Trial Title:
A Single-arm Clinical Trial of IMGN853 in Chinese Adult Patients With Platinum-resistant, Epithelial Ovarian Cancer
NCT ID:
NCT05622890
Condition:
Epithelial Ovarian Cancer
Peritoneal Cancer
Fallopian Tube Cancer
Conditions: Official terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Fallopian Tube Neoplasms
Maytansine
Mirvetuximab soravtansine
Conditions: Keywords:
Platinum resistant
Folate-receptor alpha expression
Phase 3
Antibody-drug conjugate
mirvetuximab soravtansine
IMGN853
Epithelial Ovarian Cancer
Peritoneal Cancer
Fallopian Tube Cancer
MIRV
FRα
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Mirvetuximab Soravtansine
Description:
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.
Arm group label:
treatment
Other name:
IMGN853
Other name:
MIRV
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.
Detailed description:
This is 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.
The objective of this study is to determine the efficacy of IMGN853 in platinum-resistant
ovarian cancer (PROC) patients with high folate receptor alpha (FRα) expression.
A total of 35 patients will be enrolled. All patients must have measurable disease (per
Response Evaluation Criteria in Solid Tumors version 1.1, RECIST v1.1) at baseline and be
eligible for receiving IMGN853.
All patients will be treated with the IMGN853 monotherapy with a dose at adjusted ideal
body weight (AIBW) of 6 mg/kg on Day 1 of every 3-week cycle (Q3W).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Female patients ≥ 18 years of age
2. Patients must have a histopathologically confirmed diagnosis of high-grade serous
EOC.
3. Patients must have platinum-resistant disease:
1. 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.
2. 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.
Note: Patients who are platinum-refractory during 1 line treatment are excluded (see
exclusion criterion 3).
4. Patients must have radiological PD on or after the most recent anti-cancer therapy.
5. 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.
6. Per VENTANA FOLR1 (FOLR-2.1) Assay criteria, patient's tumor must be positive for
FRα expression by a central laboratory.
7. Patients must have at least one lesion that meets the definition of measurable
disease by RECIST v1.1 (radiologically assessed by the investigator).
8. 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:
1. Neoadjuvant ± adjuvant is considered as 1 line of therapy;
2. Maintenance therapy (eg, bevacizumab, PARP inhibitors) will be considered as
part of the prior line of therapy (ie, not counted independently);
3. Therapy changed due to toxicity in the absence of PD will be considered as part
of the same line (ie, not counted independently);
4. Hormonal therapy (except as maintenance therapy) will be considered as a
separate line of therapy.
9. Patients must have an Eastern Cooperative Oncology Group Performance Status (ECOG
PS) of 0 or 1.
10. Patients must have completed prior therapy within the following specified times:
1. Systemic anti-tumor therapy (the last prior systemic anti-tumor therapy should
be at least 5 half-lives or 4 weeks from the initiation of the investigational
drug, whichever is shorter);
2. Focal radiotherapy: previous focal radiotherapy should be at least 2 weeks from
the initiation of investigational drug.
11. All toxicities (except alopecia) associated with prior therapy must be stable or
resolved (Grade 1 or normal).
12. Any major surgery that a patient has undergone must have been completed at least 4
weeks prior to the first dose of IMGN853 and the postoperative complications of
prior surgical treatment have resolved or are stable.
13. Patients must have adequate hematologic, hepatic, and renal functions as defined by
the following parameters (without G-CSF [a 20-day drug washout period for
long-acting growth factors], human albumin injection and other corrective treatment
drugs are not allowed within 14 days before obtaining laboratory test values):
1. Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L (1,500 μL);
2. Platelet count ≥ 100 × 10^9/L (100,000/μL) without platelet transfusion in the
prior 10 days;
3. Hemoglobin ≥ 9.0 g/dL without packed red blood cell (PRBC) transfusion in the
prior 21 days;
4. Serum creatinine ≤ 1.5 × upper limit of normal (ULN);
5. Both aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0
× ULN;
6. Serum bilirubin ≤ 1.5 × ULN (patients with Gilbert syndrome may be enrolled if
total bilirubin is < 3.0 × ULN);
7. Serum albumin ≥ 2 g/dL.
14. Patients or their legally authorized representatives must be willing and able to
sign the ICF and comply with the requirements of the protocol.
