18 Years and up
Accepting Healthy Volunteers?
- Histologically or cytologically confirmed carcinoma (prostate cancer, renal cell
carcinoma, head and neck cancer, triple-negative breast cancer, bladder cancer,
non-small cell lung cancer) or melanoma that overexpresses B7-H3.
- Progressive disease during or after last treatment regimen.
- Appropriate treatment history for histological entity.
- ECOG Performance Status <= 1.
- Life expectancy >= 3 months.
- Measurable disease or evaluable disease with relevant tumor marker elevation.
- Acceptable laboratory parameters and adequate organ reserve.
- Major surgery or trauma within four weeks before enrollment.
- Known hypersensitivity to murine or recombinant proteins, polysorbate 80, or any
excipient contained in the drug formulation.
- Grade 3 colitis, hepatitis, pneumonitis uveitis, myocarditis, myositis, CNS toxicity
or autoimmune related neuromuscular toxicity such as myasthenia gravis associated with
the administration of an immune checkpoint inhibitor
- Second primary malignancy that has not been in remission for greater than 3 years.
Treated non-melanoma skin cancer, cervical carcinoma in situ on biopsy, or squamous
intraepithelial lesion on PAP smear, localized prostate cancer (Gleason score < 6), or
resected melanoma in situ are exceptions and do not require a 3 year remission.
- Active viral, bacterial, or systemic fungal infection requiring parenteral treatment
within four weeks of enrollment. Patients requiring any oral antiviral, fungal, or
bacterial therapy must have completed treatment within one week of enrollment.
- Vaccination within 2 weeks of enrollment (except for annual flu vaccine).
- History of chronic or recurrent infections that require continual use of antiviral,
antifungal, or antibacterial agents.