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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
414
Part 1: YL202 and Toripalimab will be administered intravenously. Part 3: participants will receive escalating doses of YL202 and fixed dose of Toripalimab until YL202 doses for optimization are determined. Dose expansion stage: participants will receive a dose of YL202 not exceeding the maximum dose level achieved during the dose-escalation stage and fixed dose of Toripalimab
Part 2: YL202 will be administered intravenously,Furmonertinib Mesilate Tablets will be administered orally. Dose escalation stage: participants will receive escalating doses of YL202 and fixed dose of Furmonertinib Mesilate until YL202 doses for optimization are determined. Part 4: participants will receive a dose of YL202 not exceeding the maximum dose level achieved during the dose-escalation stage and fixed dose of Furmonertinib Mesilate.
Anhui Provincial Hospital(The First Affiliated Hospital of Ustc)
Nature and frequency of dose-limiting toxicity (DLT)
The purpose of DLT is to find maximum tolerated dose (MTD).
Time frame: 21 days after the first dose was administered to each subject.
Nature and frequency of adverse events (AEs)
Nature and frequency of AEs with severity is aim to evaluate the safety of YL202 combination.
Time frame: 42 days after the end of treatment (EOT).
Objective response rate (ORR)
ORR: defined as the proportion of patients who achieved a best overall response of complete response (CR) or partial response (PR).
Time frame: Up to approximately 3 years.
Characterize Pharmacokinetics (PK) parameter AUC
The area under curve: AUC is the total amount of YL217 in bloodstream after drug administration.
Time frame: Up to approximately 3 years
Characterize Pharmacokinetics (PK) parameter Cmax
Maximum concentration: The highest measured concentration of YL217 in the bloodstream.
Time frame: Up to approximately 3 years
Characterize Pharmacokinetics (PK) parameter Ctrough
Trough concentration
Time frame: Up to approximately 3 years
Characterize Pharmacokinetics (PK) parameter Tmax
Time to maximum observed concentration
Time frame: Up to approximately 3 years
Characterize Pharmacokinetics (PK) parameter CL
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Hefei, Anhui, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
NOT_YET_RECRUITINGSun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGMeizhou People's Hospital(Huangtang Hospital)Meizhou Academy of Medical Sciences
Meizhou, Guangdong, China
NOT_YET_RECRUITINGGhang xi Medical University Cancer Hospital
Nanning, Guangxi, China
NOT_YET_RECRUITINGAffiliated Hospital Of Hebei University
Baoding, Hebei, China
NOT_YET_RECRUITINGHarbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
NOT_YET_RECRUITINGAnyang Cancer Hospital
Anyang, Henan, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China
NOT_YET_RECRUITINGXiangyang Central Hospital
Xiangyang, Hubei, China
NOT_YET_RECRUITING...and 10 more locations
Clearance: defined as the amount of drug removed from the bloodstream by the body per unit of time
Time frame: Up to approximately 3 years
Characterize Pharmacokinetics (PK) parameter Vd
volume of distribution
Time frame: Up to approximately 3 years
Characterize Pharmacokinetics (PK) parameter t1/2
Half-life time:defined as the time it takes for the concentration of the drug in plasma or serum to be reduced by 50%
Time frame: Up to approximately 3 years
Immunogenicity endpoint: Incidence of anti-YL202 antibody (ADAs).
The presence of ADAs in patients treated with YL202 will be assessed to evaluate immunogenicity.
Time frame: Up to approximately 3 years