A Study of YL202 in Combination With Other Anti-tumor Therapies in Patients With Advanced Solid Tumors

NCT07169994
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Phase
Phase 1/Phase 2
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Recruitment status
Recruiting
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Participants
414
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Lead sponsor
MediLink Therapeutics (Suzhou) Co., Ltd.
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Start date
2025-09-02
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Number of sites
20
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Summary
This is a multicenter, open-label, phase Ib/II study of YL202 in combination with other anti-tumor therapies to Evaluate the Safety, Tolerability, and Efficacy in Patients with Advanced Solid Tumors
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Short title
A Study of YL202 in Combination With Other Anti-tumor Therapies in Patients With Advanced Solid Tumors
clinicaltrials.gov
Official title
A Multi-center, Open-Label, Phase Ib/II Study of YL202 in Combination With Anti-tumor Therapy to Evaluate the Safety, Tolerability, and Efficacy 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/Phase 2
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Study type
Interventional
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Completion date
2027-11-30
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First posted
2025-09-12
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Registry last updated
2025-09-12
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Primary completion date
2026-09-01
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Start date
2025-09-02
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Participants
414
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Participant count basis
Estimated
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Planned participants
414
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Protocol amendments
0
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Number of sites
20
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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
NCT07169994
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ClinicalTrials.gov ID
NCT07169994
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Registry record
Open registry record
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Allocation
Not randomised
Model
Single group
Purpose
Treatment
Masking
No masking
Sources for study design
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  1. Nature and frequency of dose-limiting toxicity (DLT)

    Timeframe: 21 days after the first dose was administered to each subject.

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

  2. Nature and frequency of adverse events (AEs)

    Timeframe: 42 days after the end of treatment (EOT).

    Nature and frequency of AEs with severity is aim to evaluate the safety of YL202 combination.

  1. 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).

  2. 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.

  3. Characterize Pharmacokinetics (PK) parameter Cmax

    Timeframe: Up to approximately 3 years

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

  4. Characterize Pharmacokinetics (PK) parameter Ctrough

    Timeframe: Up to approximately 3 years

    Trough concentration

  5. Characterize Pharmacokinetics (PK) parameter Tmax

    Timeframe: Up to approximately 3 years

    Time to maximum observed concentration

  6. 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

  7. Characterize Pharmacokinetics (PK) parameter Vd

    Timeframe: Up to approximately 3 years

    volume of distribution

  8. 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%

  9. Immunogenicity endpoint: Incidence of anti-YL202 antibody (ADAs).

    Timeframe: Up to approximately 3 years

    The presence of ADAs in patients treated with YL202 will be assessed to evaluate immunogenicity.

Sources for outcomes
clinicaltrials.gov

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

  1. Informed of the study before the start of the study and voluntarily sign their name and date in the informed consent form (ICF)
  2. Able and willing to comply with protocol visits and procedures
  3. Aged between 18 to 75 years
  4. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
  5. Previously treated by standard treatment or have not been treated for metastatic setting;
  6. Adequate organ and bone marrow function.
  7. Have at least 1 extracranial measurable tumor lesion.
  8. Adequate archival formalin-fixed paraffin embedded （FFPE） tissue from prior biopsy.

