Advanced Solid TumorsPhase 1/2NCT07241936
A Study of Sirolimus (Albumin-Bound) in Combination With Different ADCs Treatment of Advanced Solid Tumors
A Phase 1/2 study testing sirolimus (albumin-bound), DP303c and SYS6043 in people with Advanced Solid Tumors, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.
Trial summary
This study adopts a multi-center, open-label, non-randomized trial design. It plans to enroll patients with Advanced solid tumor. Dose-escalation and PK-expansion studies will be carried out to evaluate the safety, tolerability, and preliminary efficacy of sirolimus (albumin-bound) in combination with Different ADCs… 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 (albumin-bound), DP303c and SYS6043
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 444 participants
- Where
- 1 siteChina
- Study dates
- 13 Nov 2025to 30 Oct 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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
- 1. Subjects aged 18 to 75 years (inclusive).
- 2. Patients with advanced solid tumors that are unresectable or metastatic and confirmed by histology or cytology.
- 3. At least one measurable lesion, as defined by RECIST 1.1 criteria.
- 4. ECOG performance status of 0 or 1.
- 5. Expected survival ≥ 3 months.
- 6. Adequate function of major organs and bone marrow.
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- 7. Willing to provide samples of previously removed tumors or undergo fresh tumor biopsy.
- 8. Women or man of childbearing potential must use highly effective contraception.
- 9. Able to understand and voluntarily sign the written informed consent form (ICF).
Who cannot join
- 1. Previous use of antibody-conjugated drugs with similar loading agents for treatment.
- 2. Previous anti-tumor treatment drugs were not adequately removed.
- 3. Active leptomeningeal disease or uncontrolled CNS metastasis.
- 4. Having a history of severe or uncontrolled cardiovascular or cerebrovascular diseases.
- 5. Previous interstitial lung disease requiring glucocorticoid treatment, Or currently suffering from interstitial lung disease/non-infectious pneumonia, or the imaging examination during the screening period cannot rule out interstitial pneumonia/lung disease.
- 6. Patients who developed severe and moderately severe lung diseases that significantly affected lung function within 6 months of the first medication administration; patients requiring supplementary oxygen therapy.
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- 7. Individuals who currently have eye diseases such as corneal disorders, retinal disorders, or active ocular infections that require intervention, or who have a history of serious corneal-related eye diseases in the past; or who are unwilling to stop wearing corneal contact lenses during the study; or who have other existing eye diseases that affect the assessment of ocular toxicity after the administration of the investigational drug.
- 8. Currently suffering from skin diseases that require oral or intravenous medication treatment.
- 9. Had a history of ulcerative colitis or Crohn's disease.
- 10. Within 14 days prior to the first administration of the medication, there is a need for systemic antibacterial, antifungal or antiviral treatment for severe chronic or active infections, and there is no cure for active tuberculosis.
- 11. Known to be allergic to any component of the test drug, or allergic to the humanized monoclonal antibody product.
- 12. Participants with poor compliance.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai
Jian Zhang, syner2000@163.com
About this study
Official title: A Phase Ib/II Clinical Trial on the Safety and Efficacy of Sirolimus (Albumin-bound) Combined With Different ADCs in Patients With Advanced Solid Tumors
This study adopts a multi-center, open-label, non-randomized trial design. It plans to enroll patients with Advanced solid tumor. Dose-escalation and PK-expansion studies will be carried out to evaluate the safety, tolerability, and preliminary efficacy of sirolimus (albumin-bound) in combination with Different ADCs (DP303c/SYS6043/SYS6002/SYS6010) in this patient population, and to confirm the recommended phase 2 dose (RP2D).
