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Advanced Malignant Perivascular Epithelioid Cell Tumor (PEComa)Phase 1/2NCT05625919

A Study of Safety and Efficacy of Sirolimus for Injection (Albumin-bound) in Patients With Advanced Malignant Perivascular Epithelioid Cell Tumor (PEComa)

A Phase 1/2 study testing Sirolimus for Injection (Albumin Bound) in people with Advanced Malignant Perivascular Epithelioid Cell Tumor (PEComa), run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.

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 The sponsor has not verified this record for over two years, so it may be out of date.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 is a phase Ⅰb/Ⅱ multi-center study of safety and efficacy of Sirolimus for Injection (Albumin-bound) in patients with advanced malignant perivascular epithelioid cell tumor (PEComa). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Sirolimus for Injection (Albumin Bound)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 siteChina
Study dates
8 Nov 2022to Nov 2024
Phase
Phase 1/2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged 18 years or older, and Phase Ⅰb: Patients with histologically confirmed diagnosis of advanced soft tissue sarcomas (including malignant PEComa, accounting for at least 1/2) have failed standard treatment (disease progression or relapse or intolerance to chemotherapy, radiotherapy, targeted therapy, etc.) or lack effective treatment; Phase Ⅱ: Patients must have a histologically confirmed diagnosis of malignant PEComa that is either metastatic or locally advanced and for which surgery is not a recommended option.
  • [Malignant PEComas displaying 2 or more of the features of large size (> 5 cm), infiltrative growth, high nuclear grade, cellular necrosis, mitoses ≥1/50 high power field (HPF), or vascular invasion]
  • At least 1 measurable lesion as defined by RECIST 1.1.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
  • Life expectancy >3 months.
  • Patient must have the following biological parameters levels at screening (without blood transfusion, EPO, G-CSF and other medical support within14 days prior to screening tests):
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  • Blood tests: Absolute neutrophil count (ANC) ≥1.5 × 10^9/L; Platelet count ≥100 × 10^9/L; Hemoglobin ≥90 g/L; Renal function tests: serum creatinine ≤1.5 x upper limit of normal (ULN); Liver function tests: Total bilirubin ≤1.5 x ULN (Patients with liver metastases, bile duct obstruction, or confirmed Gilbert syndrome: ≤ 3×ULN); AST and ALT ≤2.5 x ULN (≤5 x ULN if attributable to liver metastases); Blood clotting function tests: INR or PT ≤ 1.5 × ULN; APTT≤ 1.5 × ULN;
  • Fasting serum triglycerides<300 mg/dL(3.42 mmol/L), fasting serum cholesterol < 350 mg/dL ( 9.07mmol/L; ).
  • Fasting blood glucose (FPG) < 7.8 mmol/L and HbA1c < 8%.
  • Women of child-bearing potential, or men whose partners are women of childbearing age must agree to use reliable contraceptive methods during the trial period and at least 6 months after the last administration; women of childbearing age must have a negative serum pregnancy test within 7 days prior to the first administration, should not be breast feeding.
  • Patients must give informed consent to the study prior to the trial and voluntarily sign informed consent form.

