ClinicalTrials.gg
RecruitingNCT07714668Updated Aug 31, 2026

A Clinical Study of SYS6041 Combination Therapy for Recurrent Ovarian Cancer

A Phase 2 interventional study of SYS6041, bevacizumab and SYS6041, carboplatin, bevacizumab in Ovarian Cancer and Recurrent Ovarian Cancer, sponsored by CSPC Megalith Biopharmaceutical Co.,Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-31.

Sponsored by CSPC Megalith Biopharmaceutical Co.,Ltd. (part of CSPC Pharmaceutical Group Limited) · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2026; still recruiting 3 months later.

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Phase
Phase 2
Study type
Interventional
Enrollment
171
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 106 studies testing bevacizumab in Ovarian Neoplasms — 22 open to participants now, 32 under way, 9 of them phase 3. Bevacizumab · Ovarian Neoplasms.

Planned enrollment
27th of 106
171 · median 52
Started
2026
with 5 others
Phase 2
66 of 106
11 open now
Primary completion
2028-04
later than 21 of 31 live
Registered
105th of 106
by date

Among the 106 studies testing bevacizumab in Ovarian Neoplasms, this one is the 27th largest by planned enrollment, is one of 6 that started in 2026, is one of 66 in phase 2, reaches primary completion later than 21 of the 31 other live ones, and was the 105th registered.

Ovarian Neoplasms

3,385 studies on the registry are indexed under Ovarian Neoplasms; 792 are open to participants now.

Browse Ovarian Neoplasms studies →

Open to participants now

22 of the 106 studies testing bevacizumab in Ovarian Neoplasms are open now, in 12 countries. Recruiting first, the newest first:

16 more — sign in →

By country, each count listing its studies:

All 22 open studies →

About bevacizumab

Bevacizumab: first FDA approval 2004 (AVASTIN), first EMA approval 2005. What it is approved for, and how studies give it, is on its page →

Who these studies take

Of the 605 Ovarian Neoplasms studies recruiting now, 442 (73%) set no upper age limit and 107 (18%) stop at 75 or younger; 39 take children under 18; 45 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 106 studies testing bevacizumab in Ovarian Neoplasms, or all of them as a file.
02

Study summary

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.

03

Conditions studied

  • Ovarian Cancer
  • Recurrent Ovarian Cancer

Browse trials for

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Fully understand this clinical trial and voluntarily sign the written form
  2. Age ≥ 18 years old
  3. or cytologically confirmed high-grade serous ovarian, epithelial fallopian tube carcinoma, and primary peritoneal cancer
  4. Cohort A and B:subjects with platinum-sensitive disease who have received ≤2 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
  5. Disease progression or intolerability with the most recent systemic anti-tumor treatment
  6. Adequate organ function with laboratory tests meeting criteria
  7. Have per v1.1
  8. Have an (ECOG) performance status of 0-1.
  9. Expected survival ≥ 3 months
  10. Subjects of (males and females) must agree to use reliable methods with their partner(s) throughout the trial period and for a minimum of 8 months following the last study drug administration

Exclusion criteria

Exclusion Criteria:

  1. Prior treatment with any topoisomerase I inhibitor-loaded ADC therapy
  2. History of other 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)
  3. Subjects with active central nervous system (CNS) manifestations during the screening period, requiring therapy within 28 days prior to the first study drug administration, lesions involving the brainstem, or carcinomatous meningitis.
  4. Adverse reactions from prior anti-tumor therapy have not recovered to 6.0 grade ≤ 1 (except for toxicities such as alopecia that researchers judge to have no safety risk)
  5. Major surgery within 28 days before randomization/first dose, or planned to undergo systemic or local tumor resection during the study period
  6. Subjects who have received strong 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
  7. History of severe gastrointestinal disease
  8. History of severe cardiovascular disease
  9. 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
  10. 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
  11. 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)
  12. Active or , defined as HBsAg positive and HBV DNA > 2000 IU/mL for active hepatitis B; defined as HCV-Ab positive and HCV RNA > for active hepatitis C
  13. History of immunodeficiency or positive antibody test during screening
  14. 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 disease or condition, etc.
Terms in these criteria, in plain language(18)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Reproductive potential

Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.

