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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
990
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.
Anhui Provincial Cancer Hospital
Hefei, Anhui, China
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
The First Affiliated Hospital of USTC
Hefei, Anhui, China
The Second Hospital of Anhui Medical University
Hefei, Anhui, China
Peking University People's Hospital
Beijing, Beijing Municipality, China
Evaluate the AEs as characterized by type, frequency, severity, timing, seriousness and relationship to study treatment
Time frame: 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: 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: Time Frame: Approximately within 36 months
Characterize the PK parameter AUC
Time frame: Approximately within 36 months
Characterize the PK parameter Cmax
Time frame: Approximately within 36 months
Characterize the PK parameter Ctrough
Time frame: Approximately within 36 months
Characterize the PK parameter CL
Time frame: Approximately within 36 months
Characterize the PK parameter Vd
Time frame: Approximately within 36 months
Characterize the PK parameter t1/2
Time frame: Approximately within 36 months
Assess the incidence of anti-YL201 antibodies
Time frame: Approximately within 36 months
Evaluate the disease control rate (DCR) for patients assessed using RECIST version 1.1
Approximately within 36 months
Time frame: DCR: defined as the proportion of patients who achieved a best overall response of CR, PR or stable disease (SD).
Evaluate the duration of response (DoR) for patients assessed using RECIST version 1.1
Approximately within 36 months
Time frame: 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.
Evaluate the time to response (TTR) for patients assessed using RECIST version 1.1
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).
Time frame: Approximately within 36 months
Evaluate the progression-free survival (PFS) for patients assessed using RECIST version 1.1
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.
Time frame: Approximately within 36 months
Evaluate the overall survival (OS) for patients
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.
Time frame: Approximately within 36 months
Evaluate the radiographic progression-free survival (rPFS) for patients with prostate cancer
Time frame: Approximately within 36 months
Evaluate the time to PSA progression (TTPP) for patients with prostate cancer
Defined as the time from the first investigational drug administration to the first recording of PSA progression.
Time frame: Approximately within 36 months
Evaluate the PSA duration of response (PDoR) for patients with prostate cancer
Defined as the time from PSA reduction of ≥50% compared with baseline to PSA progression.
Time frame: Approximately within 36 months
Evaluate the best PSA response for patients with prostate cancer
Defined as the maximum percentage of PSA changes at any time during the study.
Time frame: Approximately within 36 months
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Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Dongguan People's Hospital
Dongguan, Guangdong, China
The Frist People's Hospital of Foshan
Foshan, Guangdong, China
...and 42 more locations