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
Informed of the study before the start of the study and voluntarily sign their name and date in the informed consent form (ICF)
Able and willing to comply with protocol visits and procedures
Aged between 18 to 75 years
Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
With prior drug therapy targeting HER3 (including antibodies, antibody-drug conjugates [ADCs]), chimeric antigen receptor T-cell immunotherapy (CAR-T), and other drugs).
Previously intolerant to topoisomerase I inhibitors or ADC therapy composed of topoisomerase I inhibitors.
Are participating in another clinical study, unless it is an observational (non-interventional) clinical study or in the follow-up period of an interventional study.
The washout period from the previous anti-tumor therapy is insufficient before the first dose of the investigational product.
Single group
YL202 for injection; Toripalimab injection
DrugPart 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
YL202 for injection; Furmonertinib Mesilate Tablets
DrugPart 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.
Nature and frequency of dose-limiting toxicity (DLT)
The purpose of DLT is to find maximum tolerated dose (MTD).
Nature and frequency of adverse events (AEs)
Nature and frequency of AEs with severity is aim to evaluate the safety of YL202 combination.
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).
Characterize Pharmacokinetics (PK) parameter AUC
The area under curve: AUC is the total amount of YL217 in bloodstream after drug administration.
Characterize Pharmacokinetics (PK) parameter Cmax
Maximum concentration: The highest measured concentration of YL217 in the bloodstream.
Characterize Pharmacokinetics (PK) parameter Ctrough
Trough concentration
Click on the lead sponsor to view all of their trials.
