XMT-2056 for Breast Cancer

Recruiting at 12 trial locations

Overseen By June Buchanan

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Mersana Therapeutics

Must not be taking: Immunosuppressants, STING pathway drugs

Disqualifiers: Untreated CNS metastases, Recent malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

162 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Will I have to stop taking my current medications?

The trial requires that you stop taking immunosuppressive medications at doses greater than 10 mg/day of prednisone (a type of steroid) or equivalent for at least 2 weeks before starting the study treatment. However, physiologic hormone replacement therapy is allowed.

Research Team

Brad Sumrow, MD

Principal Investigator

Mersana Therapeutics

Eligibility Criteria

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.

Inclusion Criteria

My cancer has returned or spread, is HER2 positive, and doesn't respond well to current treatments.

I can provide a recent tumor sample or, if not possible, an older sample with approval.

I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

I am on high-dose immunosuppressants that can't be stopped for the study.

I haven't had active treatment for another cancer, except skin or certain breast/cervix cancers, in the last 2 years.

I have brain metastases but am stable and not on high doses of steroids.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

The dose-finding portion of the study to assess the safety and tolerability of XMT-2056 and determine the maximum tolerated dose (MTD) and/or Recommended Phase 2 Dose (RP2D)

15 months

Dose Expansion

Participants receive XMT-2056 to further assess safety, tolerability, and preliminary anti-tumor effect at the RP2D

3 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 years

Treatment Details

Interventions

• XMT-2056

Trial Overview 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.

Participant Groups

Group I: XMT-2056 Experimental Treatment 1 Intervention

XMT-2056 alone (monotherapy)

XMT-2056 is already approved in United States for the following indications:

Approved in United States as XMT-2056 for:

• Gastric cancer (orphan drug designation)

Who Is Running the Clinical Trial?

Mersana Therapeutics

Lead Sponsor

Trials

11

Recruited

1,500+