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A Study of SGN-B7H4V in Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05194072
Recruitment Status : Recruiting
First Posted : January 18, 2022
Last Update Posted : May 6, 2022
Sponsor:
Information provided by (Responsible Party):
Seagen Inc.

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : January 12, 2022
Estimated Primary Completion Date : June 30, 2025
Estimated Study Completion Date : January 31, 2027


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




Primary Outcome Measures :
  1. Number of participants with adverse events (AEs) [ Time Frame: 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.

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

Secondary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: 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.

  2. Complete response rate (CRR) [ Time Frame: Up to approximately 3 years ]
    The proportion of subjects achieving a CR as determined by the investigator per RECIST Version 1.1.

  3. Duration of response (DOR) [ Time Frame: 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.

  4. Progression-free survival (PFS) [ Time Frame: 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.

  5. Overall survival (OS) [ Time Frame: Up to approximately 3 years ]
    The time from the start of any study treatment to the date of death due to any cause.

  6. Pharmacokinetic (PK) parameter - Area under the curve (AUC) [ Time Frame: Through 30-37 days after last study treatment; up to approximately 3 years ]
    To be summarized using descriptive statistics.

  7. PK parameter - Maximum concentration (Cmax) [ Time Frame: Through 30-37 days after last study treatment, up to approximately 3 years ]
    To be summarized using descriptive statistics.

  8. PK parameter - Time to maximum concentration (Tmax) [ Time Frame: Through 30-37 days after last study treatment, up to approximately 3 years ]
    To be summarized using descriptive statistics.

  9. PK parameter - Apparent terminal half-life (t1/2) [ Time Frame: Through 30-37 days after last study treatment, up to approximately 3 years ]
    To be summarized using descriptive statistics.

  10. PK parameter - Trough concentration (Ctrough) [ Time Frame: Through 30-37 days after last study treatment, up to approximately 3 years ]
    To be summarized using descriptive statistics.

  11. Incidence of antidrug antibodies (ADAs) [ Time Frame: Through 30-37 days after last study treatment, up to approximately 3 years ]
    To be summarized using descriptive statistics.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05194072


Contacts
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Contact: Seagen Trial Information Support 866-333-7436 clinicaltrials@seagen.com

Locations
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United States, Colorado
Sarah Cannon Research Institute at HealthONE - Denver Recruiting
Denver, Colorado, United States, 80218
Contact: Sarah Kirk    720-754-2610      
Principal Investigator: Jason Henry         
United States, Florida
Florida Cancer Specialists - Lake Nona Recruiting
Orlando, Florida, United States, 32827
Contact: Shannon Thomas-Lohrman    689-216-8510      
Principal Investigator: Cesar Perez Perez Batista, MD         
United States, Michigan
South Texas Accelerated Research Therapeutics Midwest Recruiting
Grand Rapids, Michigan, United States, 49546
Contact: Katie Robinson    616-389-1739      
Principal Investigator: Nehal Lakhani, MD, PhD         
United States, Tennessee
Tennessee Oncology-Nashville/Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
Contact: Autumn Teal    615-946-0592      
Principal Investigator: Erika P Hamilton         
United States, Texas
South Texas Accelerated Research Therapeutics Recruiting
San Antonio, Texas, United States, 78229
Contact: Isabel Jimenez    210-593-5265      
Principal Investigator: Amita Patnaik         
United States, Utah
South Texas Accelerated Research Therapeutics Mountain Region Recruiting
West Valley City, Utah, United States, 84119
Contact: Casey Larsen    801-907-4752      
Principal Investigator: Justin Call         
Sponsors and Collaborators
Seagen Inc.
Investigators
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Study Director: Natalya Nazarenko, MD Seagen Inc.
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Responsible Party: Seagen Inc.
ClinicalTrials.gov Identifier: NCT05194072    
Other Study ID Numbers: SGNB7H4V-001
2021-002107-35 ( EudraCT Number )
First Posted: January 18, 2022    Key Record Dates
Last Update Posted: May 6, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Seagen Inc.:
High-grade serous epithelial ovarian cancer
Primary peritoneal cancer
Fallopian tube cancer
HER2 Negative Breast Neoplasms
HER2 Positive Breast Neoplasms
Triple Negative Breast Neoplasms
HER2-negative breast cancer
HER2-positive breast cancer
Triple-negative breast cancer
TNBC
Endometrial carcinoma
Squamous non-small cell lung cancer
Sq-NSCLC
Seattle Genetics
Additional relevant MeSH terms:
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Carcinoma
Neoplasms
Cholangiocarcinoma
Breast Neoplasms
Carcinoma, Non-Small-Cell Lung
Ovarian Neoplasms
Endometrial Neoplasms
Peritoneal Neoplasms
Triple Negative Breast Neoplasms
Fallopian Tube Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adenocarcinoma
Neoplasms by Site
Breast Diseases
Skin Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders