This is a Phase I open-label study that will evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of HWS116 monotherapy in patients with advanced solid tumors.
Aged ≥18 years at the time of signing the Informed Consent Form (ICF);
Patients with recurrent or metastatic solid tumors confirmed by histology or cytology, who have progressed or developed intolerance after System Organ Class (SOC), or have no SOC available, or are not suitable for SOC, including but not limited to colorectal cancer, gastric cancer, esophageal cancer, pancreatic cancer, and cholangiocarcinoma;
According to the Response Evaluation Criteria In Solid Tumors (RECIST) 1.1, there is at least one evaluable lesion or one measurable target lesion；
Life expectancy ≥ 12 weeks;
Known allergy to the investigational product, drugs of the same class, or any excipients;
Have previously received any Fibroblast Growth Factor- Fibroblast Growth Factor Receptor (FGF-FGFR) pathway inhibitor;
For previous anti-tumor therapies (including investigational products/treatments): those who have received chemotherapy, small molecule targeted therapy, endocrine therapy, herbal medicine therapy/physiotherapy within 14 days prior to the first dose or within at least 5 half-lives of the corresponding drug, whichever is longer; or those who have undergone surgery (excluding diagnostic procedures such as needle biopsy), radiotherapy (palliative radiation for non-target lesions is within 14 days prior to the first dose), biotherapy, immunotherapy, or other anti-tumor therapies within 28 days prior to the first dose or within at least 5 half-lives of the corresponding drug, whichever is longer;
Have undergone major surgery within 28 days prior to the first dose;
Sequential
HWS116 Injection
DrugAdministered intravenous infusion at pre-specified doses every two weeks.
Incidence of Treatment-Emergent Adverse Events (Part 1 Only)
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (Part 2 Only)
Pharmacokinetic Parameter: Maximum Plasma Concentration (Cmax)
Pharmacokinetic Parameter: Area under the Concentration-Time Curve (AUC0-t)
Pharmacokinetic Parameter: Area under the Concentration-Time Curve (AUC0-∞)
Pharmacokinetic Parameter: Steady-State Peak Concentration (Cmax,ss)
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