A Study YL201 in Patients With Selected Advanced Solid Tumors

NCT06057922
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Phase
Phase 1/Phase 2
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Recruitment status
Active, not recruiting
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Participants
990
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Lead sponsor
MediLink Therapeutics (Suzhou) Co., Ltd.
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Start date
2023-09-22
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Number of sites
52
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Summary
This is A Multicenter, Open-Label, Phase 1/2 Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of YL201 in Patients with Selected Advanced Solid Tumors. The study will include 2 parts: Phase 1 dose expansion stage (Part 1) followed by a Phase 2 stage with expanded sample size (Part 2). Part 1 will estimate the RP2D in dose expansion cohorts of patients with not linited to non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), nasopharyngeal carcinoma (NPC), esophageal squamous cell carcinoma (ESCC), metastatic castration-resistant prostate cancer (mCRPC), head and neck squamous cell carcinoma (HNSCC), sarcoma, ductal adenocarcinoma of pancreas (PDAC), hepatocellular carcinoma (HCC), biliary tract cancer (BTC), etc.. Part 2 will include patients with selected advanced solid tumor types enrolled at the RP2D to further assess the efficacy and safety of YL201.
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Short title
A Study YL201 in Patients With Selected Advanced Solid Tumors
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Official title
A Multicenter, Open-Label, Phase 1/2 Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of YL201 in Patients With Selected 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
Active, not recruiting
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Phase
Phase 1/Phase 2
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Study type
Interventional
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Completion date
2028-10-01
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First posted
2023-09-28
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Registry last updated
2026-03-12
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Primary completion date
2026-10-01
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Start date
2023-09-22
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Participants
990
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Participant count basis
Estimated
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Planned participants
990
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Protocol amendments
1
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Number of sites
52
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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
NCT06057922
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ClinicalTrials.gov ID
NCT06057922
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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
clinicaltrials.gov

  1. Evaluate the AEs as characterized by type, frequency, severity, timing, seriousness and relationship to study treatment

    Timeframe: By the global end of trial date, approximately within 36 months

  2. Evaluate the objective response rate (ORR) for patients with solid tumors which assessed using RECIST version 1.1

    Timeframe: Time Frame: Approximately within 36 months

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

  3. Evaluate the prostate-specific antigen (PSA) response rate for patients with prostate cancer

    Timeframe: Time Frame: Approximately within 36 months

    PSA response rate: defined as the proportion of patients who achieved a ≥50% decrease in PSA from baseline

  1. Characterize the PK parameter AUC

    Timeframe: Approximately within 36 months

  2. Characterize the PK parameter Cmax

    Timeframe: Approximately within 36 months

  3. Characterize the PK parameter Ctrough

    Timeframe: Approximately within 36 months

  4. Characterize the PK parameter CL

    Timeframe: Approximately within 36 months

  5. Characterize the PK parameter Vd

    Timeframe: Approximately within 36 months

  6. Characterize the PK parameter t1/2

    Timeframe: Approximately within 36 months

  7. Assess the incidence of anti-YL201 antibodies

    Timeframe: Approximately within 36 months

  8. Evaluate the disease control rate (DCR) for patients assessed using RECIST version 1.1

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

    Approximately within 36 months

  9. Evaluate the duration of response (DoR) for patients assessed using RECIST version 1.1

    Timeframe: 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 PD. DoR will be assessed for patients with a response (CR or PR) only.

    Approximately within 36 months

  10. Evaluate the time to response (TTR) for patients assessed using RECIST version 1.1

    Timeframe: Approximately within 36 months

    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).

  11. Evaluate the progression-free survival (PFS) for patients assessed using RECIST version 1.1

    Timeframe: Approximately within 36 months

    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.

  12. Evaluate the overall survival (OS) for patients

    Timeframe: Approximately within 36 months

    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.

  13. Evaluate the radiographic progression-free survival (rPFS) for patients with prostate cancer

    Timeframe: Approximately within 36 months

  14. Evaluate the time to PSA progression (TTPP) for patients with prostate cancer

    Timeframe: Approximately within 36 months

    Defined as the time from the first investigational drug administration to the first recording of PSA progression.

  15. Evaluate the PSA duration of response (PDoR) for patients with prostate cancer

    Timeframe: Approximately within 36 months

    Defined as the time from PSA reduction of ≥50% compared with baseline to PSA progression.

  16. Evaluate the best PSA response for patients with prostate cancer

    Timeframe: Approximately within 36 months

    Defined as the maximum percentage of PSA changes at any time during the study.

