IMMU-132 in TROP-2 Overexpressed Advanced and Relapsed Ovarian Cancer
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18-80
SponsorShanghai Gynecologic Oncology Group
About this trial
To observe the efficacy and safety of IMMU-132 in patients with advanced or recurrent ovarian cancer with high TROP-2 expression in tumor tissue, who have failed standard therapy or are unable to receive standard treatment.
Eligibility criteria
Qualifiers
Age ≥ 18 years and ≤ 80 years;
Histologically confirmed advanced or recurrent high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer;
Disease recurrence or progression after at least three prior platinum-based chemotherapy regimens, with disease progression occurring ≥ 6 months from the last dose of platinum-based chemotherapy, and who are unable to receive standard platinum-based chemotherapy;
Patients with advanced epithelial ovarian cancer presenting with hematogenous metastasis, who are unable to receive standard treatment, with an estimated life expectancy of more than 3 months but approximately not exceeding 12 months with current therapy;
Disqualifiers
Patients who have previously received topoisomerase I inhibitor therapy;
Patients with known hypersensitivity to the study drug, its metabolites, or formulation excipients;
Patients requiring ongoing treatment or prior use of any prohibited medications (e.g., UGT1A1 inhibitors);
Patients with Gilbert's syndrome;
Trial design
Treatments tested in this trial
- Sacituzumab govitecan monotherapy
Treatment groups
19 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov