OvarianPhase 3NCT06834672
Study of IBI354 Versus Investigator's Choice of Chemotherapy in Patients With Platinum-resistant Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
A Phase 3 study testing IBI354 and paclitaxel/Gemcitabine/Liposomal doxorubicin in people with Ovarian and Primary Peritoneal, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian, Primary Peritoneal, Fallopian Tube Cancer
- What is being tested?
- IBI354 and paclitaxel/Gemcitabine/Liposomal doxorubicin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteChina
- Study dates
- 17 Mar 2025to 28 Nov 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have signed the informed consent form (ICF) and are able to comply with the follow-up visits and related procedures required in the protocol.
- Female subjects, aged ≥ 18 years.
- Life expectancy ≥ 12 weeks.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1.
- Histologically or cytologically confirmed locally advanced unresectable or metastatic ovarian cancer, primary peritoneal cancer, or fallopian tube cancer:
- HER2 expression (IHC1+, IHC2+, IHC 3+) in tumor tissues confirmed by the HER2 expression testing performed by the sponsor's designated central laboratory (hereinafter referred to as the central laboratory).Note: Subjects must provide a sufficient tumor tissue sample for central HER2 assessment.Freshly collected biopsy samples are preferred, and formalin-fixed and paraffin-embedded (FFPE) blocks are preferred.If a newly collected biopsy cannot be provided, the most recent archival sample will be required.If the subjects have previously been confirmed by the central laboratory to have HER2 expression in tumor tissues (IHC1+, IHC2+, IHC 3+), they meet the inclusion criteria and do not need to be retested.
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- Previously received ≥ 1 line of platinum-based chemotherapy and experienced disease progression: If only received 1 line of platinum-based chemotherapy, they must have received at least 4 cycles of platinum-based therapy, have a best response of PR or CR (not required for adjuvant therapy), and have experienced disease progression > 3 months and < 6 months after the last platinum-based chemotherapy; if received 2 or more lines of platinum-based chemotherapy, they must have experienced disease progression during or < 6 months after the last platinum-based chemotherapy.Note: Progressive disease is progressive disease shown by imaging as per RECIST v1.1.
- Patients must have received at least 1 line of prior systemic anti-tumor therapy:
- Adjuvant ± neoadjuvant therapy is considered as 1 line of systemic anti-tumor treatment.
- Maintenance therapy [e.g., bevacizumab, poly adenosine diphosphate-ribose polymerase (PARP) inhibitor] as part of front-line anti-tumor therapy (the number of lines will not be calculated separately).
- For a change in treatment regimen, if the changed treatment drug is the same type of drug as the previous first-line treatment (e.g., platinum, taxane, anthracycline, PARP inhibitor, etc. before and after the change), and there is no disease progression before the change in treatment drug, the changed treatment regimen will be used as part of the number of lines of previous treatment and will not be counted separately.If the changed therapeutic drug is a different type of drug from the previous first-line treatment, or if the drug of the same type is changed after disease progression, the number of lines should be calculated separately.
- If anti-tumor drugs are added to the original treatment regimen for combination therapy (except for maintenance treatment), the number of lines should be calculated separately.
- The number of lines of endocrine therapy will be calculated separately unless administered as a maintenance regimen.
- For subjects with documented positive expression of folate receptor α (FRα) in tumor tissues [using the VENTANA FOLR1 (FOLR-2.1) RxDx assay to assess the percentage of tumor cells with moderate (grade 2) and/or strong (grade 3) membrane staining to the total number of viable tumor cells ≥ 75% based on the "PS2+" scoring method], prior treatment with mirvetuximab soravtansine (MIRV) or an ADC drug with the same target and radiographically confirmed progressive disease as per RECIST v1.1 is required.
- Subjects with documented BRCA mutations (germline and/or somatic) must have received prior treatment with a PARP inhibitor.This study allowed the inclusion of subjects with BRCA mutations identified during the platinum-resistant phase who were PARP inhibitor-naïve.
- Patients must have radiologically confirmed disease progression according to RECIST v1.1 during or after the most recent line of anti-tumor therapy.
