RecruitingPhase 3NCT06834672

Study of IBI354 Versus Investigator's Choice of Chemotherapy in Patients With Platinum-resistant Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

A Multicenter, Randomized, Open-label Phase III Study of IBI354 Versus Investigator's Choice of Chemotherapy in Patients With Platinum-resistant Ovarian, Primary Peritoneal, or Fallopian Tube Cancer


Sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Enrollment

450 participants

Start Date

Mar 17, 2025

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares a new antibody-drug conjugate called IBI354 — which delivers chemotherapy directly into cancer cells — against standard chemotherapy for women with ovarian, fallopian tube, or peritoneal cancer whose disease has continued to grow during or after platinum-based chemotherapy (called platinum-resistant). **You may be eligible if...** - You are a woman aged 18 or older - You have been diagnosed with locally advanced or metastatic ovarian, fallopian tube, or primary peritoneal cancer (confirmed by biopsy) - Your cancer has progressed during or after your most recent treatment - You have at least one measurable tumor on imaging - Your heart function and blood counts are within acceptable ranges - Your expected survival is at least 12 weeks **You may NOT be eligible if...** - Your cancer is not classified as platinum-resistant - You have had more than the permitted number of prior treatments - You have serious heart, lung, or liver problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGIBI354

intravenous infusion of 12 mg/kg on Day 1 of each 3-week treatment cycle

DRUGpaclitaxel/Gemcitabine/Liposomal doxorubicin

paclitaxel:- Usage and dosage: 80 mg/m2 administered as an intravenous infusion on Day 1 of each weekly treatment cycle。 Gemcitabine:Usage and dosage: intravenous infusion at 1000 mg/m2 on Days 1, 8 of each 3-week treatment cycle。 Liposomal doxorubicin:Usage and dosage: intravenous infusion of 40 mg/m2 on Day 1 of each 4-week treatment cycle


Locations(1)

Affiliated Cancer Hospital of Chongqing University

Chongqing, Chongqing Municipality, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06834672


Related Trials