A Phase 1/2 Study of HLX301, A Recombinant Humanized Anti-PDL1 and Anti-TIGIT Bispecific Antibody, in patients with locally advanced/metastatic solid tumors or lymphoma.Up to 150 patients will be included in this study. Up to 30 DLT evaluable patients will be enrolled in phase 1a (dose escalation), 40 per-protocol treated patients in phase 1b (dose expansion), and 80 per-protocol treated patients in phase 2. Phase 1a to evaluate safety, dose limiting toxicity (DLT), and the maximum tolerated dose (MTD) of HLX301 in patients with advanced or metastatic tumors who have failed or are intolerant to standard therapy, or for whom no standard therapy is available.Phase 1b to identify the recommended phase 2 dose (RP2D) of HLX301 in patients with advanced or metastatic NSCLC who have failed or are intolerant to standard therapy, or for whom no standard therapy is available. Phase 2 to evaluate the anti-tumor activity of HLX301 in patients with histologically or cytologically-confirmed non-small cell lung cancer (NSCLC), gastric/esophagogastric junction adenocarcinoma (GC/EGJ), head and neck squamous cell carcinoma (HNSCC), or urothelial carcinoma (UC) tumors that express PD-L1, after one or two prior systemic treatments and without standard therapy。
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
HLX301 will be administered as a single intravenous (IV) infusion on Day1 in each 14-day cycle.
Jilin Provincial Cancer Hospital
Changchun, Jilin, China
RECRUITINGShandong Cancer Hospital
Jinan, Shandong, China
RECRUITINGPhase 1a: The incidence, nature, and severity of adverse events according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 in patients receiving the trial drug
Including grading of the incidence, nature, and severity of adverse events according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Time frame: up to 2 years
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