Recruiting
Phase 2

Mirvetuximab Soravtansine

Sponsor:

AbbVie

Code:

NCT06682988

Conditions

Advanced High-Grade Epithelial Ovarian Cancer

Primary Peritoneal Cancer

Fallopian Tube Cancers

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Mirvetuximab Soravtansine

Study Details

Brief summary:

Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess the safety and efficacy of for Mirvetuximab Soravtansine in participants with platinum-resistant advanced high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancer (platinum-resistant ovarian cancer) (PROC) whose tumors express a high level of folate receptor alpha (FRα).

Mirvetuximab Soravtansine (MIRV) is an investigational antibody drug conjugate designed to selectively kill cancer cells. The antibody (protein) part of MIRV targets tumors by delivering a cell-killing drug to cancer cells carrying a protein called folate receptor alpha (FRα). There are 2 cohorts in this study, the Randomized Phase 2 Cohort and the Hepatic Impairment Cohort. In the Randomized Phase 2 Cohort, participants are placed in 1 of 2 groups, called treatment arms. Each treatment arm receives MIRV on a different schedule (on day 1 every 21 days or on days 1 and 15 every 28 days). The Hepatic Impairment Cohort is designed to determine the starting dose of MIRV in patients with moderately abnormal liver function. Around 110 participants will be enrolled in the study at approximately 75 sites worldwide.

The total study duration will be approximately 24 months.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans.

Conditions

Advanced High-Grade Epithelial Ovarian Cancer

Primary Peritoneal Cancer

Fallopian Tube Cancers

Study ID

NCT06682988

Start date

May 28, 2025

Status verified date

May, 2026

Completion date

Apr, 2028

Anticipated

Primary completion date

Jul, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Both Cohorts

  • Participants with a confirmed diagnosis of high-grade serous epithelial ovarian cancer (EOC), primary peritoneal cancer, or fallopian tube cancer.
  • Participants with platinum-resistant disease:

  • Participants with 1 prior line of platinum-based therapy who have received ≥ 4 cycles of platinum and had a response (complete response (CR) or partial response (PR)) followed by radiological progressive disease (PD) between > 3 months and ≤ 6 months after the date of the last dose of platinum.
  • Participants with 2 or 3 prior lines of platinum-based therapy who had radiological PD ≤ 6 months after the date of the last dose of platinum.
  • Participants with progression diagnosed radiographically on or after their most recent line of therapy.
  • Participants with an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
  • Participants with ≥ 1 lesion that meets the definition of measurable disease by RECIST v1.1 (radiologically measured by the investigator).
  • Participants with a tumor that is positive for folate receptor alpha (FRα) expression as determined by the Ventana folate receptor 1 (FOLR1) assay (≥ 75% of tumor staining at 2+ intensity).

Exclusion Criteria:

Both Cohorts

  • Participants with endometrioid, clear cell, mucinous, or sarcomatous histology; mixed tumors containing any of the above histologies; or low-grade or borderline ovarian tumor.
  • Participants with primary platinum-refractory disease, defined as disease that did not respond (complete response (CR) or partial response (PR)) or that progressed radiographically within 3 months of the last dose of first-line platinum-containing chemotherapy.
  • Participants with serious concurrent illness or clinically relevant active infection as outlined in the protocol
  • Participants with a history of hemorrhagic or ischemic stroke within 6 months prior to randomization.

Study Design

Enrollment

110 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Randomized Phase 2 Cohort: Arm A

Participants will receive Mirvetuximab Soravtansine at the standard dose on Day 1 of a 21-day cycle.

experimental: Randomized Phase 2 Cohort: Arm B

Participants will receive Mirvetuximab Soravtansine at a lower dose than the standard dose on Day 1 and Day 15 of a 28-day cycle .

experimental: Hepatic Impairment Cohort : Mirvetuximab Soravtansine

Participants will receive Mirvetuximab Soravtansine on Day 1 of a 21-day cycle. Different doses will be given to groups of patients to identify a safe and effective dose.

Interventions

Mirvetuximab Soravtansine

intravenous (IV) infusion

Primary outcome measure

  • Randomized Phase 2 Cohort: Percentage of Participants with Grade >= 2 Treatment-Emergent Corneal Adverse Events (AEs) [ Time Frame: Up to Approximately 24 months ]
  • Randomized Phase 2 Cohort: Percentage of Participants who Achieved Objective response rate (ORR) [ Time Frame: Up to Approximately 24 months ]
  • Hepatic Impairment Cohort: Maximal Concentration (Cmax) of Mirvetuximab Soravtansine [ Time Frame: Up to Approximately 24 months ]
  • Hepatic Impairment Cohort: Area Under the Plasma Concentration (AUC) of Mirvetuximab Soravtansine [ Time Frame: Up to Approximately 24 months ]
  • Hepatic Impairment Cohort: Trough Concentration (Ctrough) of Mirvetuximab Soravtansine [ Time Frame: Up to Approximately 24 months ]
  • Hepatic Impairment Cohort: Volume of Distribution at Steady State (Vss) of Mirvetuximab Soravtansine [ Time Frame: Up to Approximately 24 months ]
  • Hepatic Impairment Cohort: Time to Maximal Concentration (Tmax) of Mirvetuximab Soravtansine [ Time Frame: Up to Approximately 24 months ]
  • Hepatic Impairment Cohort: Terminal Half-Life (t1/2) of Mirvetuximab Soravtansine [ Time Frame: Up to Approximately 24 months ]

Central Contacts and Locations

Central contacts

ABBVIE CALL CENTER

844-663-3742abbvieclinicaltrials@abbvie.com

Locations

First Physicians Group /ID# 272180

Recruiting

Sarasota, Florida, United States, 34239

St. Elizabeth Medical Center - Edgewood /ID# 272113

Recruiting

Edgewood, Kentucky, United States, 41017

Baptist Health Lexington /ID# 272211

Recruiting

Lexington, Kentucky, United States, 40503

UMass Memorial Medical Center - Belmont Street /ID# 272122

Recruiting

Worcester, Massachusetts, United States, 01605

Karmanos Cancer Institute - Detroit /ID# 272112

Recruiting

Detroit, Michigan, United States, 48201

Allegheny Health Network West Penn Hospital /ID# 272267

Recruiting

Pittsburgh, Pennsylvania, United States, 15244

Memorial Hermann Texas Medical Center /ID# 272227

Recruiting

Houston, Texas, United States, 77030

More Information

Sponsor

AbbVie

Last update posted

May 26, 2026

Last verified

May, 2026

Keywords

  • Advanced High-Grade Epithelial Ovarian
  • Primary Peritoneal
  • Fallopian Tube Cancers
  • High Folate Receptor-Alpha Expression
  • Platinum Resistant
  • Mirvetuximab Soravtansine
  • MIRV
  • IMGN853

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by AbbVie on 2026-05-26.