- At least 1 measurable target lesion according to RECIST v1.1 [long diameter ≥ 10 mm (short diameter ≥ 15 mm for lymph node lesions) as accurately measured by computed tomography (CT) or magnetic resonance imaging (MRI, with intravenous contrast agent preferred) at baseline, and the lesion is suitable for repeated and accurate measurements].Lesions that have received prior local treatment (e.g., radiotherapy, radioactive seed implantation, and hepatic artery embolization/infusion chemotherapy) can be considered measurable target lesions only if they clearly show PD as per RECIST v1.1].
- Left ventricular ejection fraction (LVEF) ≥ 50% within 28 days prior to the first dose of the investigational drug.
- Adequate bone marrow and organ functions, with laboratory test values meeting the following requirements within 7 days before the first dose of the study drug (If the laboratory tests performed during the screening period do not meet the requirements below, only 1 retest is allowed during the screening period.Any cell/blood component, colony stimulating factor, or cytokine therapy is not allowed within 7 days prior to the hematology test):
- Routine blood test: absolute neutrophil count (ANC) ≥ 1.5 × 109/L or within the normal range; platelet count (PLT) ≥ 90 × 109/L; hemoglobin (HGB) ≥ 90 g/L.
- Liver function: total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); for subjects with Gilbert's syndrome, TBIL ≤ 3 × ULN; for subjects without liver metastasis, AST and ALT ≤ 2.5 × ULN; for subjects with liver metastasis, AST and ALT ≤ 5 × ULN, TBIL ≤ 3 × ULN; albumin (ALB) ≥ 28 g/L.
- Renal function: serum creatinine (Cr) ≤ 1.5 × ULN or creatinine clearance rate (CCR) ≥ 60 mL/min (calculated using the Cockcroft-Gault formula or by measuring the volume of 24-h urine collection); urinalysis indicates urine protein < 2+, and for subjects whose baseline urinalysis indicates urine protein ≥ 2+, 24-h urine collection should be performed and the protein content in 24-h urine should be < 1 g (if both test methods are adopted, the measured value from 24-h urine collection will be used to determine eligibility).
- Coagulation function: International Normalized Ratio (INR) ≤ 1.5; activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.
- For female subjects of childbearing potential, effective contraceptive measures are required throughout the treatment period and 6 months after the treatment period (see Section5.8.1.1).
Who cannot join
- Subjects should not be enrolled in the study if they meet any of the following criteria:
- Histological or cytological examination results meet any of the following conditions:
- Documented sarcoma, mucinous carcinoma, undifferentiated carcinoma, or a combination.
- Demonstrated low-grade or borderline tumors, or both.
- Participation in any other interventional clinical study, except for observational (non-interventional) studies or follow-up period after the end of study treatment in interventional studies.
- Paclitaxel, gemcitabine, liposomal doxorubicin, and topotecan listed in the control arm are not suitable (e.g., all of the above drugs have been previously treated, without any disease response, and with disease progression within 6 months after the last dose).
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- Prior treatment with ADC drugs with a small molecule payload of camptothecin or its derivatives.
- Prior to the first dose of study drug:
- Received systemic treatment such as intravenous infusion of chemotherapy drugs, large molecule targeted drugs, antibody-drug conjugates, immunotherapy, endocrine therapy, or cell therapy within 4 weeks; received local treatment such as intraperitoneal perfusion chemotherapy, tumor embolization, or interventional chemotherapy within 2 weeks.
- Received oral chemotherapy drugs, small molecule targeted drugs, and Chinese herbal medicines indicated for anti-tumor treatment within 2 weeks or 5 half-lives (whichever is longer).
- Radical radiotherapy within 4 weeks; palliative radiotherapy within 2 weeks.
- Treatment with strong inhibitors or inducers of cytochrome P450 3A4 (CYP3A4) within 2 weeks or 5 half-lives (whichever is longer).
- Major surgery (craniotomy, thoracotomy or laparotomy, and other types considered by the investigator to be "major", excluding needle biopsy) within 4 weeks, or presence of significant unhealed wounds, trauma, or ulcers; exploratory laparoscopy within 2 weeks.
