A Single-arm Clinical Trial of IMGN853 in Chinese Adult Patients With Platinum-resistant, Epithelial Ovarian Cancer
A Single-arm, Phase III Clinical Trial of IMGN853 in Chinese Adult Patients With Platinum-resistant, Advanced High-grade Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancer With High Expression of Folate Receptor-α
2 other identifiers
interventional
35
1 country
28
Brief Summary
This Phase III single-arm study is to evaluate the efficacy and safety of IMGN853 in Chinese adult patients with platinum-resistant high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancers (hereafter referred to as PROC) with high FRα expression.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Aug 2022
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 18, 2022
CompletedFirst Submitted
Initial submission to the registry
November 14, 2022
CompletedFirst Posted
Study publicly available on registry
November 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedNovember 21, 2022
October 1, 2022
9 months
November 14, 2022
November 14, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective Response Rate (ORR)
Objective response rate (ORR), which includes best response of complete response (CR) or partial response (PR) as assessed by the BIRC.
Up to 2 years
Secondary Outcomes (10)
Duration of response (DOR)
Up to 2 years
ORR assessed by the investigator
Up to 2 years
DOR assessed by the investigator
Up to 2 years
Treatment-emergent adverse events (TEAEs) and Laboratory results,physical examinations, or vital signs
Up to 2 years
Determination of CA-125 response with GCIG criteria
Up to 2 years
- +5 more secondary outcomes
Other Outcomes (1)
Relationship between test results using the companion diagnostic reagent from MEDx Translational Medicine (Suzhou) Co., Ltd. and efficacy of IMGN853 and consistency with VENTANA FOLR1
Up to 2 years
Study Arms (1)
treatment
EXPERIMENTALAll patients will receive single-agent mirvetuximab soravtansine (MIRV) at 6 mg/kg adjusted ideal body weight (AIBW) administered on Day 1 of every 3-week cycle (Q3W).
Interventions
Mirvetuximab Soravtansine is an antibody drug conjugate designed to target folate receptor α (FRα). It consists of the humanized anti-FRα mAb M9346A attached via a cleavable disulfide linker to the cytotoxic maytansinoid, DM4.
Eligibility Criteria
You may qualify if:
- Female patients ≥ 18 years of age
- Patients must have a histopathologically confirmed diagnosis of high-grade serous EOC.
- Patients must have platinum-resistant disease:
- Patients must have had a response (CR or PR) after previous 1 line of platinum-based therapy for at least 4 cycles of treatment, and then progressed between \> 3 months and ≤ 6 months after the date for last dose of platinum.
- Patients who relapsed after \> 6 months since the last platinum-based treatment with at least 4 cycles of one line platinum-based therapy: 1) continued to receive at least 4 cycles of 2 or 3 lines of platinum-based treatment and must have had PD within 6 months from the last dose of platinum; or 2) had PD during treatment with 2 or 3 lines of platinum-containing chemotherapy.
- Note: PD should be calculated from the date of the last dose of platinum-containing therapy to the date of PD indicated by radiographic imaging.
- Patients must have radiological PD on or after the most recent anti-cancer therapy.
- Patients must be willing to provide the archival tumor tissue slides or undergo low-risk routine medical procedures to collect new biopsy samples for immunohistochemistry (IHC) confirmation of FRα positivity.
- Per VENTANA FOLR1 (FOLR-2.1) Assay criteria, patient's tumor must be positive for FRα expression by a central laboratory.
- Patients must have at least one lesion that meets the definition of measurable disease by RECIST v1.1 (radiologically assessed by the investigator).
- Patients must have received at least 1 but no more than 3 lines of prior systemic anti-cancer therapy, including at least 1 line of therapy containing bevacizumab, and for whom monotherapy is appropriate for the next line of treatment:
- Neoadjuvant ± adjuvant is considered as 1 line of therapy;
- Maintenance therapy (eg, bevacizumab, PARP inhibitors) will be considered as part of the prior line of therapy (ie, not counted independently);
- Therapy changed due to toxicity in the absence of PD will be considered as part of the same line (ie, not counted independently);
- Hormonal therapy (except as maintenance therapy) will be considered as a separate line of therapy.
