A Single-arm Clinical Trial of IMGN853 in Chinese Adult Patients With Platinum-resistant, Epithelial Ovarian Cancer

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.