A Dose Escalation and Expansion Study of XB371 Administered in Participants with Locally Advanced or Metastatic Solid Tumors
Primary:
To characterize the safety and tolerability of XB371
Secondary:
To characterize the PK of XB371, total antibody (unconjugated and conjugated), and unconjugated payload (belotecan)
To characterize the immunogenicity of XB371
To determine the RDE of XB37a
To characterize the preliminary antitumor activity of XB371b
- Rutgers University
Key Inclusion Criteria: - Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. - Minimum life expectancy of ≥ 12 weeks. - Recurrent locally advanced or metastatic solid tumors. - Adequate end organ and bone marrow function. Key Exclusion Criteria: - Primary brain tumors or known active brain metastases, leptomeningeal, or cranial epidural disease. - History of interstitial lung disease (ILD) of any grade or history of organizing pneumonia. - Has acute ocular infection, acute or chronic ulcerative/cicatricial condition of conjunctiva or cornea. - Known history of immunodeficiency virus (HIV) unless specific criteria are met. - Active infection with hepatitis C virus (HCV) defined as positive for HCV antibody. - Major surgery within 4 weeks before the first dose of study treatment. - Received radiation therapy within 2 weeks before the first dose of study treatment. - Received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study treatment. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
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