Advanced Esophageal Squamous Cell Carcinoma
Conditions
Brief summary
This is a large clinical study carried out at multiple hospitals. Participants will be randomly assigned to one of two groups: one group will receive a new medicine called YL201, and the other group will receive standard chemotherapy chosen by the doctor. The purpose of the study is to see whether YL201 works better and is safer for people with locally advanced or metastatic esophageal squamous cell carcinoma whose first-line treatment has stopped working. The study will also look at how YL201 is processed in the body (Pharmacokinetics), whether it triggers any immune reactions, and whether certain biological markers can help predict how well it works.
Interventions
DRUGYL201
YL201, a B7H3 targeting ADC，administered on Day 1 of each cycle, intravenous infusion, every 3 weeks (Q3W).
DRUGPaclitaxel
175 mg/m², administered on Day 1 of each cycle, intravenous infusion, every 3 weeks (Q3W).
DRUGDocetaxel
75 mg/m², administered on Day 1 of each cycle, intravenous infusion, every 3 weeks (Q3W).
DRUGIrinotecan
125 mg/m², administered on Days 1 and 8 of each cycle, intravenous infusion, every 3 weeks (Q3W).
Sponsors
MediLink Therapeutics (Suzhou) Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age: ≥18 years; 2. Voluntary participation in this study with signed informed consent and good compliance. 3. ECOG PS score: 0-1; 4. estimated life expectancy \>3 months; 5. Histologically or cytologically confirmed ESCC with unresectable locally advanced or metastatic disease 6. Previously received one line of systemic standard therapy for unresectable locally advanced or metastatic ESCC and experienced disease progression 7. Adequate organ function. 8. At least one measurable lesion 9. Willing to provide biopsy or archived tumor tissue.
Exclusion criteria
1. Other malignancies within 5 years prior to first dose or currently concurrent malignancies. 2. Prior treatment-related adverse events not resolved to ≤Grade 1 per CTCAE v5.0, except for alopecia (any grade), hyperpigmentation (any grade), peripheral neuropathy (≤ Grade 2), and lymphopenia (≤ Grade 3). 3. Major surgery, significant traumatic injury within 4 weeks prior to first dose, or anticipated need for major surgery during study treatment 4. Any arterial thromboembolic event within 6 months prior to randomization, or venous thromboembolic events of Grade ≥ 3 according to NCI CTCAE version 5.0. 5. Known active tuberculosis (TB). Participants suspected of having active TB must undergo clinical evaluation to rule it out. 6. History of immunodeficiency or positive test for human immunodeficiency virus (HIV) antibodies. Participants with known active syphilis infection are also excluded. 7. Current active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV). 8. Known allergy to any component of the investigational product; history of severe allergic reactions (e.g., anaphylactic shock); or known history of severe hypersensitivity reactions to other monoclonal antibodies or recombinant proteins, or previous severe infusion reactions. 9. Women who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study period. 10. Any disease, medical condition, organ dysfunction, or social/psychological circumstance that, in the investigator's judgment, may interfere with the participant's ability to sign the informed consent form (ICF), compromise cooperation or compliance with study procedures, or affect the interpretation of study results. This includes, but is not limited to, psychiatric disorders, substance/alcohol abuse, or a history of drug abuse.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | Up to Approximately 36 Months | OS is defined as the time from randomization to the event of death from any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) | Up to Approximately 36 Months | PFS is defined as the time from randomization to the first occurrence of radiographic progression based on RECIST version 1.1 as determined by investigator or death from any cause, whichever occurs earlier. |
| Overall response rate (ORR) | Up to Approximately 36 Months | ORR is defined as the proportion of participants achieving a best overall response of confirmed Complete response (CR) or confirmed partial response (PR) as determined by investigator based on RECIST version 1.1. |
| Disease control rate (DCR) | Up to Approximately 36 Months | DCR is defined as the proportion of participants with complete response (CR), partial response (PR), or disease stabilization (SD) as determined by the investigator according to RECIST 1.1. |
| Duration of Response (DOR) | Up to Approximately 36 Months | DOR is defined as the time interval from the date of first documentation of objective response (CR or PR) to date of the first documentation of disease progression as determined by the investigator according to RECIST v1.1, or death due to any cause, whichever occurs first. |
| Adverse Event (AE) | Up to Approximately 36 Months | The incidence and severity of adverse events, with severity graded according to the NCI CTCAE v5.0 scale. |
Countries
China
Contacts
CONTACTMedilink Study Team
Outcome results
None listed