Discovery and Preclinical Characterization of XMT-1660, an Optimized B7-H4-Targeted Antibody-Drug Conjugate for the Treatment of Cancer.
Dorin Toader, Shawn P Fessler, Scott D Collins...
https://pubmed.ncbi.nlm.nih.gov/37294948Actively Recruiting
Phase 1
Age: 18Years +
All Genders
ID05377996
A Phase 1 First-in-Human Dose Escalation and Expansion Study of XMT-1660 in Participants With Solid Tumors
Led by Mersana Therapeutics · Updated on 2026-04-14
319
Participants Needed
26
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the drug XMT-1660 in people with solid tumors that are recurrent, advanced, or have spread (metastatic). This first-in-human study aims to test the safety, side effects, and potential effectiveness of XMT-1660 in treating various solid tumors including breast, ovarian, endometrial, and other cancers. The study has two parts: Dose Escalation to determine the safe dosage, and Dose Expansion to further study safety and treatment response. Participants receive XMT-1660 through a vein in the arm or port catheter (intravenously) as a single-agent treatment. The Dose Escalation phase identifies the appropriate dose, while the Dose Expansion phase uses that dose to assess safety and tumor response. The study does not use placebo or comparison groups; all participants receive XMT-1660 alone. During the study, participants undergo regular monitoring for side effects and treatment response, including imaging and tumor assessments based on RECIST criteria. Brain MRI is required for certain participants before treatment. Researchers measure adverse events, tumor response rates, drug concentration in the blood, and immune responses against the drug. The study continues with follow-up assessments for up to approximately three years to evaluate safety and effectiveness.
CONDITIONS
Brief Title
A Study of XMT-1660 in Participants With Solid Tumors
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Recurrent or advanced solid tumor with disease present
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Participants in Dose Expansion must have at least one measurable disease lesion as defined by RECIST 1.1
- Tumor tissue available for testing or willingness to undergo tumor biopsy prior to treatment
- Brain MRI during screening if participant has triple negative breast cancer or history/symptoms of brain metastases
You will not qualify if you...
- Prior treatment with an antibody drug conjugate containing an auristatin payload
- Major surgery within 28 days before starting study treatment
- Systemic anticancer therapy within 28 days or 5 half-lives of prior therapy before treatment (or 14 days for small molecule targeted therapy)
- Palliative radiation therapy to chest within 3 months or other sites within 14 days before treatment
- Additional malignancy requiring active treatment within 2 years except certain skin or in situ cancers
- Untreated central nervous system metastases or leptomeningeal metastasis
- Prior B7-H4 targeted treatment
- History of cirrhosis, hepatic fibrosis, esophageal or gastric varices, or other significant liver diseases
- Severe uncontrolled systemic disease or intercurrent illness increasing risk of serious adverse events
- Clinically significant cardiovascular disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - Up to approximately 3 years
Participants receive the investigational drug XMT-1660 through an intravenous infusion to assess safety, side effects, and effectiveness against solid tumors.
Trial Site Locations
Total: 26 locations
1
Mayo Clinic Comprehensive Cancer Center
Phoenix, Arizona, United States, 85054
Actively Recruiting
2
UC Irvine Health-Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
Actively Recruiting
3
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94158
Actively Recruiting
4
UCLA David Geffen School of Medicine, Division of Hematology/Oncology
Santa Monica, California, United States, 90404
Actively Recruiting
5
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224
Actively Recruiting
6
Florida Cancer Specialists
Sarasota, Florida, United States, 34232
Actively Recruiting
7
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
8
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
9
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
10
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
11
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
12
Henry Ford Health Hospital
Detroit, Michigan, United States, 48202
Actively Recruiting
13
Mayo Clinic - Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
14
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89169
Actively Recruiting
15
New York University Langone Health
New York, New York, United States, 10016
Actively Recruiting
16
ICHAN School of Medicine at Mount Sinai
New York, New York, United States, 10029
Not Yet Recruiting
17
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
18
Stephenson Cancer Center Oklahoma University Health
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
19
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105
Actively Recruiting
20
Sarah Cannon Research Institute (SCRI)
Nashville, Tennessee, United States, 37203
Actively Recruiting
21
Texas Oncology, P.A.
Dallas, Texas, United States, 75251
Actively Recruiting
22
MD Anderson
Houston, Texas, United States, 77030
Actively Recruiting
23
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Actively Recruiting
24
NEXT Oncology Virginia
Fairfax, Virginia, United States, 22031
Actively Recruiting
25
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 09109
Actively Recruiting
26
Summit Cancer Centers
Spokane, Washington, United States, 99208
Actively Recruiting
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Research Team
C
Caroline Rogalski
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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