A Study of SGN-B7H4V in Advanced Solid Tumors

April 12, 2024 updated by: Seagen Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

430

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • Recruiting
        • University of Ottawa / Ottawa General Hospital
        • Principal Investigator:
          • Arif Awan
  • Germany
    • Other
      • Berlin, Other, Germany, 10117
        • Recruiting
        • Charité Universitätsmedizin Berlin
        • Principal Investigator:
          • Antonia Busse
  • Italy
    • Other
      • Milano, Other, Italy, 20132
        • Recruiting
        • Instituto Europeo di Oncologia
        • Principal Investigator:
          • Giuseppe Curigliano
  • Spain
    • Other
      • Barcelona, Other, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron
        • Principal Investigator:
          • Elena Garralda Cabanas
      • Madrid, Other, Spain, 28050
        • Recruiting
        • START Madrid-CIOCC_Hospital HM Sanchinarro
        • Principal Investigator:
          • Irene Moreno Candilejo
  • United Kingdom
    • Other
      • London, Other, United Kingdom, W1G 6AD
        • Recruiting
        • Sarah Cannon Research Institute UK
        • Principal Investigator:
          • Elisa Fontana
  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado Hospital / University of Colorado
        • Principal Investigator:
          • Jennifer Diamond
        • Contact:
      • Denver, Colorado, United States, 80218
        • Recruiting
        • Sarah Cannon Research Institute at HealthONE - Denver
        • Principal Investigator:
          • Jason Henry
    • Florida
      • Celebration, Florida, United States, 34747
        • Recruiting
        • AdventHealth Cancer Institute
        • Principal Investigator:
          • Guru Sonpavde
        • Contact:
      • Jacksonville, Florida, United States, 32224
        • Recruiting
        • Mayo Clinic Florida
        • Contact:
        • Principal Investigator:
          • Gerardo Colon-Otero
      • Orlando, Florida, United States, 32827
        • Recruiting
        • Florida Cancer Specialists - Lake Nona
        • Principal Investigator:
          • Cesar Perez Batista, MD
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern University
        • Principal Investigator:
          • Aparna Kalyan, MBBS
        • Contact:
          • Northwestern University CT.Gov Contact
          • Phone Number: 312-695-1301
    • Indiana
      • Indianapolis, Indiana, United States, 46250
        • Recruiting
        • Community Health Network
        • Contact:
        • Principal Investigator:
          • Bert H O'Neil
    • Michigan
      • Grand Rapids, Michigan, United States, 49546
        • Recruiting
        • South Texas Accelerated Research Therapeutics Midwest
        • Principal Investigator:
          • Nehal Lakhani, MD, PhD
        • Contact:
          • Shannon Fabrie
          • Phone Number: 616-954-5559
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Tennessee Oncology-Nashville/Sarah Cannon Research Institute
        • Principal Investigator:
          • Erika P Hamilton
        • Contact:
          • Melanie Hurst
          • Phone Number: 615-979-9868
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • MD Anderson Cancer Center / University of Texas
        • Principal Investigator:
          • Renata Ferrarotto
        • Contact:
          • Amanda Drews
          • Phone Number: 832-834-1573
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • South Texas Accelerated Research Therapeutics
        • Contact:
        • Principal Investigator:
          • Amita Patnaik
    • Utah
      • West Valley City, Utah, United States, 84119
        • Recruiting
        • South Texas Accelerated Research Therapeutics Mountain Region
        • Principal Investigator:
          • Justin Call
        • Contact:
          • Casey Larsen
          • Phone Number: 801-907-4752

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete response rate (CRR)
Time Frame: Up to approximately 3 years
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)
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.
Up to approximately 3 years
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.
Up to approximately 3 years
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.
Up to approximately 3 years
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.
Through 30-37 days after last study treatment; up to approximately 3 years
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.
Through 30-37 days after last study treatment, up to approximately 3 years
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.
Through 30-37 days after last study treatment, up to approximately 3 years
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.
Through 30-37 days after last study treatment, up to approximately 3 years
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.
Through 30-37 days after last study treatment, up to approximately 3 years
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.
Through 30-37 days after last study treatment, up to approximately 3 years
Confirmed objective response rate (ORR) by investigator assessment
Time Frame: Up to approximately 3 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seagen Inc.

Investigators

  • Study Director: JoAl Mayor, PharmD, BCOP, Seagen Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2022

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

January 31, 2027

Study Registration Dates

First Submitted

January 3, 2022

First Submitted That Met QC Criteria

January 3, 2022

First Posted (Actual)

January 18, 2022

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 12, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SGNB7H4V-001
  • 2021-002107-35 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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