15. Women of child bearing potential (WCBP), defined as a sexually mature woman who have
not undergone surgical sterilization or who have not been naturally postmenopausal
for at least 12 consecutive months (ie, who have had menses any time in the
preceding 12 consecutive months) must agree to use effective contraceptive methods;
examples included oral, parenteral, or implantable hormonal contraceptive,
intrauterine device, barrier contraceptive with spermicide, partner's latex condom
or vasectomy) while on study treatment and for at least 12 weeks after the last dose
of investigational drug.
16. WCBP must have a negative pregnancy test within 4 days prior to the first dose of
IMGN853.
17. The expected survival of the subject is at least 12 weeks as assessed by the
investigator.
Exclusion Criteria:
1. Male patients.
2. 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.
3. 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.
4. Patients who have received prior wide-field radiotherapy (RT) with at least 20% of
the bone marrow affected.
5. Patients with > Grade 1 peripheral neuropathy per Common Terminology Criteria for
Adverse Events (CTCAE).
6. 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.
7. Patients with serious concurrent illness or clinically relevant active infection,
including, but not limited to the following:
1. 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);
2. Human immunodeficiency virus (HIV) infection;
3. Active cytomegalovirus infection;
4. Any other concurrent infectious disease requiring systematic treatment within 2
weeks prior to the first dose of IMGN853.
8. Patients with a history of multiple sclerosis (MS) or other demyelinating diseases
and/or Lambert-Eaton syndrome (paraneoplastic syndrome).
9. Patients with clinically significant cardiac disorders, including but not limited to
any of the following:
1. Myocardial infarction ≤ 6 months prior to the first dose;
2. Unstable angina pectoris;
3. Uncontrolled congestive cardiac failure (New York Heart Association
classification > II);
4. Uncontrolled ≥ Grade 3 hypertension (per CTCAE criteria);
5. Uncontrolled cardiac arrhythmias.
10. Patients with a history of hemorrhagic or ischemic stroke within 6 months prior to
signing the ICF.
11. Patients with a history of hepatic cirrhosis (Child-Pugh B or C).
12. Patients with a previous clinical diagnosis of or currently ongoing non-infectious
interstitial lung disease (ILD), including noninfectious pneumonitis, lung disorders
such as pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-related
pulmonitis, severely impaired lung function, etc.
13. Patients requiring folic acid-containing supplements (e.g., folate deficiency).
14. Known hypersensitivity to previous monoclonal antibody therapy or maytansinoids, or
to the investigational drug and/or any excipients.
15. Pregnant or lactating women.
16. Patients with prior IMGN853 or other FRα-targeted drug therapies.
17. Known active central nervous system (CNS) and/or leptomeningeal metastases. Patients
with untreated but asymptomatic brain metastases, or patients who have
radiographically documented progression-free status for at least 4 weeks after
treatment and do not require hormonal or antiepileptic therapy for at least 2 weeks
may be considered for enrollment.
18. Patients with a history of other malignancies within 3 years prior to enrollment.
Note: patients with tumors with a negligible risk of metastasis or death (e.g.,
adequately controlled basal-cell carcinoma or squamous-cell carcinoma of the skin,
or carcinoma in situ of the cervix or breast) are eligible for inclusion.
19. Patients with pleural effusion, pericardial effusion, or ascites that cannot be
controlled by drainage or other means, except the small amount of effusion that
without clinical symptoms or do not require clinical intervention.
20. Patients who are detained by a court or administrative decision, receiving
psychiatric care against their will, adults who are under the protection of law
(under tutorship/curatorship), people who are unable to give their consent, and
people who are subject to a legal guardianship.
21. Participated in other clinical studies and received their investigational drugs
within 4 weeks prior to the first dose.
22. Subject has other serious systemic diseases or other reasons that are not suitable
for participation in this clinical study as evaluated by the investigator.
Gender:
Female
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital of Bengbu Medical College
Address:
City:
Bengbu
Zip:
233000
Country:
China
Status:
Recruiting
Contact:
Last name:
Bo Yang, Master
Phone:
+8618155258266
Email:
yangbo2016@163.com
Contact backup:
Last name:
Xiaoli Li, Master
Phone:
+8615215520809
Email:
158169847@qq.com
Facility:
Name:
Anhui Provincial Hospital
Address:
City:
Hefei
Zip:
230000
Country:
China
Status:
Recruiting
Contact:
Last name:
Weidong Zhao, Doctor
Phone:
+8613955105591
Email:
Victorzhao@163.com
Contact backup:
Last name:
Zhengzheng Chen, Doctor
Phone:
+8613865915342
Email:
546038221@99.com
Facility:
Name:
The Second Affiliated Hospital of Anhui Medical University
Address:
City:
Hefei
Zip:
230000
Country:
China
Status:
Recruiting
Contact:
Last name:
Bing Wei, Doctor
Phone:
+8613605696088
Email:
weibing1965@163.com
Contact backup:
Last name:
Runhua He, Doctor
Phone:
+8613676767676
Email:
ayzfyhrh@126.com
Facility:
Name:
Beijing Obstetrics and Gynecology Hospital, Capital Medical University
Address:
City:
Beijing
Zip:
100010
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Xu Sun, Master
Phone:
+8613645153601
Email:
sunxu@eastchinapharm.com
Facility:
Name:
Fujian Provincial Cancer Hospital
Address:
City:
Fuzhou
Zip:
350000
Country:
China
Status:
Recruiting
Contact:
Last name:
Xu Sun, Master
Phone:
+8613645153601
Email:
sunxu@eastchinapharm.com
Facility:
Name:
Gansu Provincial Hospital
Address:
City:
Lanzhou
Zip:
730000
Country:
China
Status:
Recruiting
Contact:
Last name:
Xu Sun, Master
Phone:
+8613645153601
Email:
sunxu@eastchinapharm.com
Facility:
Name:
Sun Yat-Sen University Cancer Hospital
Address:
City:
Guangzhou
Zip:
510000
Country:
China
Status:
Recruiting
Contact:
Last name:
Xu Sun, Master
Phone:
+8613645153601
Email:
sunxu@eastchinapharm.com
Facility:
Name:
Affiliated Cancer Hospital of Guangxi Medical University
Address:
City:
Nanning
Zip:
530015
Country:
China
Status:
Recruiting
Contact:
Last name:
Li Li, Master
Phone:
+8613788889999
Email:
liligxmu2022@163.com
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Zip:
450000
Country:
China
Status:
Recruiting
Contact:
Last name:
Xu Sun, Master
Phone:
+8613645153601
Email:
sunxu@eastchinapharm.com
Facility:
Name:
Hubei Cancer Hospital
Address:
City:
Wuhan
Zip:
430000
Country:
China
Status:
Recruiting
Contact:
Last name:
Xu Sun, Master
Phone:
+8613645153601
Email:
sunxu@eastchinapharm.com
Facility:
Name:
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technolog
Address:
City:
Wuhan
Zip:
430000
Country:
China
Status:
Recruiting
Contact:
Last name:
Xu Sun, Master
Phone:
+8613645153601
Email:
sunxu@eastchinapharm.com
Facility:
Name:
Zhongnan Hospital Affiliated to Wuhan University
Address:
City:
Wuhan
Zip:
430000
Country:
China
Status:
Recruiting
Contact:
Last name:
Hongbing Cai, Doctor
Phone:
+8613397168990
Email:
Chb2105@163.com
Contact backup:
Last name:
Hua Wang, Doctor
Phone:
+86 15871037481
Email:
940983900@qq.com
Facility:
Name:
Hunan Cancer Hospital
Address:
City:
Changsha
Zip:
410000
Country:
China
Status:
Recruiting
Contact:
Last name:
Jing Wang, Doctor
Phone:
+8613875902083
Email:
wangjing@hnca.org.cn
Contact backup:
Last name:
Li Li, Doctor
Phone:
+8615874293489
Email:
lili@hnca.org.cn
Facility:
Name:
The First Affiliated Hospital of Nanchang University
Address:
City:
Nanchang
Zip:
330008
Country:
China
Status:
Recruiting
Contact:
Last name:
Xu Sun, Master
Phone:
+8613645153601
Email:
sunxu@eastchinapharm.com
Facility:
Name:
Jilin Cancer Hospital
Address:
City:
Changchun
Zip:
130000
Country:
China
Status:
Recruiting
Contact:
Last name:
Ying Cheng, Doctor
Phone:
+8613943012851
Email:
jl.cheng@163.com
Contact backup:
Last name:
Hongxia Cui, Doctor
Phone:
+86 13504436090
