ladiratuzumab vedotin for Triple Negative Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Triple Negative Breast Cancer+4 Moreladiratuzumab vedotin - Drug
Eligibility
18+
Female
What conditions do you have?
Select

Study Summary

This trial will study the safety and effectiveness of a new cancer drug, given alone or with another drug.

Eligible Conditions
  • Triple Negative Breast Cancer
  • HER2-positive Breast Cancer
  • Hormone Receptor Positive Breast Cancer
  • HER2 Positive Breast Cancer
  • Breast Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 7 Secondary · Reporting Duration: Through 3 weeks after dosing; up to approximately 2 years

Year 2
Incidence of adverse events
Incidence of antitherapeutic antibodies
Incidence of laboratory abnormalities
Objective response rate (ORR)
Year 2
Blood concentrations of LV and metabolites
Week 3
Incidence of dose-limiting toxicity (DLT)
Year 3
Duration of response (DOR)
Year 8
Overall survival (OS)
PFS relative to prior therapy
Progression-free survival (PFS)

Trial Safety

Safety Progress

1 of 3

Trial Design

3 Treatment Groups

LV Dose Escalation
1 of 3
LV Monotherapy
1 of 3
LV + Trastuzumab
1 of 3

Experimental Treatment

290 Total Participants · 3 Treatment Groups

Primary Treatment: ladiratuzumab vedotin · No Placebo Group · Phase 1

LV Dose Escalation
Drug
Experimental Group · 1 Intervention: ladiratuzumab vedotin · Intervention Types: Drug
LV Monotherapy
Drug
Experimental Group · 1 Intervention: ladiratuzumab vedotin · Intervention Types: Drug
LV + TrastuzumabExperimental Group · 2 Interventions: Trastuzumab, ladiratuzumab vedotin · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trastuzumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: through 3 weeks after dosing; up to approximately 2 years

Who is running the clinical trial?

Seagen Inc.Lead Sponsor
185 Previous Clinical Trials
61,289 Total Patients Enrolled
Phillip Garfin, MDStudy DirectorSeagen Inc.
Zejing Wang, MD, PhDStudy DirectorSeagen Inc.
2 Previous Clinical Trials
625 Total Patients Enrolled
Kristel Apolinario, PharmDStudy DirectorSeagen Inc.
1 Previous Clinical Trials
211 Total Patients Enrolled
Sinhan Tran, PharmD, MBAStudy DirectorSeagen Inc.
2 Previous Clinical Trials
625 Total Patients Enrolled
Brandon Croft, PharmDStudy DirectorSeagen Inc.
2 Previous Clinical Trials
625 Total Patients Enrolled

Eligibility Criteria

Age 18+ · Female Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have received no prior cytotoxic chemotherapy for unresectable locally advanced or metastatic stage disease.
You have a pathologically confirmed diagnosis of breast cancer with radiographic evidence of LA/MBC.
You have triple negative breast cancer.
Tumor tissue PD-L1 expression CPS <10 expression.
Tumor biopsy must be obtained from a site that is not necessarily surgically accessible.

Who else is applying?

What state do they live in?
New York100.0%
What site did they apply to?
University of California at San Francisco100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
How many prior treatments have patients received?
3+100.0%