A Study of Sirolimus (Albumin-Bound) in Combination With Different ADCs Treatment of Advanced Solid Tumors

NCT07241936 | Recruiting Phase 1 DMC

• 1 other identifier: HB1901-012
• Study Type: interventional
• Target: 444
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (3)

• The occurrence and frequency of adverse events (AE) and serious adverse events (SAE)

  Up to approximately 36 weeks after the first participant is enrolled

• dose - limiting toxicities (DLT)

  Up to approximately 36 weeks after the first participant is enrolled

• The recommended phase 2 dose

  Up to approximately 36 weeks after the first participant is enrolled

Study Arms (4)

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

Interventions

sirolimus (albumin-bound) DRUG

intravenous infusion

sirolimus (albumin-bound)+ DP303c; sirolimus (albumin-bound)+ SYS6002; sirolimus (albumin-bound)+ SYS6010; sirolimus (albumin-bound)+ SYS6043

DP303c DRUG

intravenous infusion

sirolimus (albumin-bound)+ DP303c

SYS6043 DRUG

intravenous infusion

sirolimus (albumin-bound)+ SYS6043

SYS6002 DRUG

intravenous infusion

sirolimus (albumin-bound)+ SYS6002

SYS6010 DRUG

intravenous infusion

sirolimus (albumin-bound)+ SYS6010

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Subjects aged 18 to 75 years (inclusive).
• \. Patients with advanced solid tumors that are unresectable or metastatic and confirmed by histology or cytology.
• \. At least one measurable lesion, as defined by RECIST 1.1 criteria.
• \. ECOG performance status of 0 or 1.
• \. Expected survival ≥ 3 months.
• \. Adequate function of major organs and bone marrow.
• \. Willing to provide samples of previously removed tumors or undergo fresh tumor biopsy.
• \. Women or man of childbearing potential must use highly effective contraception.
• \. Able to understand and voluntarily sign the written informed consent form (ICF).

You may not qualify if:

• \. Previous use of antibody-conjugated drugs with similar loading agents for treatment.
• \. Previous anti-tumor treatment drugs were not adequately removed.
• \. Active leptomeningeal disease or uncontrolled CNS metastasis.
• \. Having a history of severe or uncontrolled cardiovascular or cerebrovascular diseases.
• \. 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.
• \. 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.
• \. 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.
• \. Currently suffering from skin diseases that require oral or intravenous medication treatment.
• \. Had a history of ulcerative colitis or Crohn's disease.
• \. 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.
• \. Known to be allergic to any component of the test drug, or allergic to the humanized monoclonal antibody product.
• \. Participants with poor compliance.

Sponsors & Collaborators

• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, China

RECRUITING

MeSH Terms

Interventions

Sirolimus

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Central Study Contacts

Clinical Trials Information Group officer

CONTACT

86-0311-69085587; ctr-contact@cspc.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Dose escalation and expansion

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 21, 2025
• Study Start: November 13, 2025
• Primary Completion (Estimated): October 30, 2027
• Study Completion (Estimated): October 30, 2028
• Last Updated: November 28, 2025

Record last verified: 2025-11

Locations

CN (1)