- Live(mRNA and non-replicating adenovirus vaccines are not considered live)vaccines within 4 weeks.
- Patients with adverse reactions caused by previous anti-tumor treatments that have not been alleviated to grade 0 or 1 before enrollment according to NCI-CTCAE v5.0 criteria [except for grade 2 alopecia, asthenia, pigmentation, insomnia, peripheral neuropathy, hypomagnesemia, and toxicities stably controlled by medication (such as hypothyroidism stably controlled by replacement therapy, and hypertension stably controlled below 160/100 mmHg after antihypertensive medication).
- Symptomatic central nervous system (CNS) metastasis, spinal cord compression, carcinomatous meningitis, or history of leptomeningeal carcinoma.Subjects with asymptomatic CNS metastases (no neurological symptoms, no need for corticosteroid treatment, and the diameter of metastases is ≤ 1.5 cm) or subjects with brain metastases that are stable after treatment may be considered for inclusion in the study if they meet all of the following criteria: (1) measurable lesions outside the central nervous system; (2) no metastases to midbrain, pons, cerebellum, meninges, medulla oblongata, or spinal cord; (3) stable for at least 4 weeks, without new or enlarging metastases (Clinical symptoms, signs, andRadiologic evidence clearly confirmed); (4) Corticosteroids or anticonvulsants were discontinued at least 2 weeks prior to the first dose of study drug.Central nervous system lesions should be monitored and examined regularly during the study.
- Note:Central nervous system lesions will not be considered target lesions.
- Subjects with pneumonia requiring corticosteroid therapy, or uncontrolled lung diseases (e.g., pulmonary fibrosis, severe radiation pneumonia, and acute lung injury) or suspected to have such diseases by imaging during the screening period.
- Uncontrolled or significant cardiovascular and cerebrovascular diseases, including the following conditions:
- Uncontrolled myocarditis, or symptomatic congestive heart failure Class II-IV (New York Heart Association [NYHA] criteria), symptomatic or uncontrolled arrhythmias such as ventricular tachycardia, atrial fibrillation, ventricular fibrillation, torsades de pointes, etc.
- Fridericia-corrected QT interval (QTcF) >480 ms, personal or family history of congenital long/short QT syndrome.If QTcF is > 480 ms in 1 ECG examination during the screening period, 3 consecutive ECG examinations are required to calculate the mean QTcF value. If QTcF is still > 480 ms, the subject will not be enrolled.
- Before the first dose of study treatmentHistory of any arterial thromboembolic events within 6 months, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack.
- History of deep vein thrombosis, pulmonary embolism, or any other serious thromboembolic event within 3 months prior to first dose of study intervention.Patients who have received anticoagulant therapy for 2 weeks after the discovery of deep vein thrombosis and have stable thrombosis after re-examination, or have a low risk (such as intermuscular venous thrombosis) as assessed by the investigator, are considered to meet the inclusion criteria.
- Uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg) despite of standard treatment.
- Received immunosuppressants within 14 days prior to the first dose of study treatment, excluding intranasal and inhaled corticosteroids, or systemic corticosteroids at doses lower than 10 mg/day of prednisone (or equivalent), or corticosteroids for preventing allergy to contrast media.
- Tumor invades surrounding important tissues and organs, accompanied by obvious clinical symptoms or abnormal organ functions (such as mediastinal great vessels, superior vena cava and inferior vena cava, pericardium, heart, trachea, etc.).
- Bleeding within 3 months prior to the first start of study treatment that is life-threatening, requiring blood transfusion or invasive treatment.
- Symptomatic abdominopelvic effusion requiring intervention (except abdominopelvic effusion caused by tumor as judged by the investigator), pleural effusion, or pericardial effusion (subjects with stably controlled effusion are allowed to be enrolled, defined as no significant increase in effusion under the condition of removing the drainage tube or no drainage, and no clinical symptoms, for at least 7 days).
- Subjects with esophageal or gastric varices requiring immediate intervention (e.g., ligation or sclerotherapy), or who are considered by the investigator or gastroenterology and hepatology experts to be at high risk for bleeding, have evidence of portal hypertension (including splenomegaly from imaging) or have a history of variceal bleeding, must undergo endoscopic assessment within 3 months prior to the first start of study treatment.
