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Epithelial Ovarian CancerPhase 2NCT04983550

Efficacy and Safety of SG001 Combined With PLD in Patients With Platinum-resistant Relapsed EOC

A Phase 2 study testing SG001 and Doxorubicin hydrochloride liposome injection in people with Epithelial Ovarian Cancer and Fallopian Tube Cancer, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd..

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study is a multicenter, randomized, controlled, open-label, phase II study to evaluate the efficacy and safety of SG001 in combination with doxorubicin hydrochloride liposome injection in patients with platinum-resistant relapsed epithelial ovarian cancer. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
What is being tested?
SG001 and Doxorubicin hydrochloride liposome injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
126 participants
Where
No sites listed yet
Study dates
Sep 2021to Jan 2024
Phase
Phase 2
Are there results?
None posted in the registry

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 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female patients aged 18-75 (inclusive) years old (based on the day of signing the informed consent).
  • Histologically or cytologically confirmed epithelial ovarian, fallopian tube, or peritoneal, FIGO stage II-IV (per FIGO 2014).
  • Patients with platinum-resistant relapse (defined as disease progression within 6 months after the last platinum-containing chemotherapy) and non-platinum refractory (defined as disease progression within 4 weeks after the first platinum-containing chemotherapy). Previously received up to three lines of platinum-containing system chemotherapy and up to two lines of platinum-free system chemotherapy.
  • Patients must provide sufficient qualified FFPE tumor tissue specimens or sections for PD-L1 detection.
  • At least one measurable lesion per RECIST 1.1 at baseline. Measurable lesions should not have received local treatment such as radiotherapy (lesions located within previous radiotherapy areas may also be selected as a target lesion if progression is confirmed).
  • Eastern Cooperative Oncology Group (ECOG) physical status score: 0 or 1.
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  • Life expectancy ≥3 months.
  • Vital organ function meets the following requirements (no blood transfusion, no use of hematopoietic stimulating factor, and no use of medication to correct blood cell count within 14 days prior to first administration):
  • Absolute neutrophil count (ANC) ≥ 1.5×10^9/L; B) Platelet count (PLT) ≥ 75×10^9/L; C) Hemoglobin (HGB) ≥ 9 g/dL; D) Serum creatinine Cr ≤ 1.5×ULN or creatinine clearance Ccr ≥ 50 mL/min; E) Total bilirubin (TBil) ≤ 1.5×ULN (3×ULN for patients with Gilbert's syndrome); F) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN (≤ 5×ULN for patients with liver metastasis); G) Activated partial thromboplastin time (APTT) and international standardized ratio (INR) ≤ 1.5×ULN (no correction with anticoagulants or other drug affecting coagulation function within 14 days before the first administration, except long-term anticoagulant therapy is needed.).
  • Toxic and side effects caused by previous anti-tumor therapy should be restored to ≤1 grade (CTCAE 5.0) (except residual alopecia and fatigue) before enrollment.
  • Patients are required to give informed consent to this study and voluntarily sign a written informed consent prior to the study.

