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NCT05377996 | RECRUITING | Triple Negative Breast Cancer

A Study of XMT-1660 in Participants With Solid Tumors
Sponsor:

Mersana Therapeutics

Brief Summary:

A Study of XMT-1660 in Solid Tumors

Condition or disease

Triple Negative Breast Cancer

Breast Cancer

Endometrial Cancer

Ovarian Cancer

Fallopian Tube Cancer

Primary Peritoneal Cavity Cancer

Adenoid Cystic Carcinoma

Intervention/treatment

XMT-1660

Phase

PHASE1

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 319 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Phase 1, First-in-human, Dose Escalation and Expansion, Multicenter Study of XMT-1660 in Participants With Solid Tumors
Actual Study Start Date : 2022-08-15
Estimated Primary Completion Date : 2026-12
Estimated Study Completion Date : 2027-05

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * 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
    • 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
    • * Prior treatment with an Antibody Drug Conjugate (ADC) containing an auristatin payload. Prior treatment with another ADC containing other payloads is allowed.
    • * 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
A Study of XMT-1660 in Participants With Solid Tumors

Location Details

NCT05377996

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

UC Irvine Health-Chao Family Comprehensive Cancer Center

Orange, California, United States, 92868

RECRUITING

United States, California

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, United States, 94158

RECRUITING

United States, California

UCLA

Santa Monica, California, United States, 90404

RECRUITING

United States, Florida

Florida Cancer Specialists

Sarasota, Florida, United States, 34232

RECRUITING

United States, Florida

Moffitt Cancer Center

Tampa, Florida, United States, 33612

RECRUITING

United States, Georgia

Winship Cancer Institute, Emory University

Atlanta, Georgia, United States, 30322

RECRUITING

United States, Illinois

Northwestern University

Chicago, Illinois, United States, 60611

RECRUITING

United States, Massachusetts

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

RECRUITING

United States, Massachusetts

Dana-Farber Cancer Institute

Boston, Massachusetts, United States, 02215

RECRUITING

United States, Road cancer

Henry Ford Health Hospital

Detroit, Road cancer, United States, 48202

RECRUITING

United States, Nevada

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, United States, 89169

RECRUITING

United States, New York

New York University Langone Health

New York, New York, United States, 10016

NOT YET RECRUITING

United States, New York

ICHAN School of Medicine at Mount Sinai

New York, New York, United States, 10029

RECRUITING

United States, New York

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065

RECRUITING

United States, Oklahola

Stephenson Cancer Center Oklahoma University Health

Ololama City, Okholohan, United States, 73104

RECRUITING

United States, South Dakota

Avera Cancer Institute

Sioux Falls, South Dakota, United States, 57105

RECRUITING

United States, Tennessee

Tennessee Oncology, PLLC

Nashville, Tennessee, United States, 37203

RECRUITING

United States, Texas

Texas Oncology, P.A.

Dallas, Texas, United States, 75251

RECRUITING

United States, Texas

MD Anderson

Houston, Texas, United States, 77030

RECRUITING

United States, Utah

Huntsman Cancer Institute

Salt Lake City, Utah, United States, 84112

RECRUITING

United States, Virginia

NEXT Oncology Virginia

Fairfax, Virginia, United States, 22031

RECRUITING

United States, Washington

Summit Cancer Centers

Spocane, Washington, United States, 99208