	South Texas Accelerated Research Therapeutics	San Antonio	Texas
United States	South Texas Accelerated Research Therapeutics Mountain Region	West Valley City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Seagen Inc.

Countries where clinical trial is conducted

United States,  Canada,  Germany,  Italy,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events (AEs)	Any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment.	Through 30 days after last study treatment, up to approximately 3 years
Primary	Number of participants with laboratory abnormalities		Through 30-37 days after last study treatment, up to approximately 3 years
Primary	Number of participants with dose limiting toxicities (DLTs)		Up to 28 days
Secondary	Confirmed objective response rate (ORR) by investigator assessment	The proportion of participants with complete response (CR) or partial response (PR) which is subsequently confirmed as assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by investigator.	Up to approximately 3 years
Secondary	Complete response rate (CRR)	The proportion of participants achieving a CR as determined by the investigator per RECIST Version 1.1.	Up to approximately 3 years
Secondary	Duration of response (DOR)	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.	Up to approximately 3 years
Secondary	Progression-free survival (PFS)	The time from the start of any study treatment to first documentation of disease progression or to death due to any cause.	Up to approximately 3 years
Secondary	Overall survival (OS)	The time from the start of any study treatment to the date of death due to any cause.	Up to approximately 3 years
Secondary	Pharmacokinetic (PK) parameter - Area under the curve (AUC)	To be summarized using descriptive statistics.	Through 30-37 days after last study treatment; up to approximately 3 years
Secondary	PK parameter - Maximum concentration (Cmax)	To be summarized using descriptive statistics.	Through 30-37 days after last study treatment, up to approximately 3 years
Secondary	PK parameter - Time to maximum concentration (Tmax)	To be summarized using descriptive statistics.	Through 30-37 days after last study treatment, up to approximately 3 years
Secondary	PK parameter - Apparent terminal half-life (t1/2)	To be summarized using descriptive statistics.	Through 30-37 days after last study treatment, up to approximately 3 years
Secondary	PK parameter - Trough concentration (Ctrough)	To be summarized using descriptive statistics.	Through 30-37 days after last study treatment, up to approximately 3 years
Secondary	Incidence of antidrug antibodies (ADAs)	To be summarized using descriptive statistics.	Through 30-37 days after last study treatment, up to approximately 3 years