Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1
319 participants
INTERVENTIONAL
2022-08-15
2027-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of Intravenous XMT-1001 in Patients With Advanced Solid Tumors
NCT00455052
AMT-253 in Patients With Selected Advanced Solid Tumours
NCT05906862
AMT-116 in Patients With Advanced Solid Tumors
NCT05725291
Subjects With Advanced or Metastatic Solid Tumor Malignancies
NCT05474859
First-in-Human Dose Escalation Study of XMT-1536 in Cancers Likely to Express NaPi2b
NCT06517433
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
XMT-1660
Single arm XMT-1660 alone (monotherapy)
XMT-1660
XMT-1660 will be administered through a vein in your arm or port catheter (intravenously)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
XMT-1660
XMT-1660 will be administered through a vein in your arm or port catheter (intravenously)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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:
1. All participants with TNBC
2. Participants with a history of brain metastases or with neurologic symptoms or signs suspicious for brain metastases.
Exclusion Criteria
* Major surgery within 28 days of starting study treatment, systemic anticancer therapy within the time period of 28 days or 5 half-lives of the prior therapy before starting study treatment (14 days or 5 half-lives for small molecule targeted therapy), whichever is less, or palliative radiation therapy to the chest within 3 months of starting study treatment or to other anatomic sites within 14 days of starting study treatment.
* Diagnosis of additional malignancy that required active treatment (including surgery, systemic therapy, and radiation) within 2 years prior to screening, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or of the cervix.
* Untreated CNS metastases (including new and progressive brain metastases), history of leptomeningeal metastasis or carcinomatous meningitis.
* Prior B7-H4 targeted treatment.
* History of cirrhosis, hepatic fibrosis, esophageal or gastric varices, or other clinically significant liver diseases.
* Current severe, uncontrolled systemic disease (e.g. clinically significant cardiovascular, pulmonary, or metabolic disease) or intercurrent illness that could increase the risk of serious adverse events (SAEs) or interfere with per-protocol evaluations, in the judgment of either the Sponsor or the Investigator.
* Clinically significant cardiovascular disease
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Mersana Therapeutics
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Robert Burger, MD
Role: STUDY_DIRECTOR
Mersana Therapeutics
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Mayo Clinic Comprehensive Cancer Center
Phoenix, Arizona, United States
UC Irvine Health-Chao Family Comprehensive Cancer Center
Orange, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
UCLA
Santa Monica, California, United States
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States
Florida Cancer Specialists
Sarasota, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Henry Ford Health Hospital
Detroit, Michigan, United States
Mayo Clinic - Rochester
Rochester, Minnesota, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
New York University Langone Health
New York, New York, United States
ICHAN School of Medicine at Mount Sinai
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Stephenson Cancer Center Oklahoma University Health
Oklahoma City, Oklahoma, United States
Avera Cancer Institute
Sioux Falls, South Dakota, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, United States
Texas Oncology, P.A.
Dallas, Texas, United States
MD Anderson
Houston, Texas, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
NEXT Oncology Virginia
Fairfax, Virginia, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
Summit Cancer Centers
Spokane, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Felipe Batalini, MD
Role: primary
Ritesh Parajuli
Role: primary
Laura Huppert, MD
Role: primary
Nicholas McAndrew, MD
Role: primary
Pooja Advani, MD
Role: primary
Judy Wang
Role: primary
Hyo Han, MD
Role: primary
Kevin Kalinsky, MD
Role: primary
Patricia Robinson, MD
Role: primary
Gerburg Wulf, MD
Role: primary
Antonio Giordano, MD, PhD
Role: primary
Amy Weise, MD
Role: primary
Roberto Leon-Ferre, MD
Role: primary
Liawaty Ho, MD
Role: primary
Nancy Chan, MD
Role: primary
Amy Tiersten
Role: primary
Nour Abuhadra, MD
Role: primary
Debra Richardson, MD
Role: primary
David C. Starks, MD
Role: primary
Erika P Hamilton, MD
Role: primary
Funda Meric-Bernstam
Role: primary
Kristen Kelley, MD
Role: primary
Alex Spira, MD, PhD
Role: primary
Natasha Hunter, MD
Role: primary
Arvind Chaudhry, MD, PhD
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Toader D, Fessler SP, Collins SD, Conlon PR, Bollu R, Catcott KC, Chin CN, Dirksen A, Du B, Duvall JR, Higgins S, Kozytska MV, Bellovoda K, Faircloth C, Lee D, Li F, Qin L, Routhier C, Shaw P, Stevenson CA, Wang J, Wongthida P, Ter-Ovanesyan E, Ditty E, Bradley SP, Xu L, Yin M, Yurkovetskiy AV, Mosher R, Damelin M, Lowinger TB. Discovery and Preclinical Characterization of XMT-1660, an Optimized B7-H4-Targeted Antibody-Drug Conjugate for the Treatment of Cancer. Mol Cancer Ther. 2023 Sep 5;22(9):999-1012. doi: 10.1158/1535-7163.MCT-22-0786.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MER-XMT-1660-1
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.