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XMT-2056 for HER2 Low Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
HER2 Low Breast Cancer+5 MoreXMT-2056 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

A Study of XMT-2056 in advanced/recurrent solid tumors that express HER2.

Eligible Conditions
  • HER2 Low Breast Cancer
  • HER2-positive Breast Cancer
  • HER2 Positive Gastric Cancer
  • HER2-positive Colorectal Cancer
  • HER2-positive Non-Small Cell Lung Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

5 Primary · 14 Secondary · Reporting Duration: 3 years

15 months
Frequency of dose-limiting toxicities (DLTs) associated with XMT-2056 during the first cycle of treatment (Dose Escalation)
3 years
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)
Disease control rate (DCR) (Dose Escalation)
Disease control rate (DCR) (Dose Expansion)
Duration of response (DOR) (Dose Escalation and Dose Expansion)
Duration of response (DOR) (Dose Escalation)
Duration of response (DOR) (Dose Expansion)
Incidence of adverse events (Dose Escalation and Dose Expansion)
Maximum observed plasma concentration of XMT-2056 (Cmax) (Dose Escalation and Dose Expansion)
Objective Response Rate (ORR) (Dose Escalation)
Objective Response Rate (ORR) (Dose Expansion)
Serum samples for analysis of XMT-2056 antidrug and antidrug antibodies (ADA) (Dose Escalation and Dose Expansion)
Serum samples for analysis of XMT-2056 antidrug and neutralizing antibodies (ADA/nAb) (Dose Escalation and Dose Expansion)
Systemic clearance of XMT-2056 (Dose Escalation and Dose Expansion)
Time of maximum observed plasma concentration of XMT-2056 (Tmax) (Dose Escalation and Dose Expansion)
Trough concentration of XMT-2056 (Ctrough) (Dose Escalation and Dose Expansion)
Volume of Distribution (Dose Escalation and Dose Expansion)

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
CT-0508
1
SGN-B7H4V
1
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Trial Design

1 Treatment Group

XMT-2056
1 of 1

Experimental Treatment

171 Total Participants · 1 Treatment Group

Primary Treatment: XMT-2056 · No Placebo Group · Phase 1

XMT-2056
Drug
Experimental Group · 1 Intervention: XMT-2056 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 3 years

Who is running the clinical trial?

Mersana TherapeuticsLead Sponsor
8 Previous Clinical Trials
1,330 Total Patients Enrolled
Divya Gupta, MDStudy DirectorMersana Therapeutics
1 Previous Clinical Trials
14 Total Patients Enrolled
Arvin Yang, MD, PhDStudy DirectorMersana Therapeutics
1 Previous Clinical Trials
120 Total Patients Enrolled
Dr. ShinStudy DirectorMersana Therapeutics

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have recurrent or metastatic solid tumors with HER2 expression, and your disease has progressed despite available treatments which are known to confer benefit; OR you cannot tolerate these treatment options; OR the treatments are contraindicated based on an investigator's judgement
Your ECOG performance status is 0 or 1.
Your disease must be measurable according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 guidelines.
You must provide a fresh tumor biopsy tissue sample obtained after the participant's most recent HER2-targeting therapy or an archival tumor tissue sample approved by the study Medical Monitor, unless medically infeasible.
References

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