- +18 more criteria
You may not qualify if:
- Male patients.
- Patients with endometrioid carcinoma, clear cell carcinoma, mucinous carcinoma, or sarcoma tissue, mixed tumor containing any of the above histologies, or low grade/borderline ovarian tumor.
- Patients with primary platinum-refractory disease, defined as disease that did not respond to (CR or PR) or has progressed within 3 months of the last dose of first-line platinum-containing chemotherapy.
- Patients who have received prior wide-field radiotherapy (RT) with at least 20% of the bone marrow affected.
- Patients with \> Grade 1 peripheral neuropathy per Common Terminology Criteria for Adverse Events (CTCAE).
- Patients with active or chronic corneal disorders, history of corneal transplant, or active ocular conditions requiring ongoing treatment/monitoring such as uncontrolled glaucoma, wet age-related macular degeneration requiring treatment with intravitreal injections, active diabetic retinopathy with macular edema, macular degeneration, presence of papilloedema, and /or monocular vision.
- Patients with serious concurrent illness or clinically relevant active infection, including, but not limited to the following:
- Known acute or chronic active hepatitis B (HBsAg positive and HBV DNA viral load ≥ 2500 copies/mL or \> 500 IU/mL, if necessary, patients may receive nucleoside prophylactic anti-hepatitis B virus therapy) or acute or chronic active hepatitis C (HCV antibody positive and HCV RNA positive);
- Human immunodeficiency virus (HIV) infection;
- Active cytomegalovirus infection;
- Any other concurrent infectious disease requiring systematic treatment within 2 weeks prior to the first dose of IMGN853.
- Patients with a history of multiple sclerosis (MS) or other demyelinating diseases and/or Lambert-Eaton syndrome (paraneoplastic syndrome).
- Patients with clinically significant cardiac disorders, including but not limited to any of the following:
- Myocardial infarction ≤ 6 months prior to the first dose;
- Unstable angina pectoris;
- +16 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, 233000, China
Anhui Provincial Hospital
Hefei, Anhui, 230000, China
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230000, China
Beijing Obstetrics and Gynecology Hospital, Capital Medical University
Beijing, Beijing Municipality, 100010, China
Fujian Provincial Cancer Hospital
Fuzhou, Fujian, 350000, China
Gansu Provincial Hospital
Lanzhou, Gansu, 730000, China
Sun Yat-Sen University Cancer Hospital
Guangzhou, Guangdong, 510000, China
Affiliated Cancer Hospital of Guangxi Medical University
Nanning, Guangxi, 530015, China
Henan Cancer Hospital
Zhengzhou, Henan, 450000, China
Hubei Cancer Hospital
Wuhan, Hubei, 430000, China
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technolog
Wuhan, Hubei, 430000, China
Zhongnan Hospital Affiliated to Wuhan University
Wuhan, Hubei, 430000, China
Hunan Cancer Hospital
Changsha, Hunan, 410000, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330008, China
Jilin Cancer Hospital
Changchun, Jilin, 130000, China
The Second Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, 116000, China
Liaoning Cancer Hospital
Shengyang, Liaoning, 110084, China
Shandong Cancer Hospital
Jinan, Shandong, 250000, China
Shanghai Tumor Hospital
Shanghai, Shanghai Municipality, 200000, China
SIMC
Shanghai, Shanghai Municipality, 200000, China
People's Hospital of Shanxi province
Xi’an, Shanxi, 710000, China
West China Second Hospital of Sichuan University
Chengdu, Sichuan, 610000, China
Yunnan Cancer Hospital
Kunming, Yunnan, 650000, China
People's Hospital of Zhejiang Province
Hangzhou, Zhejiang, 310000, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000, China
Zhejiang Tumor Hospital
Hangzhou, Zhejiang, 310000, China
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000, China
The Second Affiliated Hospital of Zhengzhou University
Henan, Zhengzhou, 450000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 14, 2022
First Posted
November 21, 2022
Study Start
August 18, 2022
Primary Completion
April 30, 2023
Study Completion
December 31, 2023
Last Updated
November 21, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share