This study is an open-label, dose-escalation, multicenter Phase I/II study conducted in patients with advanced solid tumors. The target population for this study consists of patients with advanced solid tumors who have failed or are intolerant to standard treatments. The study is divided into two parts: the dose-escalation phase and the dose-expansion phase.
Dose escalation phase: Subjects with advanced and/or metastatic malignant solid tumors who have failed standard treatment or lack effective standard treatment, and have histologically or cytologically confirmed diagnosis.
The subject must be ≥ 18 years of age at the time of signing the informed consent.
At least one measurable lesion according to RECIST 1.1 criteria (applicable to the backfill cohort and dose expansion phase).
Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1.
Individuals who have had an allergic reaction to any component of the XNW34017.
Subjects with double primary malignant tumors, except for the specific cancer being studied in this trial and any previously cured local tumors: non-invasive basal cell carcinoma or squamous cell carcinoma, non-invasive superficial bladder cancer, and any other tumors with a complete remission (CR) lasting more than 5 years.
Receiving a live vaccine within 4 weeks prior to the first study drug treatment. Note: Seasonal flu vaccines are generally inactivated vaccines and can be used; however, intranasal flu vaccines, which are live attenuated vaccines, are not permitted.
Use of granulocyte colony-stimulating factor (G-CSF) or granulocyte/macrophage colony-stimulating factor within 1 week prior to the first study drug treatment, or use of pegylated G-CSF within 2 weeks prior to the first study drug treatment. Receiving blood transfusion treatment within 2 weeks prior to the first study drug treatment. Use of erythropoietin (EPO) or IL-11 within 1 week prior to the first study drug treatment.
Single group
XNW34017
DrugDrug Name: XNW34017 Tablets Dosage Form: Tablet Strength: 5 mg, 50 mg Route of Administration: Oral Storage Instructions: Store in a sealed container, protected from light, at temperatures not exceeding 30°C.
The incidence and severity of AEs and SAEs
The incidence and severity of AEs and SAEs
ORR
ORR assessed by investigator
Plasma concentrations of XNW34017
Plasma concentrations of XNW34017
DCR
Disease control rate (DCR)
DOR
Duration of Response (DOR)
PFS
Progression Free Survival (PFS)
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This trial is not recruiting at the moment. You can still explore other options:
