High expression of folate receptor alpha in platinum-resistant advanced high-grade ovarian, primary peritoneal, or fallopian tube cancer
Conditions
Interventions
Case series:None
Sponsors
Shanghai Jiao Tong University School of Medicine Affiliated Ruijin Hospital Hainan Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Female patients =18 years old. 2. Histologically confirmed high-grade serous ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. 3. Have received platinum drug therapy in the past and are resistant to platinum drugs (first-line treatment platinum is difficult to rule out, see exclusion criteria 3). 4. The patient must have had disease progression during or after recent anti-cancer treatment. 5. After VENTANA FOLR1 detection, it was confirmed that the FRa expression of the patient's tumor was highly expressed (the proportion of tumor cells with intensity =2+ after FRa staining was required to be =75%). 6. Patients must have at least one evaluable lesion that meets RECIST v1.1 (as determined by investigator imaging). 7. The American Eastern Oncology Consortium Physical Fitness Score (ECOG PS) must be 0-2. 8. Patients must have previously received at least 1 but not more than 3 lines of systemic anticancer therapy, and monotherapy is suitable for the next stage of treatment: a. Neoadjuvant therapy ± adjuvant therapy is considered as 1-line therapy; b. Maintenance therapy (e.g., bevacizumab, PARP inhibitors) is considered as part of the previous treatment line (i.e. not counted separately); c. Changes in treatment due to toxic reactions in the absence of disease progression will be considered as part of the same treatment line (i.e. not counted separately); d. Hormone therapy (except as maintenance therapy) will be considered as a separate line of treatment. 9. Major organ function is normal and patients assessed by investigators as suitable for MIRV treatment are defined as: a) Absolute neutrophil count (ANC) =1.5 × 109/L (1,500µL), and G-CSF has not been used in the past 10 days, or long-acting WBC growth factor has not been used in the past 20 days; b) Platelet count =100×109/L (100,000/µL) without platelet infusion within the previous 10 days; c) Hemoglobin =9.0 g/dL without PRBC infusion within the previous 21 days; d) Serum creatinine =1.5 × normal upper limit (ULN); e) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =3.0×ULN; f) Serum bilirubin =1.5 × ULN (Gilbert syndrome patients with total bilirubin <3.0 × ULN can participate in the study); g) Serum albumin =2 g/dL. 10. All toxic reactions associated with previous treatment (except hair loss) must be restored to CTCAE v5.0=1. 11. Any major surgery that the patient underwent must have been completed at least 4 weeks before the first dose of MIRV, and the postoperative complications from previous surgical treatment have resolved or are stable. 12. The expected survival of the subjects assessed by the investigators was at least 12 weeks. 13. Sign informed consent form.
Exclusion criteria
Exclusion criteria: 1. Participated in other clinical studies during the same period. 2. Patients with endometrioid, clear cell, mucinous, or sarcomatous tissue, mixed tumors containing any of the above histologies, or low-grade/borderline ovarian tumors. 3. Patients with primary platinum-refractory disease, defined as non-response to first-line platinum-containing chemotherapy (i.e., no CR or PR) or disease progression within 3 months of the last first-line platinum-containing treatment. 4. The researcher believes that the patient has other serious systemic diseases (including active infection, non-infectious pulmonary interstitial disease, cardiovascular and cerebrovascular disease of great clinical significance within 6 months before the first administration of the drug) or other reasons and is not suitable for participating in the clinical study. 5. Known prior hypersensitivity to monoclonal antibody therapy or medenin drugs, or to the investigational drug and/or any of its excipients. 6. Patients with active or chronic corneal disease, a history of corneal transplantation, or active eye disease requiring ongoing treatment/monitoring, such as uncontrolled glaucoma, wet age-related macular degeneration requiring intravitreal drug therapy, active diabetic retinopathy with macular edema, macular degeneration, presence of papilledema and/or monocular vision. 7. Patients with pleural effusion, pericardial effusion, or peritoneal effusion that cannot be controlled by drainage or other methods should be excluded, except for small amounts of effusion that are asymptomatic or do not require clinical intervention. 8. Patients who have previously received MIRV or other Fra-targeting drugs. (Prospective cohort limited) 9. Known active central nervous system (CNS) metastases and/or pial metastases. Participants with untreated but asymptomatic BMS, or with radiographic evidence of progression-free status for at least 4 weeks after treatment, who did not require hormonal or antiepileptic therapy for at least 2 weeks, were considered for enrollment. 10. Pregnant or lactating women. Women of childbearing age must consent to a highly effective form of birth control during use of the study drug and for at least seven months after the last dose of MIRV. A woman of reproductive age is a woman who is fertile after menarche until menopause, unless permanently infertile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy. 11. Study participants who used antitumor drugs within 2 weeks prior to initial administration or participated in a clinical study and used investigational drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of = grade 3 investigator-related adverse events (TRAE) as assessed by the investigator; | — |
Secondary
| Measure | Time frame |
|---|---|
| Investigator-assessed ORR: Included the best response to CR or PR as confirmed by RECIST V1.1, and the PR or CR had to last at least 4 weeks to be confirmed.;Investigator-assessed DOR: For patients with objective response, DOR was the time between first meeting CR/PR criteria (whichever occurred first) and the onset of PD or death from any cause (whichever occurred first).;Investigator-assessed PFS: defined as the time between the first dose and the first recorded PD or death from any cause (whichever occurs first) during follow-up for tumor evaluation.;OS: defined as the time between the first dose and death from any cause (for patients who have been lost to follow-up before death, the last follow-up is usually calculated as the time of death).;CA125 Remission: Assessed according to the GCIG (Gynecological Cancer International) assessment criteria.;Incidence, severity, and duration of treatment-stage adverse events (TEAE) and investigational drug-related adverse events (TRAE); | — |
Countries
China
Contacts
Public ContactFeng Weiwei; Zhu Genhai
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine; Hainan Hospital, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Outcome results
None listed