A Study of XMT-1660 in Participants With Solid Tumors
Solid Tumor
Unknown Primary
18 Years and older, Male and Female
MER-XMT-1660-1 (primary)
NCI-2022-04696
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
- Recurrent or advanced solid tumor and has disease
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Participants in DES must have at least one non-target lesion as defined by RECIST version 1.1. Participants in Backfill Cohorts and EXP must have at least one measurable disease (target) lesion as defined by RECIST version 1.1.
- 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
- Brain magnetic resonance imaging (MRI) during the Screening period unless obtained within 30 days prior to Screening (based on standard clinical care), if they meet either of the following criteria:
- All participants with TNBC
- Participants with a history of brain metastases or with neurologic symptoms or signs suspicious for brain metastases.
Treatment Sites in Georgia
**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...
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