- Patients with unhealed gastrointestinal obstruction, perforation, or fistula, or at risk of gastrointestinal obstruction or perforation (including but not limited to acute diverticulitis and abdominal abscess), or with a history of extensive bowel resection (e.g., extensive small bowel resection accompanied by chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic diarrhea.Note: The digestive tract refers to the muscular tube from the oral cavity to the anal canal, including the oral cavity, pharynx, esophagus, stomach, small intestine (duodenum, jejunum, and ileum), large intestine (cecum, appendix, colon, and rectum), and anal canal.
- After tracheal stent implantation; after gastrointestinal stent implantation, the subject did not resume normal diet or defecation.
- Subjects with biliary obstruction, unless the obstruction has been treated locally (e.g., endoscopic stenting or percutaneous transhepatic drainage), and TBIL has decreased to < 1.5 × ULN.
- Hepatic encephalopathy, hepatorenal syndrome, or cirrhosis with Child-Pugh Class B or above.
- Significant malnutrition, such as malnutrition requiring intravenous nutrition.Except for patients who have resumed a normal diet prior to the first study treatment and have discontinued intravenous nutrition.
- Active uncontrolled infection, including the following:
- Infection requiring systemic antibiotic, antiviral, or antifungal therapy.
- Human immunodeficiency virus (HIV) infection (HIV 1/2 Ab positive).
- Acute or chronic active hepatitis B, defined as hepatitis B surface antigen or e antigen positive (any other antibody result) or hepatitis B core antibody positive only (hepatitis B surface antibody negative and hepatitis B e antibody negative), and HBV DNA copy number ≥ 1 × 104Copy number/mL or ≥ 2000 IU/mL; or acute or chronic active hepatitis C, defined as hepatitis C virus (HCV) antibody positive and HCV RNA titer above the lower limit of detection.
- Active tuberculosis infection, or still receiving anti-tuberculosis treatment, or received anti-tuberculosis treatment within 1 year before the first dose of the study drug.
- Complicated with other primary malignancies or other malignancies with active or recurrent risks within 3 years prior to the first dose of study treatment, excluding radically treated basal cell carcinoma of skin, squamous cell carcinoma of skin, radically resected carcinoma in situ, and papillary thyroid carcinoma.
- History of immunodeficiency diseases, including congenital or acquired immunodeficiency diseases.
- History of allogeneic organ transplantation, allogeneic bone marrow transplantation, or autologous hematopoietic stem cell transplantation (except corneal transplantation).
- Allergic to other anti-HER2 antibodies/ADCs, camptothecins and their derivatives, or any component of IBI354.
- Subjects who are pregnant or breastfeeding (may be considered if breastfeeding is discontinued), or subjects who plan to become pregnant.
- Presence of other acute or chronic diseases or laboratory abnormalities that may increase the risk of study participation or drug administration, interfere with the interpretation of study results, or render the subjects unsuitable for participating in the study as judged by the investigator.
- Subject has a neurologic, psychiatric, or social condition that would interfere with trial compliance, significantly increase the risk of adverse events, or prevent the subject from providing written informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site
Affiliated Cancer Hospital of Chongqing University
Chongqing, Chongqing Municipality, 400044
About this study
Official title: 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
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
- Being tested
- IBI354, paclitaxel/Gemcitabine/Liposomal doxorubicin
- Medical subject headings
- Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI354Drug
intravenous infusion of 12 mg/kg on Day 1 of each 3-week treatment cycle
paclitaxel/Gemcitabine/Liposomal doxorubicinDrug
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 Topotecan: 1.25 mg/m2, in 3-week cycles (Q3W), on Days 1, 2, 3, 4, and 5 of each cycle.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | Not described Receives: Drug: IBI354 |
| Control Arm | Active comparator | Not described Receives: Drug: paclitaxel/Gemcitabine/Liposomal doxorubicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: up to approximately 36 months
Numbers of subjects with adverse events
Measured: up to approximately 36 months
CA-125 response rate according to Gynecologic Cancer Intergroup (GCIG) criteria.
