A Study YL201 in Patients With Selected Advanced Solid Tu... | NCT06057922

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Phase 1 dose expansion stage	Experimental	Patients will be treated with YL201 intravenous (IV) infusion once every 3 weeks (Q3W) as a cycle; and at dose levels of 1.0 mg/kg and 1.2 mg/kg administered on Days 1 and 8 of each Q3W treatment cycle.	Drug: YL201 for Injection
Phase 2 stage with expanded sample size	Experimental	Patients will be treated with YL201 intravenous (IV) infusion at PR2D once every 3 weeks (Q3W) as a cycle; and at dose levels of 1.0 mg/kg and 1.2 mg/kg administered on Days 1 and 8 of each Q3W treatment cycle.	Drug: YL201 for Injection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
YL201 for Injection	Drug	Patients will be treated with YL201 intravenous (IV) infusion once every 3 weeks (Q3W) as a cycle; and at dose levels of 1.0 mg/kg and 1.2 mg/kg administered on Days 1 and 8 of each Q3W treatment cycle.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluate the AEs as characterized by type, frequency, severity, timing, seriousness and relationship to study treatment		By the global end of trial date, approximately within 36 months
Evaluate the objective response rate (ORR) for patients with solid tumors which assessed using RECIST version 1.1	ORR: defined as the proportion of patients who achieved a best overall response of complete response (CR) or partial response (PR).	Time Frame: Approximately within 36 months
Evaluate the prostate-specific antigen (PSA) response rate for patients with prostate cancer	PSA response rate: defined as the proportion of patients who achieved a ≥50% decrease in PSA from baseline	Time Frame: Approximately within 36 months

Secondary Outcomes

Measure	Description	Time Frame
Characterize the PK parameter AUC		Approximately within 36 months
Characterize the PK parameter Cmax		Approximately within 36 months
Characterize the PK parameter Ctrough

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Facility	Status	City	State	ZIP	Country	Contacts
Anhui Provincial Cancer Hospital		Hefei	Anhui		China
The First Affiliated Hospital of Anhui Medical University

ID	Term
D004333	Drug Administration Routes
D004358	Drug Therapy
D013812	Therapeutics