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.
Study ID
NCT06834672
Phase
PHASE3
Status
Recruiting
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Conditions

  • Fallopian Tube Cancer
  • Ovarian
  • Primary Peritoneal

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • IBI354 — DRUG
    intravenous infusion of 12 mg/kg on Day 1 of each 3-week treatment cycle
  • paclitaxel/Gemcitabine/Liposomal doxorubicin — DRUG
    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

Study Details

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)

Key Dates

First listed
Feb 19, 2025
Start date
Mar 17, 2025
Status verified
Apr 2025
Primary completion
Dec 28, 2027
Completion
Nov 28, 2029

Study Design

Enrollment
450 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental Arm, Control Arm
  • Active Comparator: Control drug

Primary Outcome Measure

To compare the Progression-free survival (PFS) of IBI354 monotherapy versus investigator's choice of chemotherapy [ Time Frame: From date of randomization until the occurrence of first documented progression, death from any cause, or the initiation of new anticancer treatment, whichever occurs first (up to approximately 36 months) ]

Central Contacts

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