Criteria about it usually ask for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Brain metastases

Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).

Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

CTCAE grade

The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.

1
Mild.
2
Moderate.
3
Severe.
4
Life-threatening.
5
Death due to the event.

“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.

CYP3A (CYP3A4) inhibitors and inducers

CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.

Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
171 participants (estimated)

Study arms

  • Experimental
    SYS6041, bevacizumab

    Drug: SYS6041, bevacizumab

  • Experimental
    SYS6041, carboplatin, bevacizumab

    Drug: SYS6041, carboplatin, bevacizumab

  • Active comparator
    paclitaxel, carboplatin, bevacizumab

    Drug: paclitaxel, carboplatin, bevacizumab

  • Experimental
    SYS6041, enlonstobart, bevacizumab

    Drug: SYS6041, enlonstobart, bevacizumab

Interventions

  • DrugSYS6041, bevacizumab

    Drug page: Bevacizumab

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

  • DrugSYS6041, carboplatin, bevacizumab

    Drug pages: Carboplatin · Bevacizumab

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

  • Drugpaclitaxel, carboplatin, bevacizumab

    Drug pages: Paclitaxel · Carboplatin · Bevacizumab

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

  • DrugSYS6041, enlonstobart, bevacizumab

    Drug pages: Enlonstobart · Bevacizumab

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

06

What researchers measure

Primary outcomes

  1. The incidence of dose-limiting toxicity (DLT)

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

  2. AEs and SAEs

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

    Time frame: Baseline up to 30 days post last dose

  3. Recommended Phase 2 Dose (RP2D )

    Time frame: Up to approximately 3 years

  4. Objective Response Rate (ORR)

    Time frame: Up to approximately 3 years

Secondary outcomes

  1. Disease control rate (DCR)

    Time frame: Up to approximately 3 years

  2. Duration of Response (DoR)

    Time frame: Up to approximately 3 years

  3. Progression-Free-Survival (PFS)

    Time frame: Up to approximately 3 years

  4. Overall survival (OS)

    Time frame: Up to approximately 3 years

  5. Expression level of tumor markers

    Time frame: Up to approximately 3 years

  6. Maximum Plasma Concentration( Cmax)

    Time frame: Up to approximately 3 years

  7. Time to Maximum Plasma Concentration (Tmax)

    Time frame: Up to approximately 3 years

  8. Area Under the Serum Concentration Time Curve ( AUC)

    Time frame: Up to approximately 3 years

  9. Elimination half-life (t1/2)

    Time frame: Up to approximately 3 years

  10. Anti-Drug Antibody(ADA)

    Time frame: Up to approximately 3 years

07

Study locations

1 of 1 sites recruiting
  • Fudan University Shanghai Cancer Center
    Shanghai, Shanghai Municipality 200032, China
    Recruiting
    • Xiaohua Wu, Ph.D · Contact+86 21-13601772486
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2026 (actual). Primary completion is estimated for Apr 2028, 20 months after the start.

Of 116 industry-sponsored phase 2 interventional studies under Ovarian Neoplasms, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 51. This study's planned 20 months is below that.

Counting every sponsor, half of 344 studies reached it within 47 months; a quarter within 33 and three quarters within 72.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 8, 2026
First posted
Jul 20, 2026
StartActual
Aug 13, 2026
Primary completionEst.
Apr 30, 2028
CompletionEst.
Aug 31, 2029
Last update
Aug 31, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 31, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07714668
Responsible party
Sponsor
First posted
Jul 20, 2026
Start date
Aug 13, 2026
Primary completion
Apr 30, 2028 (estimated)
Completion
Aug 31, 2029 (estimated)
Last update
Aug 31, 2026

Study contacts

Clinical Trials Information Group officer
Contact
ctr-contact@cspc.cn
031169085587
Xiaohua Wu
Contact
wu.xh@fudan.edu.cn
+86 21-13601772486

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Studies of the drugs tested here: Bevacizumab · Carboplatin · Enlonstobart

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