NCT05377996

A Study of XMT-1660 in Participants With Solid Tumors

A Phase 1, First-in-human, Dose Escalation and Expansion, Multicenter Study of XMT-1660 in Participants With Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 319 (estimated)
• Sponsor: Mersana Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Study of XMT-1660 in Solid Tumors

Detailed description

This first-in-human (FIH) study will test the safety and side effects of a drug called XMT-1660. A side effect is anything a drug does to the body besides treating the disease. Participants in the study will have cancer that has come back after a period of time during which the cancer could not be detected (recurrent), spread in the body near where it started (advanced) or spread through the body (metastatic). The study will have two parts. The first part called Dose Escalation will find out how much XMT-1660 should be given to participants. The second part called Dose Expansion will use the dose found in the first part to find out how safe XMT-1660 is and if it works to treat solid tumor cancers.

Conditions

• Triple Negative Breast Cancer
• Breast Cancer
• Endometrial Cancer
• Ovarian Cancer
• Fallopian Tube Cancer
• Primary Peritoneal Cavity Cancer
• Adenoid Cystic Carcinoma

Interventions

Type	Name	Description
DRUG	XMT-1660	XMT-1660 will be administered through a vein in your arm or port catheter (intravenously)

Timeline

• Start date: 2022-08-15
• Primary completion: 2026-12-01
• Completion: 2027-05-01
• First posted: 2022-05-17
• Last updated: 2026-04-14

Locations

26 sites across 1 country: United States

Regulatory

• FDA-regulated drug study