Who cannot join

  • A history of severe allergic reaction and uncontrolled allergic asthma to monoclonal antibody preparations.
  • Untreated known CNS metastases, or treated CNS metastases but still with symptoms (except for residual signs or symptoms related to CNS treatment, and those with stable or improved neurological symptoms for at least 2 weeks prior to screening can be enrolled).
  • Patients with a history of primary immunodeficiency.
  • Patients with an active autoimmune disease or a history of autoimmune disease, but with well-controlled type Ⅰ diabetes, well-controlled hypothyroidism requiring only hormone replacement therapy, skin conditions that do not require general treatment (such as vitiligo, psoriasis, or alopecia), or patients whose disease is not expected to recur in the absence of external triggers, will be screened for further enrollment.
  • Baseline cardiac ejection fraction is less than 50% or the lower limit of normal; history of clinically significant prolonged QTc interval (> 450 ms in male, > 470 ms in female); cardiac lesions caused by previous use of anthracyclines; serious cardiovascular disease, such as New York Heart Association (NYHA) grade 2 or higher heart failure, previous myocardial infarction within 3 months, poorly controlled arrhythmias, or unstable angina.
  • Severe arterial/venous thrombosis events (such as transient ischemic attack, cerebral haemorrhage, cerebral infarction, deep venous thrombosis, pulmonary embolism, etc.) within 3 months prior to screening.
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  • Previous interstitial lung disease (except local interstitial pneumonia induced by radiotherapy), non-infectious pneumonia requiring glucocorticoid therapy.
  • Have received any other antibodies/drugs that act on T cell co-stimulation or checkpoint pathways (including PD-1, PD-L1, PD-L2, CTLA-4, OX40, C137 inhibitors, etc.).
  • Patients with immune related AE CTCAE 5.0 grade score ≥ 3 after receiving immunotherapy.
  • Major surgery or radical radiotherapy within 28 days prior to the first administration, or palliative radiotherapy within 14 days prior to the first administration, or radiation agents (strontium, samarium, etc.) within 56 days prior to the first administration.
  • Those who have received systemic antitumor therapy, including but not limited to chemotherapy, immunotherapy, macromolecular targeted therapy, or biotherapy (tumor vaccines, cytokines, or growth factors for cancer control) within 28 days before the first administration of the drug; small molecule targeting and oral fluorouracil-based therapy within 14 days (or 5 half-lives, whichever is longer) prior to first administration; those who had received mitomycin C and nitrosourea within 6 weeks prior to initial administration.
  • Those who received live attenuated vaccine within 28 days before the first administration or who planned to receive it during the study period.
  • Any active infection that requires systemic treatment by intravenous drip within 28 days prior to first administration.
  • Those who have received treatment within 14 days prior to the first dose with a proprietary Chinese medicine that has a clear antitumor-related function in the NMPA-approved drug specification or a Chinese herbal medicine that is clearly documented in the medical record for antitumor purposes.
  • Patients who have received whole or component blood transfusion within 14 days prior to initial administration.
  • Glucocorticoids (prednisone >10 mg/day or equivalent of another similar drug) or other immunosuppressive therapy for a condition within 14 days prior to first administration.
  • Participation in other clinical trials and use of the investigational drug within 28 days prior to the first administration (counting from the date of the last treatment in the previous clinical study) (with the exception of the overall survival follow-up period in one study).
  • Positive for human immunodeficiency virus (HIV-Ab) and treponema pallidum antibody (TP-Ab) antibodies; positive for hepatitis B virus surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb), with HBV quantitative detection value > upper limit of normal value; positive for hepatitis C antibody (HCV-Ab), with hepatitis C virus RNA quantification > upper limit of normal value.
  • History of active tuberculosis.
  • Pregnant or breastfeeding women.
  • Known suffered from other malignant tumors that have progressed or require treatment within 5 years prior to screening (except for well-treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer or cured carcinoma in situ, such as breast carcinoma in situ, etc.).
  • Other circumstances that may increase the risk associated with the study medication, or interfere with the interpretation of the study results, or affect the compliance of the study, etc. may not be suitable for participation in the study as determined by the investigator.
  • Previous use of doxorubicin liposomes.
  • Previous use of other anthracycline/anthraquinone drugs (including non-doxorubicin liposomes) with a converted cumulative dose equivalent to doxorubicin ≥300 mg/m^2, or previous use of anthracyclines causing cardiac disease.

Trial locations and contacts

No sites are listed yet.

Beibei Zhai contact

+86-021-60673937

zhaibeibei@mail.ecspc.cocm

About this study

Official title: A Multicenter, Randomized, Controlled, Open-label, Phase II Study to Evaluate the Efficacy and Safety of SG001 in Combination With PLD in Patients With Platinum-resistant Relapsed Epithelial Ovarian Cancer

This study is a multicenter, randomized, controlled, open-label, phase II study to evaluate the efficacy and safety of SG001 in combination with doxorubicin hydrochloride liposome injection in patients with platinum-resistant relapsed epithelial ovarian cancer.

Read the detailed description

This is a multicenter, randomized, controlled, open-label, phase II clinical study to evaluate the efficacy and safety of SG001 in combination with doxorubicin hydrochloride liposome injection in patients with platinum-resistant relapsed intermediate to advanced epithelial ovarian cancer, and to provide a basis for recommending the SG001 combination dosing regimen for subsequent studies. This study will enroll patients with histologically or cytologically confirmed epithelial ovarian, fallopian tube, or peritoneal cancer, FIGO stage II-IV, platinum-resistant relapse (defined as disease progression within 6 months after the last platinum-containing chemotherapy) and non-platinum refractory (defined as disease progression within 4 weeks after the first platinum-containing chemotherapy) with up to three prior lines of platinum-containing systemic chemotherapy, up to two lines of platinum-free systemic chemotherapy, and at least one measurable tumor lesion (according to RECIST 1.1).