Who cannot join

  • Anti-tumor therapy such as chemotherapy, radiotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy within 4 weeks prior to the first dose of study drug, with the following special requirements:
  • Nitrosoureas (eg, carmustine, lomustine, etc.) or mitomycin C within 6 weeks prior to the first dose of study drug; Oral fluorouracils and small molecule targeted drugs within 2 weeks or 5 half-lives (whichever is longer) before the first dose of study drug; Traditional Chinese medicines with anti-tumor indications within 2 weeks prior to the first dose of study drug;
  • Received other unmarketed clinical investigational drug within 4 weeks prior to the first dose of study drug.
  • Major surgical procedures within 4 weeks prior to the first dose of study drug or not fully recovered from any previous invasive procedures.
  • Received systemic glucocorticoids (prednisone > 10 mg/day or equivalent doses) or other immunosuppressive therapy within 2 weeks prior to the first dose of the study drug [with the following exceptions: treatment with topical, ocular, intra-articular, intranasal, and inhaled corticosteroids; short-term use of glucocorticoids for prophylaxis (eg, prevention of contrast allergy)].
  • Infection that required systemic anti-infective therapy (oral or IV) within 2 weeks before enrollment.
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  • Inactivated or live attenuated vaccine or novel coronavirus vaccine within 30 days before the first dose.
  • Use of strong inhibitors or inducers of CYP3A4 within 2 weeks prior to the first dose of study drug, or requiring concomitant treatment during the study.
  • History of other malignancies within 5 years prior to the first dose of the study drug, except in the following cases: cured basal cell or squamous cell skin cancer, superficial bladder cancer, prostatic carcinoma in situ, carcinoma in situ of the cervix, breast carcinoma in situ, etc., or locally curable cancer that has been disease-free for 5 years;
  • Liver-directed therapy is required within 2 months of enrollment. Prior treatment with radiotherapy (including radio-labeled spheres and/or cyberknife, hepatic arterial embolization (with or without chemotherapy) or cyrotherapy/ablation) is allowed if these therapies does not affect the areas of measurable disease being used for this protocol.
  • History of serious cardiovascular disease, such as severe heart rhythm or conduction abnormalities (ventricular arrhythmias requiring clinical intervention, grade Ⅱ or Ш atrioventricular block, etc.). History of myocardial infarction, unstable angina, heart failure, New York College of Cardiology (NYHA) grade Ⅱ and above, and coronary artery bypass surgery within 6 months before the first dose of the study drug; Left ventricular ejection fraction (LVEF) < 50%, QTcF > 450 msec (male) or female QTcF > 470 msec (female), etc.
  • Unresolved toxicity from prior anti-tumor therapy greater than Grade 1 as per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.(except for alopecia and any other toxicities that have no safety risk judged by the investigator).
  • Known active uncontrolled or symptomatic central nervous system (CNS) metastases, or other evidence of uncontrollable central nervous system metastases or meningeal metastases that not eligible for inclusion determined by the investigator.
  • Hydrothorax, ascites or pericardial effusion with clinical symptoms or required symptomatic treatment.
  • Patients with angiomyolipoma(AML) or lymphangioleiomyomatosis (LAM).
  • History of serious lung disease, such as interstitial lung disease and/or pneumonitis, or pulmonary hypertension, or pre-existing severely impaired lung function.
  • Pre-existing thyroid abnormality is allowed provided thyroid function can be controlled with medication.
  • Known hypersensitivity or intolerance to any ingredient in the study drug.
  • History of autoimmune disease (except tuberous sclerosis), immunodeficiency, including positive HIV test, or other acquired or congenital immunodeficiency disease, or history of organ transplantation.
  • Active Hepatitis B or Hepatitis C, or active syphilis infection Active Hepatitis B: HBsAg-positive with HBV DNA titer ≥ 1 × 10^3 IU/mL; Patients are eligible for enrollment if they are HBsAg positive with peripheral blood HBV-DNA < 1 × 10^3 IU/mL if, in the opinion of the investigator, the patient's chronic hepatitis B is in a stable phase and does not increase the subject's risk.
  • Active Hepatitis C: HCV antibodies -positive with HCV RNA-positive; Active syphilis infection: Treponema pallidum antibodies (RPR or TRUST)-positive or presence of syphilis infection requiring systemic therapy.
  • Severe concomitant diseases that endanger patient safety, interfere the compliance of the study procedure (such as uncontrollable hypertension, active gastrointestinal bleeding, etc.) or other reasons that make the patient inappropriate for entry into this study.

Trial locations and contacts

1 site in 1 country.

Xiaohui Niu contact

+86-1381132522

niuxiaohui@263.net

China1 site, 1 recruiting

  • Beijing Jishuitan Hospital

    Beijing

    Xiaohui Niu, +861381132522, niuxiaohui@263.net

    Recruiting

Other trials in China

About this study

Official title: A Phase Ⅰb/Ⅱ Multi-center Study of Safety and Efficacy of Sirolimus for Injection (Albumin-bound) in Patients With Advanced Malignant Perivascular Epithelioid Cell Tumor (PEComa)

This is a phase Ⅰb/Ⅱ multi-center study of safety and efficacy of Sirolimus for Injection (Albumin-bound) in patients with advanced malignant perivascular epithelioid cell tumor (PEComa).

