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Clinical Trial 18825
Study Type: Treatment
Phase of Study: Phase I
- Hatem Soliman
A Phase 1b, First-in-Human, Dose Escalation and Expansion Study of XMT-1522 in Patients with Advanced Breast Cancer and Other Advanced Tumors Expressing HER2
The purposes of the first part of this study are: To find the highest dose of XMT-1522 that can be tolerated and seems reasonably safe; To gather information on how participants react to receiving XMT-1522; To evaluate how long XMT-1522 stays in the blood, at what level and what changes, if any, XMT-1522 causes. For example, does the participant's body develop proteins that work against the XMT-1522 or does their tumor change in size after receiving XMT-1522?
1 PRIMARY OBJECTIVES: Dose Escalation (DES): 1.1. Determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of XMT-1522 administered intravenously once every three weeks. 1.2. Assess the safety and tolerability of XMT-1522. Expansion (EXP): 1.3. Assess further the safety and tolerability of XMT-1522 administered at the MTD/RP2D identified in the DES. 1.4. Assess the preliminary anti-neoplastic activity of XMT-1522. 2 SECONDARY OBJECTIVES: DES and EXP: 2.1. Assess the pharmacokinetics (PK) of XMT-1522, its release product, and selected metabolites. 2.2. Assess the development of anti-drug antibodies to XMT-1522. DES Only: 2.3. Assess the preliminary anti-neoplastic activity of XMT-1522. 3 EXPLORATORY OBJECTIVE: 3.1. Retrospectively evaluate the association of objective response and alternative assays for measurement of HER2 expression.