Ovarian CancerPhase 2NCT07714668
A Clinical Study of SYS6041 Combination Therapy for Recurrent Ovarian Cancer
A Phase 2 study testing SYS6041, bevacizumab, SYS6041, carboplatin, bevacizumab and paclitaxel, carboplatin, bevacizumab in people with Ovarian Cancer and Recurrent Ovarian Cancer, run by CSPC Megalith Biopharmaceutical Co.,Ltd. at 1 site in China.
Trial summary
This is an open-label, multicenter Phase II clinical study conducted in subjects with recurrent ovarian cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ovarian Cancer, Recurrent Ovarian Cancer
- What is being tested?
- SYS6041, bevacizumab, SYS6041, carboplatin, bevacizumab and paclitaxel, carboplatin, bevacizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 171 participants
- Where
- 1 siteChina
- Study dates
- 13 Aug 2026to 31 Aug 2029
- Phase
- Phase 2
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Xiaohua Wu, Ph.D, +86 21-13601772486
About this study
Official title: An Open-label , Multicenter, Multicohort, Phase II Clinical Study Evaluating the Efficacy and Safety of SYS6041 Combination Therapy for Recurrent Ovarian Cancer
This is an open-label, multicenter Phase II clinical study conducted in subjects with recurrent ovarian cancer.
Read the detailed description
The study aims to evaluate the safety/tolerability, pharmacokinetics, and preliminary efficacy of SYS6041 in combination with other agents in subjects with recurrent ovarian cancer.
Eligible subjects will receive SYS6041 in combination with different agents (carboplatin, paclitaxel, bevacizumab, enlonstobart) . Each treatment cycle lasting 3 weeks, until disease progression, intolerable toxicity, initiation of new anti-tumor therapy, withdrawal of informed consent, loss to follow-up, or death, whichever occurs first.
- Conditions
- Ovarian Cancer, Recurrent Ovarian Cancer
- Being tested
- SYS6041, bevacizumab, SYS6041, carboplatin, bevacizumab, paclitaxel, carboplatin, bevacizumab, SYS6041, enlonstobart, bevacizumab
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYS6041, bevacizumabDrug
SYS6041: RP2D dose, ivgtt, Q3W Bevacizumab: 15mg/kg, ivgtt, Q3W
SYS6041, carboplatin, bevacizumabDrug
SYS6041: RP2D dose, ivgtt, Q3W Carboplatin: AUC5, ivgtt. Q3W Bevacizumab: 15mg/kg, ivgtt, Q3W
paclitaxel, carboplatin, bevacizumabDrug
Paclitaxel:175mg/m2, ivgtt, Q3W Carboplatin: AUC5, ivgtt. Q3W Bevacizumab: 15mg/kg, ivgtt, Q3W
SYS6041, enlonstobart, bevacizumabDrug
SYS6041: RP2D dose, ivgtt, Q3W Enlonstobart:360mg, ivgtt, Q3W Bevacizumab: 15mg/kg, ivgtt, Q3W
| Study group | Role | What they receive |
|---|---|---|
| SYS6041, bevacizumab | Experimental | Not described Receives: Drug: SYS6041, bevacizumab |
| SYS6041, carboplatin, bevacizumab | Experimental | Not described Receives: Drug: SYS6041, carboplatin, bevacizumab |
| paclitaxel, carboplatin, bevacizumab | Active comparator | Not described Receives: Drug: paclitaxel, carboplatin, bevacizumab |
| SYS6041, enlonstobart, bevacizumab | Experimental | Not described Receives: Drug: SYS6041, enlonstobart, bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of dose-limiting toxicity (DLT)
Measured: 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);
Measured: Baseline up to 30 days post last dose
Recommended Phase 2 Dose (RP2D )
Measured: Up to approximately 3 years
Objective Response Rate (ORR)
Measured: Up to approximately 3 years
Secondary outcomes (10)
Disease control rate (DCR)
Measured: Up to approximately 3 years
Duration of Response (DoR)
Measured: Up to approximately 3 years
Progression-Free-Survival (PFS)
Measured: Up to approximately 3 years
Overall survival (OS)
Measured: Up to approximately 3 years
Expression level of tumor markers
Measured: Up to approximately 3 years
Maximum Plasma Concentration( Cmax)
Measured: Up to approximately 3 years
Time to Maximum Plasma Concentration (Tmax)
Measured: Up to approximately 3 years
Area Under the Serum Concentration Time Curve ( AUC)
Measured: Up to approximately 3 years
Elimination half-life (t1/2)
Measured: Up to approximately 3 years
Anti-Drug Antibody（ADA）
Measured: Up to approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start13 Aug 2026
- Primary completion30 Apr 2028 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by CSPC Megalith Biopharmaceutical 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This trial comprises four study cohorts and aims to evaluate the safety and efficacy of different combination regimens of SYS6041.
- Masking
- None (open label)
- Enrolment
- 171 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07714668
- Sponsor's protocol ID
- SYS6041-002
- Status last verified
- Aug 2026
- First submitted
- 8 Jul 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label , Multicenter, Multicohort, Phase II Clinical Study Evaluating the Efficacy and Safety of SYS6041 Combination Therapy for Recurrent Ovarian Cancer
- ClinicalTrials.gov ID
- NCT07714668
- Acronym / sponsor ID
- SYS6041-002
- Conditions
- Ovarian Cancer, Recurrent Ovarian Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 171 participants (estimated)
- Lead sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Aug 2026 (actual)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 20 Jul 2026 (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 an open-label, multicenter Phase II clinical study conducted in subjects with recurrent ovarian cancer.
Detailed description
The study aims to evaluate the safety/tolerability, pharmacokinetics, and preliminary efficacy of SYS6041 in combination with other agents in subjects with recurrent ovarian cancer.
Eligible subjects will receive SYS6041 in combination with different agents (carboplatin, paclitaxel, bevacizumab, enlonstobart) . Each treatment cycle lasting 3 weeks, until disease progression, intolerable toxicity, initiation of new anti-tumor therapy, withdrawal of informed consent, loss to follow-up, or death, whichever occurs first.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This trial comprises four study cohorts and aims to evaluate the safety and efficacy of different combination regimens of SYS6041.
| Arm | Type | Receives |
|---|---|---|
| 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 | Experimental | Drug: SYS6041, enlonstobart, bevacizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (14 listed)
- 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
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 |
|---|---|---|
| SYS6041, bevacizumabSYS6041: RP2D dose, ivgtt, Q3W Bevacizumab: 15mg/kg, ivgtt, Q3W | Drug | SYS6041, bevacizumab |
| SYS6041, carboplatin, bevacizumabSYS6041: RP2D dose, ivgtt, Q3W Carboplatin: AUC5, ivgtt. Q3W Bevacizumab: 15mg/kg, ivgtt, Q3W | Drug | SYS6041, carboplatin, bevacizumab |
| paclitaxel, carboplatin, bevacizumabPaclitaxel:175mg/m2, ivgtt, Q3W Carboplatin: AUC5, ivgtt. Q3W Bevacizumab: 15mg/kg, ivgtt, Q3W | Drug | paclitaxel, carboplatin, bevacizumab |
| SYS6041, enlonstobart, bevacizumabSYS6041: RP2D dose, ivgtt, Q3W Enlonstobart:360mg, ivgtt, Q3W Bevacizumab: 15mg/kg, ivgtt, Q3W | Drug | SYS6041, enlonstobart, bevacizumab |
Primary outcome
The incidence of dose-limiting toxicity (DLT)
Time frame: At the end of Cycle 1 (each cycle is 21 days)
AEs and SAEs
Time frame: Baseline up to 30 days post last dose
Frequency and severity of AEs and SAEs (according to NCI-CTCAE 6.0);
Recommended Phase 2 Dose (RP2D )
Time frame: Up to approximately 3 years
Objective Response Rate (ORR)
Time frame: Up to approximately 3 years
10 secondary outcomes
Disease control rate (DCR)
Time frame: Up to approximately 3 years
Duration of Response (DoR)
Time frame: Up to approximately 3 years
Progression-Free-Survival (PFS)
Time frame: Up to approximately 3 years
Overall survival (OS)
Time frame: Up to approximately 3 years
Expression level of tumor markers
Time frame: Up to approximately 3 years
Maximum Plasma Concentration( Cmax)
Time frame: Up to approximately 3 years
Time to Maximum Plasma Concentration (Tmax)
Time frame: Up to approximately 3 years
Area Under the Serum Concentration Time Curve ( AUC)
Time frame: Up to approximately 3 years
Elimination half-life (t1/2)
Time frame: Up to approximately 3 years
Anti-Drug Antibody（ADA）
Time frame: Up to approximately 3 years
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 31 Aug 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SYS6041, bevacizumab, SYS6041, carboplatin, bevacizumab and paclitaxel, carboplatin, bevacizumab in people with Ovarian Cancer and Recurrent Ovarian Cancer, run by CSPC Megalith Biopharmaceutical 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 10 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 31 Aug 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Clinical Trials Information Group officer (031169085587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of dose-limiting toxicity (DLT) (time frame: At the end of Cycle 1 (each cycle is 21 days)). The study lists 4 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 31 Aug 2026.