A Study of SGN-B7H4V in Advanced Solid Tumors


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

- Non-small cell lung cancer (Squamous cell carcinoma [SqCC], Adenocarcinoma [AC])

- Cholangiocarcinoma or gallbladder carcinoma

- Adenoid cystic carcinoma (ACC) of the head and neck

- 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

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 5/2/23. 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


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