A Study of SYS6043 in Platinum-Resistant, Advanced Ovarian, Primary Peritoneal, or Fallopian Tube Cancers

NCT07708753 | Not Yet Recruiting Phase 3

• 1 other identifier: SYS6043-004
• Study Type: interventional
• Target: 460
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a randomized, open-label, multicenter Phase III clinical study designed to evaluate the efficacy and safety of SYS6043 versus investigator's choice chemotherapy in participants with platinum-resistant ovarian cancer, primary peritoneal, or fallopian tube cancer.

Conditions

Platinum-resistant Fallopian Tube Cancer; Platinum-resistant Ovarian Cancer; Platinum-resistant Primary Peritoneal Cancer

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival by Blinded Independent Central Review (BICR) based on RECIST v1.1.

  Time from randomization to time of objective radiographic disease progression as assessed by BICR based on RECIST v1.1 or death due to any cause.

  From date of randomization to radiographic disease progression or death due to any cause, up to approximately 16 months.

Secondary Outcomes (13)

• Key secondary endpoint: Overall Survival

  From date of randomization to death due to any cause, up to approximately 39 months.

• ORR by Blinded Independent Central Review (BICR) based on RECIST v1.1.

  up to approximately 24 months.

• DoR by Blinded Independent Central Review (BICR) based on RECIST v1.1.

  up to approximately 24 months.

• DCR by Blinded Independent Central Review (BICR) based on RECIST v1.1.

  up to approximately 24 months.

• PFS by the investigator based on RECIST v1.1.

  up to approximately 24 months.

Study Arms (2)

Experimental Arm

EXPERIMENTAL

Participants will receive SYS6043

Drug: SYS6043

Active Comparator Arm

ACTIVE COMPARATOR

Participants will receive chemotherapy at investigator's discretion

Drug: Liposomal doxorubicin, paclitaxel, or topotecan

Interventions

SYS6043 DRUG

Participants in the experimental group will receive SYS6043, administered on Day 1 of each cycle.

Experimental Arm

Liposomal doxorubicin, paclitaxel, or topotecan DRUG

Participants in the control group will receive investigator's choice chemotherapy: Liposomal doxorubicin 40 mg/m² every 28 days (Q4W), administered on Day 1 of each cycle; Paclitaxel 80 mg/m² every 28 days (Q4W), administered on Days 1, 8, 15, and 22 of each cycle; Topotecan 4 mg/m² every 28 days (Q4W), administered on Days 1, 8, and 15 of each cycle.

Active Comparator Arm

Eligibility Criteria

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

You may qualify if:

• Female participants aged ≥ 18 years (as of the date of signed informed consent).
• Histologically or cytologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer with a histologic subtype of high-grade serous carcinoma or G2-G3 endometrioid carcinoma.
• Participants with prior platinum-based therapy and confirmed platinum-resistant recurrent disease, defined as disease progression or recurrence during platinum-based chemotherapy or within 6 months (183 days) after the last dose of platinum-based chemotherapy. No more than 1 line of systemic therapy following platinum-resistant recurrence, and a total number of treatment lines not exceeding 4 lines.
• At least one evaluable extracranial lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
• Expected survival of the participant is ≥ 3 months.
• ECOG performance status 0-1, with no deterioration in ECOG score within 28 days prior to enrollment.
• LVEF ≥ 50% as demonstrated by ECHO or MUGA obtained within 28 days before enrollment.
• Major organ function must meet the following criteria within 7 days prior to enrollment:
• Complete blood count (no whole blood, red blood cell, or platelet transfusion, and no administration of hematopoietic growth factors \[G-CSF or GM-CSF\], erythropoietin \[EPO\], or thrombopoietin \[TPO\] to correct blood cell counts within 7 days before sampling):i. Absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L;Platelet count (PLT) ≥ 100 × 10\^9/L;Hemoglobin (HGB) ≥ 90 g/L.
• Blood biochemistry:i. Serum creatinine ≤ 1.5 × ULN;Serum total bilirubin (TBIL) ≤ 1.5 × ULN (participants with Gilbert's syndrome may be allowed up to 3 × ULN);Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (≤ 5.0 × ULN for participants with hepatocellular carcinoma or liver metastasis);Serum albumin ≥ 30 g/L.
• \) Coagulation function: i. Activated partial thromboplastin time (APTT) and international normalized ratio (INR) ≤ 1.5 × ULN (for participants not receiving anticoagulation therapy; for those on anticoagulation therapy, levels must be within the therapeutic range with stable dose).
• \. Any toxicities related to prior therapy have resolved to CTCAE version 6.0 grade ≤1 or baseline level, excluding alopecia, fatigue, pigmentation, hypothyroidism stabilized with hormone replacement therapy, grade 2 peripheral neuropathy following chemotherapy, and other toxicities that the investigator deems not to pose a safety risk to participants.
• \. A sufficient washout period from prior anti-tumor therapy is required prior to the first study drug administration.
• \. Willing to provide a previously excised tumor sample or undergo a fresh tumor biopsy for the assessment of B7-H3 expression level (if no contraindications exist).
• \. Female participants of childbearing potential must have a negative serum pregnancy test within 7 days prior to randomization.Female participants of childbearing potential must agree to use highly effective contraception during the study and for at least 7 months after the last dose of study drug.Females must not be breastfeeding during this period.Females must not donate oocytes or undergo oocyte retrieval for personal use during this period.

