What side effects are associated with this type of intervention?

Common side effects of breast cancer treatments similar to XMT-1660, such as trastuzumab emtansine (T-DM1) and fam-trastuzumab deruxtecan (T-DXd), include decreased neutrophil count, anemia, nausea, and interstitial lung disease. Other frequent adverse events are fatigue, diarrhea, and rash. Serious side effects can include cardiac dysfunction, particularly with trastuzumab-based therapies.

What prior FDA approvals exist?

The FDA has approved several antibody-drug conjugates (ADCs) for the treatment of breast cancer. Notably, ado-trastuzumab emtansine (T-DM1) and fam-trastuzumab deruxtecan (T-DXd) are ADCs that target the HER2 antigen on breast cancer cells. T-DM1 combines trastuzumab with the cytotoxic agent emtansine, while T-DXd links trastuzumab to deruxtecan. These treatments have shown efficacy in patients with HER2-positive metastatic breast cancer, particularly those who have progressed after prior HER2-directed therapies.

What other types of research exist?

Promising novel alternatives to XMT-1660 for breast cancer patients in 2024 include: 1) Trastuzumab Deruxtecan (Enhertu), an antibody-drug conjugate targeting HER2-positive breast cancer. 2) Sacituzumab Govitecan (Trodelvy), an antibody-drug conjugate targeting Trop-2 in triple-negative breast cancer. 3) Pembrolizumab (Keytruda), an immune checkpoint inhibitor for PD-L1 positive breast cancer. 4) Alpelisib (Piqray), a PI3K inhibitor for HR-positive, HER2-negative breast cancer with PIK3CA mutations. These therapies have shown significant efficacy in clinical trials and are considered promising options for breast cancer treatment.

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Monoclonal Antibodies

XMT-1660 for Breast Cancer

Phase 1

Recruiting

Research Sponsored by Mersana Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new drug called XMT-1660 to see if it is safe and what side effects it might have. It focuses on patients whose cancer has come back, spread locally, or spread throughout the body. The study will first find a safe dose and then check if this dose helps treat solid tumors.

Who is the study for?

This trial is for adults with certain advanced solid tumors like ovarian, breast, endometrial, fallopian tube, or peritoneal cancer. They should be in good physical condition (ECOG 0-1), have at least one measurable tumor lesion and agree to a biopsy if safe. Not eligible if they've had another cancer treatment within 2 years (except some skin cancers or localized treatments), severe diseases that could affect the study's process, major surgery or anticancer therapy too close to the start of this study, untreated brain metastases, or prior specific ADC treatments.

What is being tested?

The clinical trial is testing XMT-1660's effectiveness on participants with various types of solid tumors. The main focus is to see how well it works against these cancers and what effects it has on patients' bodies.

What are the potential side effects?

While not specified here, side effects from drugs like XMT-1660 typically include reactions at the injection site, fatigue, nausea and vomiting. There may also be risks associated with organ inflammation and potential impacts on blood cell counts leading to increased infection risk.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Frequency of adverse events that are considered dose-limiting toxicities (DLTs) and associated with XMT-1660 during the first cycle of treatment (Dose Escalation)

Incidence of adverse events (Dose Escalation and Dose Expansion)

Objective Response Rate (ORR) (Dose Expansion)

Secondary study objectives

Apparent terminal elimination half-life of XMT-1660 (Dose Expansion)

Area under the concentration-time curve of XMT-1660 (AUC) (Dose Expansion)

Assess antidrug antibodies (ADA) and neutralizing antibodies (nAB) (Dose Escalation and Dose Expansion)

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: XMT-1660Experimental Treatment1 Intervention

Single arm XMT-1660 alone (monotherapy)

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Antibody-drug conjugates (ADCs) like XMT-1660 are a promising treatment for breast cancer, combining an antibody that targets specific tumor antigens with a cytotoxic drug to deliver treatment directly to cancer cells, minimizing damage to healthy cells. This targeted approach can reduce side effects and improve efficacy. Other common treatments include hormone therapy, which blocks hormones that fuel certain breast cancers, and HER2-targeted therapies, which inhibit the HER2 protein overexpressed in some breast cancers. Chemotherapy and radiation therapy are also used to kill rapidly dividing cells. Understanding these mechanisms helps in creating personalized treatment plans, improving outcomes for breast cancer patients.

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