A Study of SGN-B7H4V in Advanced Solid Tumors

Study Overview
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Brief Summary
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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.

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

Conditions
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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, Adenoid Cystic Carcinoma

Intervention / Treatment
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* Drug: SGN-B7H4V


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SGN-B7H4V<br>SGN-B7H4V monotherapy | Drug: SGN-B7H4V<br>* Given into the vein (IV; intravenously)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| PK parameter - Maximum concentration (Cmax) | To be summarized using descriptive statistics. | Through 30-37 days after last study treatment, up to approximately 3 years | 
| 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 | 
| 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 | 
| PK parameter - Trough concentration (Ctrough) | To be summarized using descriptive statistics. | Through 30-37 days after last study treatment, up to approximately 3 years | 
| Incidence of antidrug antibodies (ADAs) | To be summarized using descriptive statistics. | Through 30-37 days after last study treatment, up to approximately 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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High-grade serous epithelial ovarian cancer, Primary peritoneal cancer, Fallopian tube cancer, HER2-negative breast cancer, HR positive breast cancer, Triple-negative breast cancer, TNBC, Endometrial carcinoma, Non-small cell lung cancer, NSCLC, SqCC, AC, ACC, Seattle Genetics