Email:
2503074283@qq.com
Facility:
Name:
The Second Affiliated Hospital of Dalian Medical University
Address:
City:
Dalian
Zip:
116000
Country:
China
Status:
Recruiting
Contact:
Last name:
Kui Jiang, Master
Phone:
+8617709873696
Email:
JK0411@163.COM
Contact backup:
Last name:
Hongruo Liu, Master
Phone:
+86 17709873397
Email:
liuhongruo@sina.com
Facility:
Name:
Liaoning Cancer Hospital
Address:
City:
Shengyang
Zip:
110084
Country:
China
Status:
Recruiting
Contact:
Last name:
Xu Sun, Master
Phone:
+8613645153601
Email:
sunxu@eastchinapharm.com
Facility:
Name:
Shandong Cancer Hospital
Address:
City:
Jinan
Zip:
250000
Country:
China
Status:
Recruiting
Contact:
Last name:
Qingshui Li, Doctor
Phone:
+8613854158117
Email:
liqingshui64@163.com
Contact backup:
Last name:
Jingwei peng, Doctor
Phone:
+8615688455900
Email:
tudou4212@163.com
Facility:
Name:
Shanghai Tumor Hospital
Address:
City:
Shanghai
Zip:
200000
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaohua Wu, master
Phone:
+86136 0177 2486
Email:
docwuxh@hotmail.com
Contact backup:
Last name:
Yong Wu, master
Phone:
+86 15618369676
Email:
edison-1016@163.com
Facility:
Name:
SIMC
Address:
City:
Shanghai
Zip:
200000
Country:
China
Status:
Recruiting
Contact:
Last name:
Xu Sun, Master
Phone:
+8613645153601
Email:
sunxu@eastchinapharm.com
Facility:
Name:
People's Hospital of Shanxi province
Address:
City:
Xi'an
Zip:
710000
Country:
China
Status:
Recruiting
Contact:
Last name:
Lihong Chen, Master
Phone:
+8615309217015
Email:
lihongchen29@163.com
Contact backup:
Last name:
Echo Li, Doctor
Phone:
+8615229334396
Email:
echo85535063@163.com
Facility:
Name:
West China Second Hospital of Sichuan University
Address:
City:
Chengdu
Zip:
610000
Country:
China
Status:
Recruiting
Contact:
Last name:
Xu Sun, Master
Phone:
+8613645153601
Email:
sunxu@eastchinapharm.com
Facility:
Name:
Yunnan Cancer Hospital
Address:
City:
Kunming
Zip:
650000
Country:
China
Status:
Recruiting
Contact:
Last name:
Xu Sun, Master
Phone:
+8613645153601
Email:
sunxu@eastchinapharm.com
Facility:
Name:
People's Hospital of Zhejiang Province
Address:
City:
Hangzhou
Zip:
310000
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhiquan Qin, Master
Phone:
+8613857123637
Email:
qzq66@126.com
Contact backup:
Last name:
Yun Chen, Doctor
Phone:
+8613858087167
Email:
hlqm1986@163.com
Facility:
Name:
The Second Affiliated Hospital of Zhejiang University School of Medicine
Address:
City:
Hangzhou
Zip:
310000
Country:
China
Status:
Recruiting
Contact:
Last name:
Xuejun Chen, Doctor
Phone:
+8613757119632
Email:
2303011@zju.ed.cn
Contact backup:
Last name:
Jiong Ma, Doctor
Phone:
+8613675875605
Email:
majiong1231@126.com
Facility:
Name:
Zhejiang Tumor Hospital
Address:
City:
Hangzhou
Zip:
310000
Country:
China
Status:
Recruiting
Contact:
Last name:
Aijun Yu, Master
Phone:
+8613857155327
Email:
yaj1993@126.com
Contact backup:
Last name:
Jie Xing, Master
Phone:
+8613758219923
Email:
xingjie@zjcc.org.cn
Facility:
Name:
The Second Affiliated Hospital of Wenzhou Medical University
Address:
City:
Wenzhou
Zip:
325000
Country:
China
Status:
Recruiting
Contact:
Last name:
Yue Hu, Master
Phone:
+8613957790915
Email:
wzhuyue@163.com
Contact backup:
Last name:
Qiong Zhang, Master
Phone:
+8613587605820
Email:
joan_zhang@sina.com
Facility:
Name:
The Second Affiliated Hospital of Zhengzhou University
Address:
City:
Henan
Zip:
450000
Country:
China
Status:
Recruiting
Contact:
Last name:
Xu Sun, Master
Phone:
+8613645153601
Email:
sunxu@eastchinapharm.com
Start date:
August 18, 2022
Completion date:
December 31, 2023
Lead sponsor:
Agency:
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Agency class:
Industry
Source:
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05622890