Measured: 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
ORR as evaluated per the RECIST v1.1 criteria
Measured: 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
DCR as evaluated per the RECIST v1.1 criteria
Measured: 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)
Duration of Response (DoR) of IBI354 monotherapy versus investigator's choice of chemotherapy
DoR as evaluated per the RECIST v1.1 criteria
Measured: 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)
Time to Response (TTR) of IBI354 monotherapy versus investigator's choice of chemotherapy
TTR as evaluated per the RECIST v1.1 criteria
Measured: 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)
Numbers of subjects with adverse Event of Special Interest
Measured: up to approximately 36 months
Numbers of subjects with Serious Adverse Event (SAE)
Measured: up to approximately 36 months
Evaluate participant's global health status
Evaluate participant's global health status by Quality of Life-5 Dimension-5 Level (EQ-5D-5L)
Measured: up to approximately 36 months
Evaluate participant's cancer-related symptoms and quality of life
Evaluate participant's cancer-related symptoms and quality of life by European by Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire-Core 30 (QLQ-C30)
Measured: up to approximately 36 months
Evaluate the impact of ovarian cancer on participant's physiological, emotional, and social aspects
Evaluate the impact of ovarian cancer on participant's physiological, emotional, and social aspects by EORTC Quality of Life Questionnaire-Ovarian Cancer 28 (QLQ-OV28)
Measured: up to approximately 36 months
Pharmacokinetic (PK) paramenter of IBI354: Plasma concentration (Cmax)
Evaluation of the plasma concentration (Cmax) in subjects treated with IBI354
Measured: up to approximately 36 months
PK paramenter of IBI354: Area under the curve (AUC)
Evaluation of the Area under the curve (AUC) in subjects treated with IBI354
Measured: up to approximately 36 months
PK paramenter of IBI354: Time to maximum concentration (Tmax)
Evaluation of the Time to maximum concentration (Tmax) in subjects treated with IBI354
Measured: up to approximately 36 months
PK paramenter of IBI354: Clearance (CL)
Evaluation of the Clearance (CL) in subjects treated with IBI354
Measured: up to approximately 36 months
PK paramenter of IBI354: Volume of distribution (V)
Evaluation of the Volume of distribution (V) in subjects treated with IBI354
Measured: up to approximately 36 months
PK paramenter of IBI354: Half-life (T1/2)
Evaluation of the Half-life (T1/2) in subjects treated with IBI354
Measured: up to approximately 36 months
Immunogenicity of IBI354: the incidence of anti-drug Antibody(ADA)
The proportion of evaluable subjects (those with both baseline and post-baseline ADA measurements) who tested positive for anti-drug antibodies.
Measured: up to approximately 36 months
Immunogenicity of IBI354: the incidence of Neutralizing Antibody (Nab) (if applicable)
The proportion of evaluable subjects (those with both baseline and post-baseline ADA measurements) who tested positive for neutralizing antibodies.
Measured: up to approximately 36 months
Effect of ADA on safety (if applicable)
Assessment of the potential impact of ADA on safety by comparing the incidence of treatment-emergent adverse events (e.g., TEAEs) between ADA-positive and ADA-negative groups.
Measured: up to approximately 36 months
Effect of ADA on efficacy (if applicable)
Assessment of the potential impact of ADA on drug efficacy by comparing primary efficacy endpoints (e.g., PFS, OS) between ADA-positive and ADA-negative groups.
Measured: up to approximately 36 months
Effect of ADA on PK parameters (if applicable)
Assessment of the potential impact of ADA on the PK parameters of IBI354 between ADA-positive and ADA-negative groups.
Measured: up to approximately 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start17 Mar 2025
- Primary completion28 Dec 2027 (estimated)
- Study completion28 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OvarianStudies of the same condition, open and under way.