You may not qualify if:

• Patients with platinum-refractory disease (progression within 1 month after the last platinum-containing therapy).
• Prior treatment with B7H3-targeted therapy.
• Prior treatment with irinotecan, topotecan, any other topoisomerase I inhibitor (including investigational TOP1 inhibitors), or topoisomerase inhibitor-antibody drug conjugate (e.g., trastuzumab deruxtecan, etc.).
• Patients for whom paclitaxel, topotecan, and pegylated liposomal doxorubicin (as listed in the control group) are all considered inappropriate by the investigator.
• History of severe cardiac or cerebrovascular disease, including but not limited to: heart failure ≥ New York Heart Association (NYHA) Class 2; acute coronary syndrome (e.g., myocardial infarction, unstable angina, etc.) within 6 months prior to screening; acute cerebrovascular disease (e.g., transient ischemic attack, cerebral infarction, cerebral hemorrhage, etc.) within 6 months prior to screening.
• Mean corrected QT interval using the Fridericia formula (QTcF) \> 470 milliseconds (ms) based on the results of three 12-lead electrocardiogram (ECG) examinations; history of serious cardiac arrhythmia (e.g., complete left bundle branch block, third-degree atrioventricular block, atrial fibrillation, atrial flutter, ventricular fibrillation, ventricular flutter, etc.), excluding transient atrial fibrillation and atrial flutter.
• Unable or unwilling to discontinue concomitant medications known to prolong the QT interval.
• A history of or current interstitial lung disease (ILD) requiring glucocorticoid treatment, non-infectious interstitial pneumonia, pulmonary fibrosis, and radiation pneumonitis requiring hormone treatment, or suspected of having such diseases by imaging examination at the time of screening.
• A history of underlying lung diseases, including but not limited to pulmonary embolism within 3 months prior to the start of study treatment, severe asthma, severe COPD, restrictive lung disease, and other clinically significant lung damage or requiring supplementary oxygen.
• Patients with active pulmonary tuberculosis (those who have received adequate treatment and stopped anti-tuberculosis treatment for ≥ 3 months before randomization may be enrolled).
• Any autoimmune disease, connective tissue disease, or inflammatory disease involving the lungs that is recorded or suspected at the time of screening (e.g., rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc.).
• Unstable thrombotic events requiring therapeutic intervention within 6 months prior to screening, such as deep vein thrombosis, arterial thrombosis, and pulmonary embolism (patients with stable lower extremity deep vein thrombosis, intermuscular venous thrombosis, or infusion-related thrombosis that are judged to be risk-free by the investigator may be included).
• Presence of uncontrolled infection requiring intravenous antibiotics, antiviral drugs, or antifungal drugs.
• Known human immunodeficiency virus (HIV) infection, or current active syphilis infection (i.e., positive treponema pallidum antibody (RPR or TRUST) or requiring systemic treatment).
• Participants with active viral hepatitis (positive hepatitis B surface antigen and/or positive hepatitis B core antibody with HBV DNA ≥ 10000 copies/ml or 2000 IU/ml; positive hepatitis C virus (HCV) with HCV RNA above the lower limit of detection by the analytical method).

Sponsors & Collaborators

• CSPC Megalith Biopharmaceutical Co.,Ltd.: lead

MeSH Terms

Interventions

liposomal doxorubicin; Paclitaxel; Topotecan

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Camptothecin; Alkaloids; Heterocyclic Compounds

Central Study Contacts

Clinical Trials Information Group officer

CONTACT

031169085587; ctr-contact@cspc.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: randomized, multicenter, open-label clinical trial

Study Record Dates

• First Submitted: June 15, 2026
• First Posted: July 16, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): December 1, 2030
• Last Updated: July 16, 2026

Record last verified: 2026-06