Read the detailed description

This is a non-randomized, multi-center, open-label, Phase Ⅰb/Ⅱ clinical trial. For phase Ⅰb, patients must have a histologically confirmed diagnosis of advanced soft tissue sarcomas (including malignant PEComa, accounting for at least 1/2) that have failed standard treatment (disease progression or relapse or intolerance, such as chemotherapy, radiotherapy, targeted therapy, etc.) or lack effective treatment. The recommended phase II dose (RP2D) will be determined in phase Ⅰb. For phase Ⅱ, patients must have a histologically confirmed diagnosis of malignant PEComa that is either metastatic or locally advanced and for which surgery is not a recommended option. Phase Ⅱ will use the recommended dose and dosing regimen from Phase Ⅰb.

Being tested
Sirolimus for Injection (Albumin Bound)
Medical subject headings
Perivascular Epithelioid Cell Neoplasms

What participants receive

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

  • Sirolimus for Injection (Albumin Bound)Drug

    Sirolimus for injection (Albumin-bound), intravenously, once a week, 21 days per cycle (two weeks-on and one week-off)

Study groups in NCT05625919
Study groupRoleWhat they receive
Sirolimus for Injection (Albumin-bound)ExperimentalSirolimus for injection (Albumin-bound) will be administered intravenously on day 1and day 8 every 21 days (a cycle).
Receives: Drug: Sirolimus for Injection (Albumin Bound)

What is being measured

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

  1. AE and SAE occurrence and frequency in phase Ⅰb

    Measured: Up to 2 years

  2. Dose-limiting toxicities (DLT)

    Measured: Cycle 1 (Up to 21 days)

  3. Maximum tolerated dose (MTD)

    Measured: Cycle 1 (Up to 21 days)

  4. Recommended phase 2 dose (RP2D)

    Measured: Cycle 1 (Up to 21 days)

  5. Overall response rate (ORR) in phase Ⅱ

    Measured: Up to 2 years

Secondary outcomes (10)

  1. Overall response rate (ORR) in phase Ⅰb

    Measured: Up to 2 years

  2. Disease Control Rate (DCR)

    Measured: Up to 2 years

  3. Duration of Response (DOR)

    Measured: Up to 2 years

  4. Progression-free Survival (PFS)

    Measured: Up to 2 years

  5. Overall survival (OS)

    Measured: Up to 2 years

  6. AE and SAE occurrence and frequency in phase Ⅱ

    Measured: Up to 2 years

  7. Area under the plasma concentration versus time curve (AUC)

    Measured: Up to 2 years

  8. Peak Plasma Concentration (Cmax)

    Measured: Up to 2 years

  9. Peak time (Tmax)

    Measured: Up to 2 years

  10. Terminal half-life (t½)

    Measured: Up to 2 years

Timeline

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

  1. First posted23 Nov 2022
  2. Study start8 Nov 2022
  3. Primary completionNov 2024 (estimated)
  4. Study completionNov 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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
54 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05625919
Sponsor's protocol ID
HB1901-004
Status last verified
Nov 2022
First submitted
14 Nov 2022
Last updated
28 Nov 2022
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 1/2 study testing Sirolimus for Injection (Albumin Bound) in people with Advanced Malignant Perivascular Epithelioid Cell Tumor (PEComa), run by CSPC ZhongQi Pharmaceutical Technology 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 11 inclusion and 22 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 28 Nov 2022. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 Xiaohui Niu (+86-1381132522, niuxiaohui@263.net), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AE and SAE occurrence and frequency in phase Ⅰb (time frame: Up to 2 years). The study lists 5 primary outcomes in all. 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 NCT05625919.

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 28 Nov 2022.

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