A First-in-Human Study of YL217 in Patients With Advanced Solid Tumors

NCT06859762
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Phase
Phase 1
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Recruitment status
Recruiting
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Participants
630
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Lead sponsor
MediLink Therapeutics (Suzhou) Co., Ltd.
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Start date
2025-07-02
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Number of sites
21
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Summary
A Phase 1 First-in-Human study of YL217 in Patients with Advanced Solid Tumors
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Short title
A First-in-Human Study of YL217 in Patients With Advanced Solid Tumors
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Official title
A Phase 1, Multicenter, Open-Label, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of YL217 in Patients With Advanced Solid Tumors
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2030-07-01
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First posted
2025-03-05
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Registry last updated
2026-09-18
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Primary completion date
2028-07-01
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Start date
2025-07-02
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Participants
630
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Participant count basis
Estimated
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Planned participants
630
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Protocol amendments
3
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Number of sites
21
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
MediLink Therapeutics (Suzhou) Co., Ltd.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06859762
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ClinicalTrials.gov ID
NCT06859762
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Registry record
Open registry record
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Allocation
Not randomised
Model
Sequential
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Nature and frequency of dose-limiting toxicity(DLT)

    Timeframe: Up to approximately 3 years

    The purpose of DLT is to find maximum tolerated dose (MTD).

  2. Nature and frequency of adverse events (AEs) with severity

    Timeframe: Up to approximately 3 years

    Nature and frequency of AEs with severity is aim to evaluate the safety of YL217.

  3. objective response rate (ORR)

    Timeframe: Up to approximately 3 years

    ORR: defined as the proportion of patients who achieved a best overall response of complete response (CR) or partial response (PR).

  1. Eastern Cooperative Oncology Group performance status (ECOG PS)

    Timeframe: Up to approximately 3 years

    Deterioration of Eastern Cooperative Oncology Group performance status (ECOG PS)

  2. To evaluate safety endpoint of peripheral oxygen saturation (SpO2)

    Timeframe: Up to approximately 3 years

  3. Characterize Pharmacokinetics(PK) parameter AUC

    Timeframe: Up to approximately 3 years

    The area under curve: AUC is the total amount of YL217 in bloodstream after drug administration.

  4. Characterize Pharmacokinetics(PK) parameter Cmax

    Timeframe: Up to approximately 3 years

    Maximum concentration：The highest measured concentration of YL217 in the bloodstream.

  5. Characterize Pharmacokinetics(PK) parameter Ctrough

    Timeframe: Up to approximately 3 years

    Trough concentration

  6. Characterize Pharmacokinetics(PK) parameter Tmax

    Timeframe: Up to approximately 3 years

    Time to maximum observed concentration

  7. Characterize Pharmacokinetics(PK) parameter CL

    Timeframe: Up to approximately 3 years

    Clearance： defined as the amount of drug removed from the bloodstream by the body per unit of time.

  8. Characterize Pharmacokinetics(PK) parameter Vd

    Timeframe: Up to approximately 3 years

    volume of distribution

  9. Characterize Pharmacokinetics(PK) parameter t1/2

    Timeframe: Up to approximately 3 years

    Half-life time：defined as the time it takes for the concentration of the drug in plasma or serum to be reduced by 50%.

  10. Immunogenicity endpoint: Incidence of anti-YL217 antibody (ADAs).

    Timeframe: Up to approximately 3 years

    The presence of ADAs in patients treated with YL217 will be assessed to evaluate immunogenicity.

  11. Disease control rate (DCR)

    Timeframe: Up to approximately 3 years

    DCR: defined as the proportion of patients who achieved a best overall response of complete response (CR), partial response (PR) or stable disease (SD).

  12. Duration of response (DoR)

    Timeframe: Up to approximately 3 years

    DoR: defined as the time interval from the date of the first documentation of objective response (CR or PR) to the date of the first documentation of progressive disease (PD).

  13. Time to response (TTR)

    Timeframe: Up to approximately 3 years

    TTR: defined as the time interval from the date of the first dose of study drug to the date of the first documentation of objective response (CR or PR).

  14. Depth of response (DpR)

    Timeframe: Up to approximately 3 years

    DpR: defined as the proportion of target lesion shrinkage from baseline to maximum tumor size.

  15. Progression-free survival (PFS)

    Timeframe: Up to approximately 3 years

    PFS: defined as the time interval from the date of the first dose of study drug to the date of first documentation of PD or death due to any cause, whichever occurs first.

