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Monoclonal Antibodies

XMT-2056 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
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
Be older than 18 years old
Must not have
Participant has received prior treatment targeting STING pathway.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

Summary

This trial tests a new drug to treat tumors that express a molecule called HER2.

Who is the study for?
This trial is for people with advanced or recurrent solid tumors that are HER2 positive, who've seen their cancer progress after treatment, can't tolerate current treatments, or have no other beneficial anti-cancer therapies available. Participants need to be in good physical condition (ECOG status 0-1) and have measurable disease. They must provide a fresh tumor biopsy unless medically unfeasible.
What is being tested?
The study is testing XMT-2056 on patients with various types of cancers like breast, gastric, lung, and colorectal cancer that express the HER2 protein. The goal is to see how effective this new drug is on these specific tumors.
What are the potential side effects?
While the specific side effects of XMT-2056 aren't detailed here, common side effects from similar cancer drugs include fatigue, nausea, diarrhea, skin reactions at the injection site and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been treated before for my condition with therapy targeting the STING pathway.

Timeline

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 dose-limiting toxicities (DLTs) associated with XMT-2056 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 of half-life of XMT-2056 (Dose Escalation and Dose Expansion)
Area under the concentration-time curve of XMT-2056 (AUC) (Dose Escalation and Dose Expansion)
Disease control rate (DCR) (Dose Escalation and Dose Expansion)
+8 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: XMT-2056Experimental Treatment1 Intervention
XMT-2056 alone (monotherapy)

Find a Location

Who is running the clinical trial?

Mersana TherapeuticsLead Sponsor
10 Previous Clinical Trials
1,330 Total Patients Enrolled
1 Trials studying Breast Cancer
319 Patients Enrolled for Breast Cancer
Brad Sumrow, MDStudy DirectorMersana Therapeutics
2 Previous Clinical Trials
56 Total Patients Enrolled
Arvin Yang, MD, PhDStudy DirectorMersana Therapeutics
1 Previous Clinical Trials
31 Total Patients Enrolled
~97 spots leftby Apr 2027
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