A Study of SGN-B7H4V in Advanced Solid Tumors

Overview

About this study

The purpose of this study is to test the safety and side effects of a drug called SGN-B7H4V in participants with solid tumors.  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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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) Version 5.0.
  • Corneal disease or injury requiring treatment or active monitoring.

Eligibility last updated 2/28/22. Questions regarding updates should be directed to the study team contact.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Gerardo Colon-Otero, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions