NCT06834672 Study of IBI354 Versus Investigator's Choice of Chemotherapy in Patients With Platinum-resistant Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
| NCT ID | NCT06834672 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Innovent Biologics (Suzhou) Co. Ltd. |
| Condition | Ovarian |
| Study Type | INTERVENTIONAL |
| Enrollment | 450 participants |
| Start Date | 2025-03-17 |
| Primary Completion | 2027-12-28 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
This is a multiregional, multicenter, randomized, open-label, phase III study to compare the efficacy, safety, and tolerability of IBI354 monotherapy with investigator's choice of chemotherapy (paclitaxel, gemcitabine, liposomal doxorubicin, or topotecan) in patients with HER2-expressing, platinum-resistant ovarian, primary peritoneal, or fallopian tube cancer. Participants with advanced ovarian, primary peritoneal, fallopian tube cancer who have failed or are intolerant to first-line or more platinum-based chemotherapy will be randomly assigned in a 2:1 ratio to two treatment arms: Experimental Arm: IBI354 monotherapy arm, 12 mg/kg IBI354 on Day 1 of each 3-week cycle; Control Arm: Investigator's choice chemotherapy (paclitaxel, gemcitabine, liposomal doxorubicin, or topotecan)
Eligibility Criteria
Inclusion Criteria 1. Participants have the ability to understand and give written informed consent Form (ICF) for participation in this trial, including all evaluations and procedures as specified by this protocol; 2. Female participants ≥ 18 years old; 3. Expected life time ≥ 12 weeks 4. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1. 5. Histologically or cytologically confirmed locally advanced unresectable or metastatic ovarian, primary peritoneal, or fallopian tube cancer. 6. Must have confirmed disease progression during or after the most recent anticancer therapy. 7. Must have at least 1 measurable target lesion per RECIST v1.1 criteria. 8. Left Ventricular Ejection Fraction (LVEF) ≥ 50% within 28 days prior to the first dose of study drug. 9. Adequate bone marrow and organ function. 10. Female participants of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose of study drug and use effective contracep