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

NCT06834672 | Recruiting Phase 3 DMC

• 1 other identifier: CIBI354A301
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Ovarian; Primary Peritoneal; Fallopian Tube Cancer

Outcome Measures

Primary Outcomes (2)

• To compare the Progression-free survival (PFS) of IBI354 monotherapy versus investigator's choice of chemotherapy

  PFS as evaluated per the RECIST v1.1 criteria

  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)

• Overall Survival (OS)

  Overall survival

  From date of randomization until the date of death from any cause (up to approximately 48 months)

Secondary Outcomes (23)

• Number of subjects with clinically significant changes in physical examination results

  up to approximately 36 months

• Numbers of subjects with adverse events

  up to approximately 36 months

• CA-125 response rate according to Gynecologic Cancer Intergroup (GCIG) criteria.

  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)

• To compare the objective response rate (ORR) of IBI354 monotherapy versus investigator's choice of chemotherapy

  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)

• Disease Control Rate (DCR) of IBI354 monotherapy versus investigator's choice of chemotherapy

  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)

Study Arms (2)

Experimental Arm, Control Arm

EXPERIMENTAL

Drug: IBI354

Control drug

ACTIVE COMPARATOR

Drug: paclitaxel/Gemcitabine/Liposomal doxorubicin

Interventions

IBI354 DRUG

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

Experimental Arm, Control Arm

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

Control drug

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants have the ability to understand and give written informed consent Form (ICF) for participation in this trial, including all evaluations and procedures as specified by this protocol;
• Female participants ≥ 18 years old;
• Expected life time ≥ 12 weeks
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
• Histologically or cytologically confirmed locally advanced unresectable or metastatic ovarian, primary peritoneal, or fallopian tube cancer.
• Must have confirmed disease progression during or after the most recent anticancer therapy.
• Must have at least 1 measurable target lesion per RECIST v1.1 criteria.
• Left Ventricular Ejection Fraction (LVEF) ≥ 50% within 28 days prior to the first dose of study drug.
• Adequate bone marrow and organ function.
• Female participants of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose of study drug and use effective contraception throughout the treatment period and for 6 months after the treatment period.

You may not qualify if:

• Patients with histological or cytological findings meet any of the following criteria:
• Endometrioid tumor, clear cell tumor, mucinous tumor, mesenchymal tumor, or contains any of the above components.
• Low-grade or borderline tumor, or contains any of the above components.
• Participation in any other interventional clinical study, except observational (non-interventional) study.
• Paclitaxel, gemcitabine, liposomal doxorubicin, and topotecan listed in the control arm were either ineligible or had previously received and progressed.
• Prior therapy to first dose of study drug:
• Participants who have been treated with Intravenous infusion of chemotherapeutic drugs, macromolecular targeted drugs, immunotherapy, intraperitoneal chemotherapy, tumor embolization or interventional chemotherapy, within 4 weeks.
• Participants who have been treated with oral chemotherapeutic drugs, small molecular targeted drugs, endocrine therapy, and Chinese herbal medicine for anticancer treatment indications, within 2 weeks or 5 half-lives (whichever is longer).
• Participants who have been treated with radical radiotherapy within 4 weeks, palliative radiotherapy within 2 weeks.
• Participants who have been treated with strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers within 2 weeks or 5 half-lives (whichever is longer).
• Participants who have been treated with Major surgery (craniotomy, thoracotomy or laparotomy and other types of surgery considered "major" by the investigator, excluding needle biopsy) within 4 weeks; Laparoscopic exploration surgery within 2 weeks. Or participants have serious non-healing wound, trauma or ulcer.
• Participants who have been treated with live vaccines (mRNA and non-replicating adenovirus vaccines are not considered live vaccines) within 4 weeks.
• Have adverse reactions caused by previous anti-tumor therapy that have not been resolved to Grade 0 or 1 according to NCI-CTCAE v5.0 criteria.
• Presence of symptomatic central nervous system (CNS) metastases, spinal cord compression, carcinomatous meningitis, or history of leptomeningeal carcinoma.
• Participants with pneumonitis requiring corticosteroid treatment, or a history of other clinically significant lung disease.

Sponsors & Collaborators

• Innovent Biologics (Suzhou) Co. Ltd.: lead

Study Sites (1)

Affiliated Cancer Hospital of Chongqing University

Chongqing, Chongqing Municipality, 400044, China

RECRUITING

MeSH Terms

Conditions

Fallopian Tube Neoplasms

Interventions

Paclitaxel

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Fallopian Tube Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Central Study Contacts

Ya Lu

CONTACT

8610-68585566; ya.lu@innoventbio.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: February 19, 2025
• Study Start: March 17, 2025
• Primary Completion (Estimated): December 28, 2027
• Study Completion (Estimated): November 28, 2029
• Last Updated: April 13, 2025

Record last verified: 2025-04

Locations

CN (1)