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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I am fully active or restricted in physically strenuous activity but can do light work.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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)

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Who is running the clinical trial?

Mersana TherapeuticsLead Sponsor
8 Previous Clinical Trials
1,126 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants still being invited to join this experiment?

"Affirmative. Clinicaltrials.gov affirms that this medical research, which was first advertised on December 1st 2022 is actively looking for individuals to participate. A total of 144 people need to be enrolled from 3 distinct healthcare facilities."

Answered by AI

To what extent does XMT-2056 pose a hazard to human health?

"Because it is still in its first phase of clinical trials, the safety of XMT-2056 has been assessed at level 1. This suggests that there is currently limited knowledge about this drug's efficacy and security."

Answered by AI

How extensive is this research experiment in terms of its participant numbers?

"Affirmative. Clinicaltrials.gov has information that confirms this medical trial is currently recruiting participants, with the original post made on December 1st 2022 and last edited on December 5th 2022. This research necessitates 144 patients from 3 separate locations to complete the study."

Answered by AI

What is the specific goal of this experiment?

"According to the trial sponsor, Mersana Therapeutics, the primary outcome that will be assessed over a 3 year period is Frequency of Dose-Limiting Toxicities (DLTs) associated with XMT-2056 during the first cycle of treatment. As for secondary outcomes, this study aims to measure Objective Response Rate (ORR), Area under Concentration-Time Curve (AUC), and Volume of Distribution."

Answered by AI
~108 spots leftby Apr 2027