A Clinical Study of SYS6041 Combination Therapy for Recurrent Ovarian Cancer

NCT07714668 | Not Yet Recruiting Phase 2

• 1 other identifier: SYS6041-002
• Study Type: interventional
• Target: 171
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is an open-label, multicenter Phase II clinical study conducted in subjects with recurrent ovarian cancer.

Conditions

Ovarian Cancer; Recurrent Ovarian Cancer

Outcome Measures

Primary Outcomes (4)

• The incidence of dose-limiting toxicity (DLT)

  At the end of Cycle 1 (each cycle is 21 days)

• AEs and SAEs

  Frequency and severity of AEs and SAEs (according to NCI-CTCAE 6.0);

  Baseline up to 30 days post last dose

• Recommended Phase 2 Dose (RP2D )

  Up to approximately 3 years

• Objective Response Rate (ORR)

  Up to approximately 3 years

Secondary Outcomes (10)

• Disease control rate (DCR)

  Up to approximately 3 years

• Duration of Response (DoR)

  Up to approximately 3 years

• Progression-Free-Survival (PFS)

  Up to approximately 3 years

• Overall survival (OS)

  Up to approximately 3 years

• Expression level of tumor markers

  Up to approximately 3 years

Study Arms (4)

SYS6041, bevacizumab

EXPERIMENTAL

Drug: SYS6041, bevacizumab

SYS6041, carboplatin, bevacizumab

EXPERIMENTAL

Drug: SYS6041, carboplatin, bevacizumab

paclitaxel, carboplatin, bevacizumab

ACTIVE COMPARATOR

Drug: paclitaxel, carboplatin, bevacizumab

SYS6041, enlonstobart, bevacizumab

ACTIVE COMPARATOR

Drug: SYS6041, enlonstobart, bevacizumab

Interventions

SYS6041, bevacizumab DRUG

SYS6041: RP2D dose, ivgtt, Q3W Bevacizumab: 15mg/kg, ivgtt, Q3W

SYS6041, bevacizumab

SYS6041, carboplatin, bevacizumab DRUG

SYS6041: RP2D dose, ivgtt, Q3W Carboplatin: AUC5, ivgtt. Q3W Bevacizumab: 15mg/kg, ivgtt, Q3W

SYS6041, carboplatin, bevacizumab

SYS6041, enlonstobart, bevacizumab DRUG

SYS6041: RP2D dose, ivgtt, Q3W Enlonstobart:360mg, ivgtt, Q3W Bevacizumab: 15mg/kg, ivgtt, Q3W

SYS6041, enlonstobart, bevacizumab

paclitaxel, carboplatin, bevacizumab DRUG

Paclitaxel:175mg/m2, ivgtt, Q3W Carboplatin: AUC5, ivgtt. Q3W Bevacizumab: 15mg/kg, ivgtt, Q3W

paclitaxel, carboplatin, bevacizumab

Eligibility Criteria

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

You may qualify if:

• Fully understand this clinical trial and voluntarily sign the written informed consent form
• Age ≥ 18 years old
• Histologically or cytologically confirmed high-grade serous ovarian, epithelial fallopian tube carcinoma, and primary peritoneal cancer
• Cohort A and B：subjects with platinum-sensitive disease who have received ≤2 prior lines of systemic chemotherapy and if have a BRCAm or HRD-positive status must have recieved PARP inhibitor maintenance therapy; Cohort C: subjects with platinum-resistant disease who have received ≤3 prior lines of systemic chemotherapy
• Disease progression or intolerability with the most recent systemic anti-tumor treatment
• Adequate organ function with laboratory tests meeting criteria
• Have measurable disease per RECIST v1.1
• Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• Expected survival ≥ 3 months
• Subjects of reproductive potential (males and females) must agree to use reliable contraceptive methods with their partner(s) throughout the trial period and for a minimum of 8 months following the last study drug administration

You may not qualify if:

• Prior treatment with any topoisomerase I inhibitor-loaded ADC therapy
• History of other malignancies within 3 years before randomization/first dose or concurrent active malignancies (except cured localized tumors such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, carcinoma in situ of the cervix, carcinoma in situ of the breast, etc., which are allowed to enroll)
• Subjects with active central nervous system (CNS) manifestations during the screening period, CNS metastases requiring corticosteroid therapy within 28 days prior to the first study drug administration, lesions involving the brainstem, or carcinomatous meningitis.
• Adverse reactions from prior anti-tumor therapy have not recovered to CTCAE 6.0 grade ≤ 1 (except for toxicities such as alopecia that researchers judge to have no safety risk)
• Major surgery within 28 days before randomization/first dose, or planned to undergo systemic or local tumor resection during the study period
• Subjects requiring folic acid supplementation during the screening period
• Subjects who have received strong CYP3A4 inhibitors or strong CYP3A4 inducers within 14 days prior to randomization/first study drug administration, or who require continuous systemic administration of such agents during the study treatment period
• History of severe gastrointestinal disease
• History of severe cardiovascular disease
• Uncontrolled serous effusions (e.g., pleural effusion, ascites, pericardial effusion) that necessitate frequent drainage or medical intervention within 14 days before randomization/first dose, or requirement for further intervention within 2 weeks after a previous intervention
• Subjects with a history of interstitial lung disease (ILD) or non-infectious pneumonia, current non-infectious pneumonia requiring corticosteroid treatment, or suspected ILD/non-infectious pneumonia identified at screening
• Active bacterial, fungal or viral infection within 14 days before randomization/first dose (defined as requiring intravenous anti-bacterial, anti-fungal or anti-viral drug therapy)
• Active hepatitis B or hepatitis C, defined as HBsAg positive and HBV DNA \> 2000 IU/mL for active hepatitis B; defined as HCV-Ab positive and HCV RNA \> ULN for active hepatitis C
• History of immunodeficiency or positive HIV antibody test during screening
• Presence of other conditions that may interfere with participants' participation in study procedures, not in line with participants' maximum benefit from participating in the study, or affect study results: such as history of mental illness, drug abuse or substance abuse, any other clinically significant disease or condition, etc.

Sponsors & Collaborators

• CSPC Megalith Biopharmaceutical Co.,Ltd.: lead

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Bevacizumab; Carboplatin; Paclitaxel

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Central Study Contacts

Clinical Trials Information Group officer

CONTACT

031169085587; ctr-contact@cspc.cn

Xiaohua Wu

CONTACT

+86 21-13601772486; wu.xh@fudan.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This trial comprises four study cohorts and aims to evaluate the safety and efficacy of different combination regimens of SYS6041.

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: July 20, 2026
• Study Start (Estimated): August 31, 2026
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): August 31, 2029
• Last Updated: July 20, 2026

Record last verified: 2026-07