- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05508620
A Study of Sirolimus for Injection (Albumin-bound) in Patients With Advanced Solid Tumors
A Phase Ib Study to Evaluate the Safety and Efficacy of Sirolimus for Injection (Albumin-bound) in Patients With Malignant Solid Tumors With TSC1/2 Genetic Alterations
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study will be conducted in two stages.
Stage 1: To evaluate the safety, tolerability and pharmacokinetics of Sirolimus for injection (albumin-bound), and determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D). The Rolling-six design will be used for dose escalation.
Stage 2: To assess the antitumor activities of Sirolimus for injection (albumin-bound) in patients with malignant solid tumors harboring genetic alterations in TSC1 or TSC2.
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Zhehao Piao
- Phone Number: +86-024-81916392
- Email: pzpy@163.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients must have histologically or cytologically confirmed diagnosis of malignant solid tumors, with TSC1 or TSC2 genetic alterations, and have no standard treatment or have failed standard treatments.
- Patients must have archival tumor tissues or agreed to have a tumor biopsy (if not, the sponsor's consent is required for enrollment).
- At least 1 measurable lesion as defined by RECIST 1.1.
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
- Life expectancy of ≥3 months.
- Adequate marrow and organ function.
- Fasting serum triglyceride must be <300 mg/dL or <3.42 mmol/L; fasting serum cholesterol must be<350 mg/dL or <9.07 mmol/L.
- Fasting blood glucose must be<6.1 mmol/L and HbA1c< 6.5% in dose escalation, in other stage must be < 7.8 mmol/L and be< 8% respectively.
- 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 should understand and willingness to sign a written informed consent form prior to study entry.
Exclusion Criteria:
- Prior treatment with an mTOR inhibitor.
- Anti-tumor treatment within 4 weeks prior to first dose of study treatment.
- Participation in another therapeutic clinical trial with 4 weeks before study treatment.
- Major surgery within 4 weeks prior to study treatment, or have not fully recovered from any previous procedure.
- Unresolved toxicity from prior anti-tumor therapy greater than Grade 1 as per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
- Patients with primary brain tumors or PEComa.
- Active uncontrolled or symptomatic central nervous system metastasis (CNS) or meningeal metastasis.
- History of serious cardiovascular disease.
- History of serious lung disease, such as interstitial lung disease and/or pneumonitis, or pulmonary hypertension, or pre-existing severely impaired lung function.
- Hydrothorax, ascites or pleural effusion with clinical symptoms or required treatment.
- Patients with hepatocellular carcinoma (HCC): Child-Pugh class B or C; or HCC with ≥50% liver occupation; or has a history or current evidence of hepatic encephalopathy; portal vein invasion at the main portal branch (Vp4).
- Live vaccine (including live attenuated vaccine) within 30 days before signing the informed consent.
- Infection that required systemic anti-infective therapy within 2 weeks before enrollment.
- History of autoimmune disease or immunodeficiency disease.
- Active Hepatitis B or Hepatitis C.
- Use of strong inhibitors or inducers of CYP3A4 within 2 weeks prior to start of treatment initiation, or requiring concomitant treatment during the study.
- Other server disease that may increase the risk of patients, or interfere the compliance of study procedures, or other reasons which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sirolimus for Injection (Albumin-bound)
Treatment with Sirolimus for Injection (Albumin-bound) will continue until disease progression, unacceptable toxicity, or other discontinuation criteria, whichever occurs first.
|
Intravenous infusion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Dose-limiting toxicities (DLT)
Time Frame: At the end of Cycle 1 (each cycle is 21 days)
|
At the end of Cycle 1 (each cycle is 21 days)
|
Recommended phase 2 dose (RP2D)
Time Frame: Up to 2 years
|
Up to 2 years
|
Overall response rate (ORR)
Time Frame: Up to 2 years
|
Up to 2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Progression-free Survival (PFS)
Time Frame: Up to 2 years
|
Up to 2 years
|
Overall survival (OS)
Time Frame: Up to 2 years
|
Up to 2 years
|
Disease Control Rate (DCR)
Time Frame: Up to 2 years
|
Up to 2 years
|
Duration of Response (DOR)
Time Frame: Up to 2 years
|
Up to 2 years
|
Maximum Plasma Concentration (Cmax)
Time Frame: Up to18 weeks
|
Up to18 weeks
|
Time to reach maximum plasma concentration (Tmax)
Time Frame: Up to18 weeks
|
Up to18 weeks
|
Area Under the Curve (AUC)
Time Frame: Up to18 weeks
|
Up to18 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HB1901-003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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