Evaluation of Mirvetuximab Soravtansine (IMGN853) in Women With Folate Receptor-α Positive Endometrial Cancer

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Alessandro Santin
Study ID
NCT03832361
Phase
PHASE2
Status
Recruiting

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • IMGN853 — DRUG
    IMGN853 6 mg/kg intravenously every 3 weeks until disease progression

Study Details

The purpose of this study is to evaluate the activity and safety profile of mirvetuximab soravtansine (IMGN853) in patients with type II endometrial cancers that overexpress folate receptor alpha (FRα).

Key Dates

Start date
Jul 15, 2020
Status verified
Jul 2025
Primary completion
Oct 31, 2026
Completion
Oct 31, 2028

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: IMGN853
    IMGN853 administered 6 mg/kg adjusted ideal body weight (AIBW) once every three weeks (Q3W)

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: 5 Years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Smilow Cancer Hospital at Yale New HavenNew HavenConnecticut06510
Alessandro D Santin, M.D.
203-737-4450
Lisa Baker, R.N.
203-785-6398
Alessandro Santin, M.D. (PRINCIPAL_INVESTIGATOR)

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