- More trials run by Innovent Biologics (Suzhou) Co. Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06834672
- Sponsor's protocol ID
- CIBI354A301
- Status last verified
- Aug 2026
- First submitted
- 5 Feb 2025
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06834672
- Acronym / sponsor ID
- CIBI354A301
- Conditions
- Ovarian, Primary Peritoneal, Fallopian Tube Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Mar 2025 (actual)
- Primary completion
- 28 Dec 2027 (estimated)
- Study completion
- 28 Nov 2029 (estimated)
- First posted
- 19 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Drug: IBI354 |
| Control Arm | Active comparator | Drug: paclitaxel/Gemcitabine/Liposomal doxorubicin |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Have signed the informed consent form (ICF) and are able to comply with the follow-up visits and related procedures required in the protocol.
- Female subjects, aged ≥ 18 years.
- Life expectancy ≥ 12 weeks.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1.
- Histologically or cytologically confirmed locally advanced unresectable or metastatic ovarian cancer, primary peritoneal cancer, or fallopian tube cancer:
Key exclusion criteria (46 listed)
- Histological or cytological examination results meet any of the following conditions:
- Participation in any other interventional clinical study, except for observational (non-interventional) studies or follow-up period after the end of study treatment in interventional studies.
- Paclitaxel, gemcitabine, liposomal doxorubicin, and topotecan listed in the control arm are not suitable (e.g., all of the above drugs have been previously treated, without any disease response, and with disease progression within 6 months after the last dose).
- Prior treatment with ADC drugs with a small molecule payload of camptothecin or its derivatives.
- Prior to the first dose of study drug:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IBI354intravenous infusion of 12 mg/kg on Day 1 of each 3-week treatment cycle | Drug | Experimental Arm |
| paclitaxel/Gemcitabine/Liposomal doxorubicinpaclitaxel：- 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 Topotecan: 1.25 mg/m2, in 3-week cycles (Q3W), on Days 1, 2, 3, 4, and 5 of each cycle. | Drug | Control Arm |
Primary outcome
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)
PFS as evaluated per the RECIST v1.1 criteria
Overall Survival (OS)
Time frame: From date of randomization until the date of death from any cause (up to approximately 48 months)
Overall survival
23 secondary outcomes
Number of subjects with clinically significant changes in physical examination results
Time frame: up to approximately 36 months
Numbers of subjects with adverse events
Time frame: up to approximately 36 months
CA-125 response rate according to Gynecologic Cancer Intergroup (GCIG) criteria.
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)
To compare the objective response rate (ORR) 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)
Disease Control Rate (DCR) 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)
Duration of Response (DoR) 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)
Time to Response (TTR) 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)
Numbers of subjects with adverse Event of Special Interest
Time frame: up to approximately 36 months
Numbers of subjects with Serious Adverse Event (SAE)
Time frame: up to approximately 36 months
Evaluate participant's global health status
Time frame: up to approximately 36 months
Evaluate participant's cancer-related symptoms and quality of life
Time frame: up to approximately 36 months
Evaluate the impact of ovarian cancer on participant's physiological, emotional, and social aspects
Time frame: up to approximately 36 months
Pharmacokinetic (PK) paramenter of IBI354: Plasma concentration (Cmax)
Time frame: up to approximately 36 months
PK paramenter of IBI354: Area under the curve (AUC)
Time frame: up to approximately 36 months
PK paramenter of IBI354: Time to maximum concentration (Tmax)
Time frame: up to approximately 36 months
PK paramenter of IBI354: Clearance (CL)
Time frame: up to approximately 36 months
PK paramenter of IBI354: Volume of distribution (V)
Time frame: up to approximately 36 months
PK paramenter of IBI354: Half-life (T1/2)
Time frame: up to approximately 36 months
Immunogenicity of IBI354: the incidence of anti-drug Antibody(ADA)
Time frame: up to approximately 36 months
Immunogenicity of IBI354: the incidence of Neutralizing Antibody (Nab) (if applicable)
Time frame: up to approximately 36 months
Effect of ADA on safety (if applicable)
Time frame: up to approximately 36 months
Effect of ADA on efficacy (if applicable)
Time frame: up to approximately 36 months
Effect of ADA on PK parameters (if applicable)
Time frame: up to approximately 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing IBI354 and paclitaxel/Gemcitabine/Liposomal doxorubicin in people with Ovarian and Primary Peritoneal, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 46 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.