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A Study of XMT-1660 in Participants With Solid Tumors

Status
Active
Cancer Type
Solid Tumor
Unknown Primary
Trial Phase
Phase I
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT05377996
Protocol IDs
MER-XMT-1660-1 (primary)
NCI-2022-04696
Study Sponsor
Mersana Therapeutics

Summary

A Study of XMT-1660 in Solid Tumors

Objectives

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.

Eligibility

  1. Recurrent or advanced solid tumor and has disease progression after treatment with available anti-cancer therapies known to confer benefit or is intolerant to treatment.
  2. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  3. At least one measurable lesion(s) as defined by RECIST version 1.1.
  4. Tumor tissue, either archival or from a fresh tumor biopsy, available for testing or be willing to undergo a minimally invasive tumor biopsy to obtain tumor tissue for local testing, if not medically contraindicated, prior to Cycle 1 Day 1
  5. Brain magnetic resonance imaging (MRI) during the Pre- Screening/Screening period unless obtained within 30 days prior to enrollment (based on standard clinical care), if they meet either of the following criteria:
  6. All participants with TNBC
  7. Participants with a history of brain metastases or with neurologic symptoms or signs suspicious for brain metastases.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
Georgia CORE

 

Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.