Malignant Solid TumorsPhase 1NCT05508620
A Study of Sirolimus for Injection (Albumin-bound) in Patients With Advanced Solid Tumors
A Phase 1 study testing Sirolimus for Injection (Albumin-bound) in people with Malignant Solid Tumors, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd..
Trial summary
This is an open-label, multi-center phase 1b study to evaluate the safety and efficacy of Sirolimus for injection (albumin-bound) in patients with malignant solid tumors with TSC1 or TSC2 genetic alterations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Solid Tumors
- 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
- 270 participants
- Where
- No sites listed yet
- Study dates
- Oct 2022to Dec 2024
- Phase
- Phase 1
- 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
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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
This is an open-label, multi-center phase 1b study to evaluate the safety and efficacy of Sirolimus for injection (albumin-bound) in patients with malignant solid tumors with TSC1 or TSC2 genetic alterations.
Read the 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.
- Conditions
- Malignant Solid Tumors
- Being tested
- Sirolimus for Injection (Albumin-bound)
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
Intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Sirolimus for Injection (Albumin-bound) | Experimental | Treatment with Sirolimus for Injection (Albumin-bound) will continue until disease progression, unacceptable toxicity, or other discontinuation criteria, whichever occurs first. Receives: Drug: Sirolimus for Injection (Albumin-bound) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicities (DLT)
Measured: At the end of Cycle 1 (each cycle is 21 days)
Recommended phase 2 dose (RP2D)
Measured: Up to 2 years
Overall response rate (ORR)
Measured: Up to 2 years
Secondary outcomes (7)
Disease Control Rate (DCR)
Measured: Up to 2 years
Duration of Response (DOR)
Measured: Up to 2 years
Progression-free Survival (PFS)
Measured: Up to 2 years
Overall survival (OS)
Measured: Up to 2 years
Maximum Plasma Concentration (Cmax)
Measured: Up to18 weeks
Time to reach maximum plasma concentration (Tmax)
Measured: Up to18 weeks
Area Under the Curve (AUC)
Measured: Up to18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2022
- Study startOct 2022 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Solid TumorsStudies of the same condition, open and under way.
- More trials run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05508620
- Sponsor's protocol ID
- HB1901-003
- Status last verified
- Aug 2022
- First submitted
- 15 Aug 2022
- Last updated
- 23 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05508620
- Acronym / sponsor ID
- HB1901-003
- Conditions
- Malignant Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2022 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 19 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, multi-center phase 1b study to evaluate the safety and efficacy of Sirolimus for injection (albumin-bound) in patients with malignant solid tumors with TSC1 or TSC2 genetic alterations.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sirolimus for Injection (Albumin-bound) | Experimental | Drug: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sirolimus for Injection (Albumin-bound)Intravenous infusion | Drug | Sirolimus for Injection (Albumin-bound) |
Primary outcome
Dose-limiting toxicities (DLT)
Time frame: At the end of Cycle 1 (each cycle is 21 days)
Recommended phase 2 dose (RP2D)
Time frame: Up to 2 years
Overall response rate (ORR)
Time frame: Up to 2 years
7 secondary outcomes
Disease Control Rate (DCR)
Time frame: Up to 2 years
Duration of Response (DOR)
Time frame: Up to 2 years
Progression-free Survival (PFS)
Time frame: Up to 2 years
Overall survival (OS)
Time frame: Up to 2 years
Maximum Plasma Concentration (Cmax)
Time frame: Up to18 weeks
Time to reach maximum plasma concentration (Tmax)
Time frame: Up to18 weeks
Area Under the Curve (AUC)
Time frame: Up to18 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sirolimus for Injection (Albumin-bound) in people with Malignant Solid Tumors, 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 10 inclusion and 17 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 23 Aug 2022. 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 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.
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 Zhehao Piao (+86-024-81916392, pzpy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicities (DLT) (time frame: At the end of Cycle 1 (each cycle is 21 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Aug 2022.