U3-1402 for Metastatic Breast Cancer

Recruiting in Palo Alto (17 mi)

+11 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: SCRI Development Innovations, LLC

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This study is to evaluate safety and efficacy of an antibody drug conjugate U3-1402 (patritumab deruxtecan) in patients with locally advanced or metastatic breast cancer (MBC).

Eligibility Criteria

This trial is for adults with advanced or metastatic breast cancer who have tried certain treatments without success. Eligible patients must not be pregnant, should agree to use two forms of contraception, and cannot have severe heart conditions or active infections like hepatitis or HIV. They also need to have at least one measurable tumor lesion and acceptable organ function.

Inclusion Criteria

You must have at least one measurable tumor according to specific guidelines, except if the cancer has only spread to the bones.

I am using two forms of birth control, including a barrier method, and will continue for 7 months after the last dose.

I had brain metastases treatment over 4 weeks ago, no worsening, mild symptoms, and don't need steroids.

See 10 more

Exclusion Criteria

I don't have any severe side effects from past treatments, except for hair loss.

I do not have active brain or spinal cord complications needing steroids or seizure meds.

I haven't taken chloroquine or hydroxychloroquine in the last 14 days.

See 15 more

Treatment Details

Interventions

U3-1402 (Monoclonal Antibodies)

Trial OverviewThe study tests U3-1402 (patritumab deruxtecan), an antibody drug conjugate, for safety and effectiveness in treating locally advanced or metastatic breast cancer. Participants will receive this experimental medication to see if it helps control their cancer better than current treatments.

Participant Groups

3Treatment groups

Experimental Treatment

Group I: Part ZExperimental Treatment1 Intervention

Participants will receive 5.6 mg/kg U3-1402 (Patritumab Deruxtecan) intravenously on day 1 every 3 weeks. Part Z will enroll an additional 21 participants with HER2+ MBC.

Group II: Part BExperimental Treatment1 Intervention

Participants will receive 5.6 mg/kg U3-1402 intravenously on day 1 every 3 weeks. Part B will enroll 20 participants with metastatic hormone-receptor positive (HR+) HER2-negative cancer and 20 participants with metastatic triple-negative breast cancer (mTNBC), regardless of HER3 expression.

Group III: Part AExperimental Treatment1 Intervention

Participants will receive 5.6 mg/kg U3-1402 (Patritumab Deruxtecan) intravenously on day 1 every 3 weeks. All participants will undergo pre-treatment biopsies. (An archival tissue sample taken within two months of treatment should be provided if it is not medically feasible to provide a pre-treatment biopsy). Up to 60 participants will be enrolled into this arm.