Sources for outcomes
clinicaltrials.gov

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

  • Informed of the trial before the start of the trial and voluntarily sign their name and date on the ICF.
  • Age ≥18 years old and ≤75 years old
  • Histologically or cytologically confirmed at diagnosis of NSCLC/SCLC/NPC/ESCC /mCRPC/HNSCC/Sarcoma/PDAC/HCC/BTC
  • At least one extracranial measurable lesion according to RECIST 1.1.
  • Archived or fresh tumor tissue samples can be provided.
  • Eastern Cooperative Oncology Group - performance scale (ECOG PS) score of 0 or 1.
  • Female subjects with fertility must agree to take high-efficiency contraceptive measures from screening to whole study period and within at least 6 months after last administration of investigational drug. Male subjects must agree to take high-efficiency contraceptive measures from screening to whole study period and within at least 6 months after last administration of investigational drug.
  • Life expectancy ≥3 months.
  • Capable or willing to observe the visits and procedures stipulated in study protocol.

  • Prior treatment with products targeting B7H3 (including antibodies, antibody-drug conjugate [ADC], chimeric antigen receptor T cells [CAR-T], and other drugs).
  • Prior treatment with topoisomerase 1 inhibitors or ADC based on topoisomerase 1 inhibitors.
  • Participation in another clinical trial meanwhile, except observatory (non-interventional) clinical trial or at follow-up period of interventional study.
  • Washout period of previous anticancer treatment was insufficient before first administration of investigational drug.
  • Major surgery (excluding diagnostic surgery) within 4 weeks before first administration of investigational drug or likely to require major surgery during the study.
  • History of allogenic bone marrow transplantation or solid organ transplantation.
  • Treatment with systemic steroid (Prednisone >10 mg/d or equivalent drugs) or other immunosuppressive drugs within 2 weeks before first administration of investigational drug.
  • Live vaccination within 4 weeks before first administration of investigational drug or likely to require live vaccine inoculation during the study.
  • Evidence of leptomeningeal metastasis or carcinomatous meningitis.
  • Evidence of brain metastasis or spinal cord compression.
  • Evidence of cardiovascular disease with uncontrolled state or clinical significance.
  • Clinically significant concomitant lung disease.
  • Diagnosed as Gilbert syndrome.
  • Complicated with uncontrolled third-space effusion .
  • History of gastrointestinal perforation and/or fistula within 6 months before first administration.
  • History of serious infection (Grade ≥3 of NCI CTCAE) before first administration.
  • Known as infection with human immunodeficiency virus (HIV).
  • Active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV).
  • History of any other primary malignant tumor within 5 years before first administration of investigational drug.
  • The toxicity of previous anticancer treatment is not resolved.
  • History of serious hypersensitive reactions to drug substance, inactive compositions of preparations or other monoclonal antibodies.
  • Breastfeeding women. Or women confirmed as pregnant through pregnancy test within 3 days before first administration.
  • Any disease, medical state, organ/system dysfunction or social state considered by investigators as possibly interfering the subject's capability for ICF signing, producing adverse influence on the subject's capability for cooperation and study participation or influencing the interpretation of study results. Including but not limited to mental disease or substance/alcohol abuse.
Sources for eligibility
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  • Anhui Provincial Cancer HospitalHefei, China
  • The First Affiliated Hospital of Anhui Medical UniversityHefei, China
  • The First Affiliated Hospital of USTCHefei, China
  • The Second Hospital of Anhui Medical UniversityHefei, China
  • Peking University People's HospitalBeijing, China
  • Chongqing University Cancer HospitalChongqing, China
  • Fujian Cancer HospitalFuzhou, China
  • The First Affiliated Hospital of Xiamen UniversityXiamen, China
  • Dongguan People's HospitalDongguan, China
  • The Frist People's Hospital of FoshanFoshan, China
  • Sun Yat-sen University Cancer CenterGuangzhou, China
  • Affiliated Cancer Hospital and Institute of Guangzhou Medical UniversityGuangzhou, China
  • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen UniversityGuangzhou, China
  • Jiangmen Central HospitalJiangmen, China
  • Yuebei People's HospitalShaoguan, China
  • The Fifth Affiliated Hospital Sun Yat-Sen UniversityZhuhai, China
  • The Second Affiliated Hospital of Guilin Medical UniversityGuilin, China
  • Liuzhou People's HospitalLiuzhou, China
  • Liuzhou Worker's HospitalLiuzhou, China
  • Affiliated Cancer Hospital of Guangxi Medical UniversityNanning, China
  • The People's Hospital of Guangxi Zhuang Autonomous RegionNanning, China
  • The First Affiliated Hospital of Hainan Medical UniversityHaikou, China
  • Affiliated Hospital of Chengde Medical UniversityChengde, China
  • Harbin Medical University Cancer HospitalHaerbin, China
  • The First Affiliated Hospital of Henan University of Science and TechnologyLuoyang, China

And 27 more, listed on the interactive page.

Sources for sites
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Sources for references
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Related records

Drugs (1)

Lead sponsors (1)