  16. Overall survival (OS)

    Timeframe: Up to approximately 3 years

    OS: defined as the time interval from the date of the first dose of study drug to the date of death due to any cause.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • Informed of the study before the start of the study and voluntarily sign their name and date in the ICF
  • Able and willing to comply with protocol visits and procedures
  • Age≥ 18 years
  • ECOG PS of 0 or 1
  • Pathologically confirmed diagnosis of an advanced solid tumor. For CRC cohorts: : Histologically or cytologically documented locally advanced unresectable or metastatic colorectal carcinoma that is not eligible for curative surgery and/or definitive chemoradiotherapy
  • Adequate organ and bone marrow function.
  • Have at least 1 extracranial measurable tumor lesion.
  • Adequate archival formalin-fixed paraffin embedded （FFPE） tissue from prior biopsy.

  • Prior treatment with an agent targeting CDH17
  • Prior discontinuation of a topoisomerase I inhibitor due to treatment-related toxicities.
  • Have received an ADC consisting of a topoisomerase I inhibitor.
  • Concurrent enrollment in another clinical study, unless it is an observational clinical study.
  • Inadequate washout period for prior anticancer treatment before the first dose of study drug
  • Undergone major surgery within 4 weeks before the first dose of study drug or expect major surgery during the study, minor procedures (e.g., core needle biopsy, superficial biopsy) within 7 days before the first dose of study drug.
  • Received long term systemic steroids or other immunosuppressive therapy within 2 weeks before the first dose of study drug.
  • Received any live vaccine within 4 weeks before the first dose of study drug or intend to receive a live vaccine during the study.
  • Diagnosis or evidence of spinal cord compression or leptomeningeal carcinomatosis.
  • Uncontrolled or clinically significant cardiovascular and cerebrovascular diseases.
  • A history of non-infectious interstitial lung disease (ILD)/pneumonitis that requires steroids, current active ILD/pneumonitis.
  • Have clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses.
  • Uncontrolled third-space fluid that requires repeated drainage.
  • Digestive system disease that may cause bleeding, perforation, jaundice, fistula, GI obstruction within 6 months prior to the first dose of study drug administration or have active inflammatory bowel disease.
  • An active tuberculosis based on medical history.
  • Known human immunodeficiency virus (HIV) infection.
  • Active hepatitis C infection.
Sources for eligibility
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  • Mayo Clinic ArizonaPhoenix, United StatesRecruiting
  • UCLA Hematology/Oncology - Santa MonicaSanta Monica, United StatesRecruiting
  • Yale Cancer CenterNew Haven, United StatesRecruiting
  • The University of Kansas Cancer Center (KUCC)Kansas City, United StatesRecruiting
  • Karmanos Cancer InstituteDetroit, United StatesRecruiting
  • Columbia University Irving Medical CenterNew York, United StatesRecruiting
  • Duke University Medical Center (DUMC)Durham, United StatesRecruiting
  • University of Cincinnati Medical CenterCincinnati, United StatesRecruiting
  • Cleveland Clinic Taussig Cancer InstituteCleveland, United StatesRecruiting
  • The University of Texas MD Anderson Cancer CenterHouston, United StatesRecruiting
  • UT Health San Antonio - Mays Cancer CenterSan Antonio, United StatesRecruiting
  • University of Wisconsin Health - UW Carbone Cancer CenterMadison, United StatesRecruiting
  • Peking Union Medical College HospitalBeijing, ChinaRecruiting
  • The Sixth Affiliated Hospital of Sun Yat-sen UniversityGuangzhou, ChinaNot yet recruiting
  • Harbin Medical University Cancer HospitalHarbin, ChinaRecruiting
  • The First Affiliated Hospital of Nanchang UniversityNanchang, ChinaNot yet recruiting
  • The First Affiliated Hospital of China Medical UniversityShenyang, ChinaNot yet recruiting
  • Cancer Hospital of Shandong First Medical UniversityJinan, ChinaRecruiting
  • Ruijin Hospital, Shanghai Jiaotong University School of MedicineShanghai, ChinaRecruiting
  • Tianjin Medical University Cancer Institute & HospitalTianjin, ChinaRecruiting
  • Zhejiang Cancer HospitalHangzhou, ChinaRecruiting
Sources for sites
clinicaltrials.gov

Related records

Drugs (3)

Lead sponsors (1)

Conditions (1)

Targets (2)