Advanced Solid TumorsPhase 1NCT05125523
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 Advanced Solid Tumors, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to estimate the safety, tolerability, pharmacokinetics (PK), and antitumor activity of Sirolimus for Injection (Albumin Bound) in patients with solid malignancies. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced 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
- 264 participants
- Where
- 1 siteChina
- Study dates
- 28 Dec 2021to Nov 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years (inclusive), no gender limitation.
- Patients must have a histologically or cytologically confirmed advanced or metastatic tumor for which no effective standard therapy is available, or have failed or been intolerant to standard therapies.
- At least one measurable lesion per RECIST version 1.1.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 2.
- Life expectancy of ≥3 months.
- Suitable organs and hematopoietic function should be available. Laboratory tests during screening should meet the appropriate criteria.
- Signed informed consent form.
Who cannot join
- Prior anticancer treatment or participation in another clinical study within 4 weeks (or 5 half-lives of the treated drug, whichever is longer) prior to the first dose of study drugs.
- Patients who have undergone major surgery within 4 weeks prior to starting study treatment, or who have not fully recovered from previous surgery.
- Unresolved toxicities from prior therapy greater than Grade 1 as per Common Terminology Criteria for Adverse Events (CTCAE) (except alopecia or any other toxicity without safety risks as judged by the investigator).
- History of serious cardiovascular disease.
- Central nervous system metastasis or meningeal metastasis with clinical symptoms, or other evidence that the patient's central nervous system metastasis or meningeal metastasis has not been controlled, and the investigator judges it to be unsuitable for inclusion.
- Known prior hypersensitivity to study drugs or any component in their formulations.
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- Prior treatment with any mTOR inhibitor.
- Has received a live or live-attenuated virus vaccine within 30 days prior to consent.
- Uncontrollable active infection (CTCAE v5.0 ≥grade 2).
- Use of strong inhibitors and inducers of CYP3A4 within 2 weeks prior to receiving the first dose of study drug and still need to continue using this class of drug.
- History of autoimmune diseases, immunodeficiency, including HIV positive, or other acquired, congenital immunodeficiency, or organ transplant history.
- HBsAg-positive with HBV viral load (VL) ≥1000 IU/mL; Hepatitis C Virus (HCV)-positive; Anti-treponema pallidum positive.
- Women of child-bearing potential, or men whose partners are women of childbearing age, have not agree to use highly effective methods of contraception during dosing and for 6 months after study drug discontinuation; female patients has a positive serum pregnancy test within 7 days prior to receiving the first dose of study medication; lactating female.
- Has history of other serious diseases judged by the investigator, which will threaten the safety of patients or interfere the study compliance, or other reasons are not suitable for participating in the study.
Trial locations and contacts
1 site in 1 country.
Yue Huang contact
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060
Jihui Hao, haojihui@tjmuch.com
Yehui Shi, shiyehui@tjmuch.com
About this study
Official title: A Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics (PK) and Antitumor Activity of Sirolimus for Injection (Albumin Bound) in Patients With Advanced Solid Tumors
The purpose of this study is to estimate the safety, tolerability, pharmacokinetics (PK), and antitumor activity of Sirolimus for Injection (Albumin Bound) in patients with solid malignancies.
Read the detailed description
This study will be conducted in two stages.
Stage 1: To evaluate the safety and tolerability of Sirolimus for Injection (Albumin Bound) in patients with advanced tumors, determine the MTD and RP2D. The dose escalation scheme using the accelerated titration design for dose 1 and the rolling-six design for the remaining doses.
Stage 2: To preliminarily assess the antitumor activity of Sirolimus for Injection (Albumin Bound). Patients will be assigned to different cohorts based on their tumor type.
- Conditions
- Advanced Solid Tumors
- Being tested
- Sirolimus for Injection (Albumin Bound)
- Keywords
- 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
Sirolimus for Injection (Albumin Bound), intravenously, once a week, 28 days per cycle (three weeks-on and one week-off)
| Study group | Role | What they receive |
|---|---|---|
| Sirolimus for Injection (Albumin Bound) | Experimental | Stage 1：Multiple doses of Sirolimus for Injection (Albumin Bound) will be administered intravenously.
Stage 2：RP2D of Sirolimus for Injection (Albumin Bound) as determined during stage 1 will be administered intravenously. Receives: Drug: Sirolimus for Injection (Albumin Bound) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events
Measured: Up to 3 years
Dose-Limiting Toxicities (Stage 1)
Measured: Cycle 1 (Up to 28 days)
Maximum tolerated dose (Stage 1)
Measured: Up to 1.5 years
Recommended phase 2 dose (Stage 1)
Measured: Up to 1.5 years
Overall response rate (Stage 2)
Measured: Up to 3 years
Secondary outcomes (14)
Area under the plasma concentration versus time curve (AUC)
Measured: Day 1 of cycle 1 to Day 1 of cycle 4 (85 days)
Peak concentration (Cmax)
Measured: Day 1 of cycle 1 to Day 1 of cycle 4 (85 days)
Peak time (Tmax)
Measured: Day 1 of cycle 1 to Day 1 of cycle 4 (85 days)
Distribution volume (Vz)
Measured: Day 1 of cycle 1 to Day 1 of cycle 4 (85 days)
Elimination half-life (t1/2)
Measured: Day 1 of cycle 1 to Day 1 of cycle 4 (85 days)
Clearance (CL)
Measured: Day 1 of cycle 1 to Day 1 of cycle 4 (85 days)
Disease Control Rate
Measured: Up to 3 years
Duration of Response
Measured: Up to 3 years
Progression-free Survival
Measured: Up to 3 years
4ebp-1 phosphorylation level in blood samples
Measured: Up to 168 hours post dose
S6K phosphorylation level in blood samples
Measured: Up to 168 hours post dose
TSC1/2 status in tumor samples
Measured: Day 1 of cycle 1
PTEN status in tumor samples
Measured: Day 1 of cycle 1
PIK3CA status in tumor samples
Measured: Day 1 of cycle 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2021
- Study start28 Dec 2021
- Primary completionJun 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced 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
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jihui Hao, Principal investigator, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05125523
- Sponsor's protocol ID
- HB1901-CSP-001
- Status last verified
- Nov 2021
- First submitted
- 25 Oct 2021
- Last updated
- 25 Jan 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 25 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics (PK) and Antitumor Activity of Sirolimus for Injection (Albumin Bound) in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05125523
- Acronym / sponsor ID
- HB1901-CSP-001
- Conditions
- Advanced Solid Tumors
- Keywords
- Sirolimus for Injection (Albumin Bound)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Dec 2021 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 18 Nov 2021 (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.
