A Study of Sirolimus (Albumin-Bound) in Combination With Different ADCs Treatment of Advanced Solid Tumors
NCT07241936
Phase
Phase 1/Phase 2
Recruitment status
Recruiting
Participants
Lead sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Start date
2025-11-13
Number of sites
- 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 (DP303c/SYS6043/SYS6002/SYS6010) in this patient population, and to confirm the recommended phase 2 dose (RP2D).
- Short title
- A Study of Sirolimus (Albumin-Bound) in Combination With Different ADCs Treatment of Advanced Solid Tumors
- 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
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Recruiting
- Phase
- Phase 1/Phase 2
- Study type
- Interventional
- Completion date
- 2028-10-30
- First posted
- 2025-11-21
- Registry last updated
- 2025-11-28
- Primary completion date
- 2027-10-30
- Start date
- 2025-11-13
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07241936
- ClinicalTrials.gov ID
- NCT07241936
- Registry record
- Open registry record
- Allocation
- Not randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- No masking
Sources for study design
The occurrence and frequency of adverse events (AE) and serious adverse events (SAE)
Timeframe: Up to approximately 36 weeks after the first participant is enrolled
dose - limiting toxicities (DLT)
Timeframe: Up to approximately 36 weeks after the first participant is enrolled
The recommended phase 2 dose
Timeframe: Up to approximately 36 weeks after the first participant is enrolled
Sources for outcomes
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Healthy volunteers
- No
- 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.
- 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).
- 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.
- 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.
Sources for eligibility
- Fudan University Shanghai Cancer CenterShanghai, ChinaRecruiting
Sources for sites