- Conditions
- Advanced Solid Tumors
- Being tested
- sirolimus (albumin-bound), DP303c, SYS6043, SYS6002, SYS6010
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sirolimus (albumin-bound)Drug
intravenous infusion
DP303cDrug
intravenous infusion
SYS6043Drug
intravenous infusion
SYS6002Drug
intravenous infusion
SYS6010Drug
intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| sirolimus (albumin-bound)+ DP303c | Experimental | Not described Receives: Drug: sirolimus (albumin-bound); Drug: DP303c |
| sirolimus (albumin-bound)+ SYS6043 | Experimental | Not described Receives: Drug: sirolimus (albumin-bound); Drug: SYS6043 |
| sirolimus (albumin-bound)+ SYS6002 | Experimental | Not described Receives: Drug: sirolimus (albumin-bound); Drug: SYS6002 |
| sirolimus (albumin-bound)+ SYS6010 | Experimental | Not described Receives: Drug: sirolimus (albumin-bound); Drug: SYS6010 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The occurrence and frequency of adverse events (AE) and serious adverse events (SAE)
Measured: Up to approximately 36 weeks after the first participant is enrolled
dose - limiting toxicities (DLT)
Measured: Up to approximately 36 weeks after the first participant is enrolled
The recommended phase 2 dose
Measured: Up to approximately 36 weeks after the first participant is enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start13 Nov 2025
- Primary completion30 Oct 2027 (estimated)
- Study completion30 Oct 2028 (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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Dose escalation and expansion
- Masking
- None (open label)
- Enrolment
- 444 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
- NCT07241936
- Sponsor's protocol ID
- HB1901-012
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/II Clinical Trial on the Safety and Efficacy of Sirolimus (Albumin-bound) Combined With Different ADCs in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07241936
- Acronym / sponsor ID
- HB1901-012
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 444 participants (estimated)
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Nov 2025 (actual)
- Primary completion
- 30 Oct 2027 (estimated)
- Study completion
- 30 Oct 2028 (estimated)
- First posted
- 21 Nov 2025 (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 study adopts a multi-center, open-label, non-randomized trial design. It plans to enroll patients with Advanced solid tumor. Dose-escalation and PK-expansion studies will be carried out to evaluate the safety, tolerability, and preliminary efficacy of sirolimus (albumin-bound) in combination with Different ADCs (DP303c/SYS6043/SYS6002/SYS6010) in this patient population, and to confirm the recommended phase 2 dose (RP2D).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Dose escalation and expansion
| Arm | Type | Receives |
|---|---|---|
| sirolimus (albumin-bound)+ DP303c | Experimental | Drug: sirolimus (albumin-bound), Drug: DP303c |
| sirolimus (albumin-bound)+ SYS6043 | Experimental | Drug: sirolimus (albumin-bound), Drug: SYS6043 |
| sirolimus (albumin-bound)+ SYS6002 | Experimental | Drug: sirolimus (albumin-bound), Drug: SYS6002 |
| sirolimus (albumin-bound)+ SYS6010 | Experimental | Drug: sirolimus (albumin-bound), Drug: SYS6010 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 1. Subjects aged 18 to 75 years (inclusive).
- 2. Patients with advanced solid tumors that are unresectable or metastatic and confirmed by histology or cytology.
- 3. At least one measurable lesion, as defined by RECIST 1.1 criteria.
- 4. ECOG performance status of 0 or 1.
- 5. Expected survival ≥ 3 months.
Key exclusion criteria (12 listed)
- 1. Previous use of antibody-conjugated drugs with similar loading agents for treatment.
- 2. Previous anti-tumor treatment drugs were not adequately removed.
- 3. Active leptomeningeal disease or uncontrolled CNS metastasis.
- 4. Having a history of severe or uncontrolled cardiovascular or cerebrovascular diseases.
- 5. Previous interstitial lung disease requiring glucocorticoid treatment, Or currently suffering from interstitial lung disease/non-infectious pneumonia, or the imaging examination during the screening period cannot rule out interstitial pneumonia/lung disease.
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 (albumin-bound)intravenous infusion | Drug | sirolimus (albumin-bound)+ DP303c, sirolimus (albumin-bound)+ SYS6002, sirolimus (albumin-bound)+ SYS6010, sirolimus (albumin-bound)+ SYS6043 |
| DP303cintravenous infusion | Drug | sirolimus (albumin-bound)+ DP303c |
| SYS6043intravenous infusion | Drug | sirolimus (albumin-bound)+ SYS6043 |
| SYS6002intravenous infusion | Drug | sirolimus (albumin-bound)+ SYS6002 |
| SYS6010intravenous infusion | Drug | sirolimus (albumin-bound)+ SYS6010 |
Primary outcome
The occurrence and frequency of adverse events (AE) and serious adverse events (SAE)
Time frame: Up to approximately 36 weeks after the first participant is enrolled
dose - limiting toxicities (DLT)
Time frame: Up to approximately 36 weeks after the first participant is enrolled
The recommended phase 2 dose
Time frame: Up to approximately 36 weeks after the first participant is enrolled
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing sirolimus (albumin-bound), DP303c and SYS6043 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 9 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 28 Nov 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Information Group officer (86-0311-69085587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The occurrence and frequency of adverse events (AE) and serious adverse events (SAE) (time frame: Up to approximately 36 weeks after the first participant is enrolled). 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 28 Nov 2025.