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A Clinical Study of SYS6041 Combination Therapy for Recurrent Ovarian Cancer

ConditionsOvarian CancerRecurrent Ovarian Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCSPC Megalith Biopharmaceutical Co.,Ltd.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • SYS6041, bevacizumab

    Drug

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

  • SYS6041, carboplatin, bevacizumab

    Drug

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

  • paclitaxel, carboplatin, bevacizumab

    Drug

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

  • SYS6041, enlonstobart, bevacizumab

    Drug

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

Treatment groups

171 Participants
are divided into 4 treatment groups
Group A: SYS6041, bevacizumabExperimental treatment 1 intervention
Group B: SYS6041, carboplatin, bevacizumabExperimental treatment 1 intervention
Group C: paclitaxel, carboplatin, bevacizumabActive comparator 1 intervention
Group D: SYS6041, enlonstobart, bevacizumabExperimental treatment 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

CSPC Megalith Biopharmaceutical Co.,Ltd.

Lead sponsor

Source ClinicalTrials.gov
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