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- MER-XMT-1536-1/GOG 3048: A Phase 1b/2, First-in-Human, Dose Escalation and Expansion Study of XMT-1536 In Patients with Solid Tumors Likely to Express NaPi2b
Clinical Trial
MER-XMT-1536-1/GOG 3048: A Phase 1b/2, First-in-Human, Dose Escalation and Expansion Study of XMT-1536 In Patients with Solid Tumors Likely to Express NaPi2b
This study is divided into 3 parts. The first part is completed leaving the 2nd and 3rd parts remaining in this research. The first part examined the targeted therapy of XMT-1536. The study drug is made of two parts, the firts part is the antibody that binds to NaPi2b (sodium-dependent phosphate transporter) a protien on the surface of the cells of your tumor. The second part is a cancer medicine that is attached to the antibody. When the antibody binds to the transporter, it carries the cancer medicine directly into the tumor cells to kill them. The second part of this study is to study the expansion dose of XMT-1563based on the data from the first partof the study to ensure that it can be tolerated and seems resonably safe. Also, to see how long it stays in the body and if it causes changes to the body and at what dose these changes take place. The third part is to confirm the response rate of patients with ovarian cancer with higher and lower NaPi2b scores, and to see how long it remains in the blood.
Eligibility Criteria
- Eligible subjects will be females and males 18 years of age and older ECOG performance status of 0 or 1. Subjects must have measurable disease as per RECIST, version 1.1. Subjects who have had major surgery within 28 days of starting study treatment, systemic anti-cancer therapy wihtin the lesser of 28 days or 5 half-lives of the prior therapy before starting study treatment, or recent radiation therapy with unresolved toxicity or within a time window of potential toxicity will not be considered.