Being tested
SG001, Doxorubicin hydrochloride liposome injection
Medical subject headings
Carcinoma, Ovarian Epithelial, Fallopian Tube Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SG001Drug

    Also called Recombinant Anti-PD-1 Fully Human Monoclonal Antibody Injection

    Recombinant Anti-PD-1 Fully Human Monoclonal Antibody Injection, 240 mg q2w

  • Doxorubicin hydrochloride liposome injectionDrug

    Also called PLD

    Doxorubicin hydrochloride liposome injection 40mg/m ^2 q4w

Study groups in NCT04983550
Study groupRoleWhat they receive
Group A: SG001 + doxorubicin hydrochloride liposome injectionExperimentalTwo-thirds of the patients will be randomly assigned to group A to receive SG001 240 mg, IV, every 2 weeks (1 cycle every 4 weeks), and doxorubicin hydrochloride liposome injection 40 mg/m^2, IV, every 4 weeks (1 cycle).
Receives: Drug: SG001; Drug: Doxorubicin hydrochloride liposome injection
Group B: doxorubicin hydrochloride liposome injectionActive comparatorOne-third of the patients will be randomly assigned to group B to receive doxorubicin hydrochloride liposome injection 40 mg/m^2, IV, every 4 weeks (1 cycle).
Receives: Drug: Doxorubicin hydrochloride liposome injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 1. Objective response rate (ORR, assessed by investigators according to RECIST 1.1 criteria)

    ORR is defined as the proportion of all patients with a best evaluation of complete response or partial response (according to RECIST version 1.1 criteria), from the date of administration to the date of patients' withdrawal or study completion or termination.

    Measured: From date of first drug administration until the first documented progression of disease, patient withdrawal, lose to follow-up, death, initiating a subsequent cancer therapy, or study completion or termination, whichever occurs earliest.

Secondary outcomes (4)

  1. Progression-free survival (PFS)

    PFS measured from the date of administration to the date of investigator firstly assessed disease progression (according to RECIST version 1.1 criteria) or death from any cause (in the absence of progression).

    Measured: From date of first drug administration until the first documented progression of disease, patient withdrawal, lose to follow-up, death, initiating a subsequent cancer therapy, or study completion or termination, whichever occurs earliest,up to 3 years.

  2. Disease control rate (DCR)

    DCR is defined as the proportion of all patients with best a evaluation of complete response or partial response or stable disease (according to RECIST version 1.1 criteria) from the date of administration to the date of patients' withdrawal or study completion or termination.

    Measured: From date of first drug administration until the first documented progression of disease, patient withdrawal, lose to follow-up, death, initiating a subsequent cancer therapy, or study completion or termination, whichever occurs earliest,up to 2 years.

  3. Overall survival (OS)

    OS measured from the date of administration to the date of death from any cause.

    Measured: From date of first drug administration until the first documented progression of disease, patient withdrawal, lose to follow-up, death, initiating a subsequent cancer therapy, or study completion or termination, whichever occurs earliest,up to 3years..

  4. Treatment emergent adverse event (TEAEs)

    Amount, severity, and duration of TEAEs will be evaluated according to NCI-CTCAE V5.0.

    Measured: From the date of signing Informed Consent Form (ICF) up to 28 days following the last dose of study drug, immune related adverse events will be recorded until 90 days after the last dose.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2021
  2. Study startSep 2021 (estimated)
  3. Primary completionJan 2023 (estimated)
  4. Study completionJan 2024 (estimated)

Resources

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
Masking
None (open label)
Enrolment
126 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04983550
Sponsor's protocol ID
SYSA1802-CSP-003
Status last verified
Jul 2021
First submitted
16 Jul 2021
Last updated
30 Jul 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SG001 and Doxorubicin hydrochloride liposome injection in people with Epithelial Ovarian Cancer and Fallopian Tube Cancer, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd..

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 11 inclusion and 24 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: status not confirmed, as of the sponsor's last update on 30 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Beibei Zhai (+86-021-60673937, zhaibeibei@mail.ecspc.cocm), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

1. Objective response rate (ORR, assessed by investigators according to RECIST 1.1 criteria) (time frame: From date of first drug administration until the first documented progression of disease, patient withdrawal, lose to follow-up, death, initiating a subsequent cancer therapy, or study completion or termination, whichever occurs earliest.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04983550.

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 30 Jul 2021.

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