The purpose of this study is to estimate the safety, tolerability, pharmacokinetics (PK), and antitumor activity of Sirolimus for Injection (Albumin Bound) in patients with solid malignancies.
Detailed description
This study will be conducted in two stages.
Stage 1: To evaluate the safety and tolerability of Sirolimus for Injection (Albumin Bound) in patients with advanced tumors, determine the MTD and RP2D. The dose escalation scheme using the accelerated titration design for dose 1 and the rolling-six design for the remaining doses.
Stage 2: To preliminarily assess the antitumor activity of Sirolimus for Injection (Albumin Bound). Patients will be assigned to different cohorts based on their tumor type.
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)Stage 1：Multiple doses of Sirolimus for Injection (Albumin Bound) will be administered intravenously. Stage 2：RP2D of Sirolimus for Injection (Albumin Bound) as determined during stage 1 will be administered intravenously. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18-75 years (inclusive), no gender limitation.
- Patients must have a histologically or cytologically confirmed advanced or metastatic tumor for which no effective standard therapy is available, or have failed or been intolerant to standard therapies.
- At least one measurable lesion per RECIST version 1.1.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 2.
- Life expectancy of ≥3 months.
Key exclusion criteria (14 listed)
- Prior anticancer treatment or participation in another clinical study within 4 weeks (or 5 half-lives of the treated drug, whichever is longer) prior to the first dose of study drugs.
- Patients who have undergone major surgery within 4 weeks prior to starting study treatment, or who have not fully recovered from previous surgery.
- Unresolved toxicities from prior therapy greater than Grade 1 as per Common Terminology Criteria for Adverse Events (CTCAE) (except alopecia or any other toxicity without safety risks as judged by the investigator).
- History of serious cardiovascular disease.
- Central nervous system metastasis or meningeal metastasis with clinical symptoms, or other evidence that the patient's central nervous system metastasis or meningeal metastasis has not been controlled, and the investigator judges it to be unsuitable for inclusion.
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)Sirolimus for Injection (Albumin Bound), intravenously, once a week, 28 days per cycle (three weeks-on and one week-off) | Drug | Sirolimus for Injection (Albumin Bound) |
Primary outcome
Number of participants with adverse events
Time frame: Up to 3 years
Dose-Limiting Toxicities (Stage 1)
Time frame: Cycle 1 (Up to 28 days)
Maximum tolerated dose (Stage 1)
Time frame: Up to 1.5 years
Recommended phase 2 dose (Stage 1)
Time frame: Up to 1.5 years
Overall response rate (Stage 2)
Time frame: Up to 3 years
14 secondary outcomes
Area under the plasma concentration versus time curve (AUC)
Time frame: Day 1 of cycle 1 to Day 1 of cycle 4 (85 days)
Peak concentration (Cmax)
Time frame: Day 1 of cycle 1 to Day 1 of cycle 4 (85 days)
Peak time (Tmax)
Time frame: Day 1 of cycle 1 to Day 1 of cycle 4 (85 days)
Distribution volume (Vz)
Time frame: Day 1 of cycle 1 to Day 1 of cycle 4 (85 days)
Elimination half-life (t1/2)
Time frame: Day 1 of cycle 1 to Day 1 of cycle 4 (85 days)
Clearance (CL)
Time frame: Day 1 of cycle 1 to Day 1 of cycle 4 (85 days)
Disease Control Rate
Time frame: Up to 3 years
Duration of Response
Time frame: Up to 3 years
Progression-free Survival
Time frame: Up to 3 years
4ebp-1 phosphorylation level in blood samples
Time frame: Up to 168 hours post dose
S6K phosphorylation level in blood samples
Time frame: Up to 168 hours post dose
TSC1/2 status in tumor samples
Time frame: Day 1 of cycle 1
PTEN status in tumor samples
Time frame: Day 1 of cycle 1
PIK3CA status in tumor samples
Time frame: Day 1 of cycle 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 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.
Yue Huang contact
Jihui Hao principal investigator
Tianjin Medical University Cancer Institute and Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sirolimus for Injection (Albumin Bound) in people with Advanced Solid Tumors, 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 7 inclusion and 14 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 25 Jan 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 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 Xuekun Yao (0311-67808678, yaoxuekun@mail.ecspc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events (time frame: Up to 3 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?
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 25 Jan 2022.