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RECRUITING
NCT07822646
PHASE3

A Phase 3 Study of Manganese-primed Immunochemotherapy in Patients With Advanced Ovarian Cancer

Sponsor: Chinese PLA General Hospital

View on ClinicalTrials.gov

Summary

Epithelial ovarian cancer is the most lethal gynecologic malignancy, and most patients eventually relapse and develop resistance to available therapies. Immune checkpoint inhibitors have shown limited overall efficacy in recurrent ovarian cancer, partly because of its immunosuppressive tumor microenvironment. Manganese (Mn2+) can activate the cGAS-STING pathway and may enhance antitumor immunity and the therapeutic effects of PD-1 blockade combined with chemotherapy. Following encouraging findings from an early-phase study, a randomized, single-blind, placebo-controlled phase II trial showed that the addition of manganese chloride to anti-PD-1 antibody, nab-paclitaxel, and cisplatin improved clinical outcomes compared with placebo, with an overall manageable safety profile. Based on these findings, this phase III trial is designed to confirm the efficacy and further evaluate the safety of Mn2+-primed immunochemotherapy in patients with advanced ovarian cancer.

Official title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Manganese-primed Immunochemotherapy in Subjects With Advanced Ovarian Cancer

Key Details

Gender

FEMALE

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2026-10-12

Completion Date

2030-12-20

Last Updated

2026-09-16

Healthy Volunteers

No

Conditions

Interventions

DRUG

Manganese Chloride

Administered by inhalation at 0.4mg/kg twice per week in the first 3-week cycle, and then inhaled 0.4mg/kg twice in the first week of each 3-week cycle thereafter

DRUG

Nab-paclitaxel

Administered intravenously, 180-220mg/m2 on day 2 in a 3-week cycle (day 1 without Manganese priming)

DRUG

Platinum chemotherapy

Administered intravenously, Cisplatin (60-80mg/m2) or Carboplatin (area under the curve \[AUC\] 4-6 mg/ mL per min) on day 2 in a 3-week cycle (day 1 without Manganese priming)

DRUG

Anti-PD-1 antibody

Administered intravenously, 200mg on day 3 in a 3-week cycle (day 2 without Manganese priming)

DRUG

Placebo

Administered by inhalation twice per week in the first 3-week cycle, and then inhaled twice in the first week of each 3-week cycle thereafter

Locations (6)

Department of Obstetrics and Gynecology, Seventh Medical Center, Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Department of Bio-therapeutic, First Medical Center, Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Department of Obstetrics and Gynecology, First Medical Center, Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Peking University International Hospital

Beijing, Beijing Municipality, China

Department of Obstetrics and Gynecology, North China University of Science and Technology Affiliated Hospital

Tangshan, Hebei, China

Department of Gynecologic Oncology, Shanxi Province Cancer Hospital

Taiyuan, Shanxi, China