IMMU-132 in TROP-2 Overexpressed Advanced and Relapsed Ovarian Cancer

ConditionsEpithelial Ovarian Cancer Fallopian Tube Cancers Primary Primary Peritoneal Carcinoma

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

Sacituzumab govitecan monotherapy
Drug
Sacituzumab govitecan monotherapy at a dose of 10 mg/kg administered intravenously on Days 1 and 8 of each 21-day cycle.

Treatment groups

19 Participants

are divided into 1 treatment group

Group A: TROP2-ADC groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Objective response rate

The proportion of patients with complete response (CR) and partial response (PR) assessed by the investigator in accordance with the RECIST 1.1 criteria

Time frame

12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Gynecologic Oncology Group

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: