A Study of SGN-B7H4V in Advanced Solid Tumors

Sponsor

Seagen Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05194072

Collaborator

(none)

355

Enrollment

Locations

Arm

60.6

Anticipated Duration (Months)

50.7

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Ovarian Neoplasms Peritoneal Neoplasms Fallopian Tube Neoplasms Triple Negative Breast Neoplasms HER2 Negative Breast Neoplasms Hormone Receptor Positive Breast Neoplasms Endometrial Neoplasms Carcinoma, Non-Small-Cell Lung Cholangiocarcinoma Gallbladder Carcinoma	Drug: SGN-B7H4V	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

355 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 12, 2022

Anticipated Primary Completion Date :

Jun 30, 2025

Anticipated Study Completion Date :

Jan 31, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SGN-B7H4V SGN-B7H4V monotherapy	Drug: SGN-B7H4V Given into the vein (IV; intravenously)

Arm

Intervention/Treatment

Experimental: SGN-B7H4V

SGN-B7H4V monotherapy

Drug: SGN-B7H4V

Given into the vein (IV; intravenously)

Outcome Measures

Primary Outcome Measures

Number of participants with adverse events (AEs) [Through 30 days after last study treatment, up to approximately 3 years]
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.
Number of participants with laboratory abnormalities [Through 30-37 days after last study treatment, up to approximately 3 years]
Number of participants with dose limiting toxicities (DLTs) [Up to 28 days]

Secondary Outcome Measures

Objective response rate (ORR) [Up to approximately 3 years]
The proportion of subjects achieving a partial response (PR), or complete response (CR) as assessed by the investigator per RECIST Version 1.1.
Complete response rate (CRR) [Up to approximately 3 years]
The proportion of subjects achieving a CR as determined by the investigator per RECIST Version 1.1.
Duration of response (DOR) [Up to approximately 3 years]
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.
Progression-free survival (PFS) [Up to approximately 3 years]
The time from the start of any study treatment to first documentation of disease progression or to death due to any cause.
Overall survival (OS) [Up to approximately 3 years]
The time from the start of any study treatment to the date of death due to any cause.
Pharmacokinetic (PK) parameter - Area under the curve (AUC) [Through 30-37 days after last study treatment; up to approximately 3 years]
To be summarized using descriptive statistics.
PK parameter - Maximum concentration (Cmax) [Through 30-37 days after last study treatment, up to approximately 3 years]
To be summarized using descriptive statistics.
PK parameter - Time to maximum concentration (Tmax) [Through 30-37 days after last study treatment, up to approximately 3 years]
To be summarized using descriptive statistics.
PK parameter - Apparent terminal half-life (t1/2) [Through 30-37 days after last study treatment, up to approximately 3 years]
To be summarized using descriptive statistics.
PK parameter - Trough concentration (Ctrough) [Through 30-37 days after last study treatment, up to approximately 3 years]
To be summarized using descriptive statistics.
Incidence of antidrug antibodies (ADAs) [Through 30-37 days after last study treatment, up to approximately 3 years]
To be summarized using descriptive statistics.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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
Squamous non-small cell lung cancer (Sq-NSCLC)
Cholangiocarcinoma or gallbladder carcinoma
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: Subjects must have disease that is relapsed or refractory or be intolerant to SOC therapies, unless contraindicated
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) Version5.0
Corneal disease or injury requiring treatment or active monitoring

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Colorado Hospital / University of Colorado	Aurora	Colorado	United States	80045
2	Sarah Cannon Research Institute at HealthONE - Denver	Denver	Colorado	United States	80218
3	Florida Cancer Specialists - Lake Nona	Orlando	Florida	United States	32827
4	South Texas Accelerated Research Therapeutics Midwest	Grand Rapids	Michigan	United States	49546
5	Tennessee Oncology-Nashville/Sarah Cannon Research Institute	Nashville	Tennessee	United States	37203
6	South Texas Accelerated Research Therapeutics	San Antonio	Texas	United States	78229
7	South Texas Accelerated Research Therapeutics Mountain Region	West Valley City	Utah	United States	84119