  1. With prior drug therapy targeting HER3 (including antibodies, antibody-drug conjugates [ADCs]), chimeric antigen receptor T-cell immunotherapy (CAR-T), and other drugs).
  2. Previously intolerant to topoisomerase I inhibitors or ADC therapy composed of topoisomerase I inhibitors.
  3. Are participating in another clinical study, unless it is an observational (non-interventional) clinical study or in the follow-up period of an interventional study.
  4. The washout period from the previous anti-tumor therapy is insufficient before the first dose of the investigational product.
  5. Patients who have received major surgery (excluding diagnostic surgery) within 4 weeks before the first dose of the investigational product or those who are expected to receive major surgery during the study.
  6. Prior treatment with allogeneic bone marrow transplantation or solid organ transplantation.
  7. Prior treatment with systemic steroids (prednisone > 10 mg/day or equivalent) or other immunosuppressive treatment within 2 weeks before the first dose of the investigational product.
  8. Patients who have received any live vaccine within 4 weeks before the first dose of the investigational product or those who plan to receive live vaccine during the study period.
  9. With meningeal metastasis or cancerous meningitis.
  10. With brain metastasis or spinal cord compression.
  11. Patients with uncontrolled or clinically significant cardiovascular diseases.
  12. Clinically significant complicated pulmonary disorders.
  13. Patients diagnosed with Gilbert syndrome.
  14. Those with uncontrolled effusion in the third space requiring repeated drainage.
  15. With a medical history of gastrointestinal perforation and/or fistula within 6 months before the first dose, or with active gastric and duodenal ulcers, ulcerative colitis, or other gastrointestinal diseases that may lead to hemorrhage or perforation according to the investigator.
  16. With serious infection before the first dose.
  17. With known human immunodeficiency virus (HIV) infection.
  18. With active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
  19. With a medical history of any other primary malignancies within 5 years before the first dose of the investigational product.
  20. Unrelieved toxicity of previous anti-tumor therapy.
  21. With a history of severe hypersensitivity to inactive ingredients in the raw materials and drug product or other monoclonal antibodies.
  22. Lactating women, or women who are confirmed pregnant via a pregnancy test within 3 days before the first dose.
  23. With any diseases, medical conditions, organ system dysfunction, or social conditions that may interfere with the ability of subjects to sign the ICF, adversely affect the ability of subjects to cooperate and participate in the study, or affect the interpretation of study results, including but not limited to mental illness or substance/alcohol abuse, in the opinion of the investigator.
Sources for eligibility
clinicaltrials.gov

  • Anhui Provincial Hospital(The First Affiliated Hospital of Ustc)Hefei, ChinaNot yet recruiting
  • Fujian Cancer HospitalFuzhou, ChinaNot yet recruiting
  • Sun Yat-sen University Cancer CenterGuangzhou, ChinaNot yet recruiting
  • Meizhou People's Hospital（Huangtang Hospital）Meizhou Academy of Medical SciencesMeizhou, ChinaNot yet recruiting
  • Ghang xi Medical University Cancer HospitalNanning, ChinaNot yet recruiting
  • Affiliated Hospital Of Hebei UniversityBaoding, ChinaNot yet recruiting
  • Harbin Medical University Cancer HospitalHarbin, ChinaNot yet recruiting
  • Anyang Cancer HospitalAnyang, ChinaNot yet recruiting
  • The First Affiliated Hospital of Henan University of Science and TechnologyLuoyang, ChinaNot yet recruiting
  • Xiangyang Central HospitalXiangyang, ChinaNot yet recruiting
  • The First People's Hospital of Changde CityChangde, ChinaNot yet recruiting
  • Jiangsu Province Hospital（The First Affiliated Hospital With Nanjing Medical University, Jiangsu Women And Children Health Hospital)Nanjing, ChinaNot yet recruiting
  • Jiangxi Cancer HospitalNanchang, ChinaNot yet recruiting
  • Affiliated Zhongshan Hospital Dalian UniversityDalian, ChinaNot yet recruiting
  • Liaoning cancer hospital &instituteShenyang, ChinaNot yet recruiting
  • Affiliated Zhongshan Hospital Dalian UniversityJinan, ChinaNot yet recruiting
  • Fudan University Shanghai Cancer CenterShanghai, ChinaRecruiting
  • Shanxi Cancer HospitalTaiyuan, ChinaNot yet recruiting
  • Sichuan Academy of Medical Sciences&Sichuan Provincial People's HospitalSichuan, ChinaNot yet recruiting
  • Tianjin Cancer Hospital Airport HospitalTianjin, ChinaNot yet recruiting
Sources for sites
clinicaltrials.gov

Related records

Drugs (3)

Lead sponsors (1)

Conditions (3)

Targets (1)