Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This trial employs a non-randomized, open-label, dose-escalation design to evaluate the safety, tolerability, pharmacokinetic (PK) profile, and preliminary efficacy of DC05F01 in Chinese patients with advanced or metastatic solid tumors.
Subjects in each dose cohort will first undergo a single-dose study to assess safety, tolerability, and PK. PK sample collection for the single dose will be conducted over 96 hours. If safety is deemed acceptable after a 5-day observation period (Cycle 0 to Cycle 1 Day 1), subjects will proceed to the multiple-dosing study. The multiple-dosing study will consist of 4-week treatment cycles (daily dosing for 4 weeks, with blood sampling up to 96 hours after the last dose in Cycle 1) (Cycle 1 to Cycle N). The dose limiting toxicity (DLT) observation period will cover the single-dose period and the first cycle of multiple dosing (Cycle 0 + Cycle 1, Day 1 to Day 28). Following this period, subjects will continue with 4-week dosing cycles (Cycle 2 to Cycle N) until they complete six treatment cycles, experience disease progression, develop intolerable toxicity, initiate new anti-tumor therapy, withdraw consent, voluntarily withdraw, die, are lost to follow-up, or encounter other protocol-specified reasons for treatment discontinuation, whichever occurs first. The dose escalation will follow the standard "3+3" design, proceeding from the low-dose group to the high-dose group.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DC05F01 | Experimental | All enrolled subjects will receive DC05F01 orally. Doses will be escalated from low to high and are coded as Dose Group 1, 2, and 3, with corresponding dosing levels of 1200 mg, 1600 mg, and 2100 mg, respectively. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DC05F01 | Drug | DC05F01 capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | Incidence and severity of adverse events as assessed by CTCAE Version 5.0 | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| PK profile of DC05F01 | Peak Concentration (Cmax): The maximum plasma concentration of the drug. | From time zero up to 96 hours post-dose |
| PK profile of DC05F01 | Area Under the Curve from Time Zero to the Last Measurable Concentration (AUC0-t): The area under the plasma concentration-time curve from time zero to the last measurable concentration. |
Not provided
Inclusion Criteria:
Aged ≥18 years at the time of signing the informed consent form, Chinese male or female.
Patients with locally advanced or metastatic solid tumors confirmed by histology and/or cytology, who are refractory to treatment, have failed standard therapy, have no standard treatment options, or for whom standard treatment is not applicable at present.
Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
Presence of at least one measurable or evaluable tumor lesion according to RECIST 1.1 criteria.
Expected survival time of ≥3 months.
Adequate Organ Function:
Absolute Neutrophil Count (ANC) >1.5×10^9/L. Hemoglobin (HGB) ≥90 g/L. Platelets (PLT) >100×10^9/L. Total Bilirubin (TBIL) ≤1.5 mg/dL. Albumin (ALB): ≥3 g/dL. Aspartate Aminotransferase (AST)/Alanine Aminotransferase (ALT)/Alkaline Phosphatase (ALP)/Gamma-Glutamyl Transferase (GGT) ≤2.5 times the upper limit of normal (ULN). If liver metastases are present, AST/ALT/ALP < 5×ULN.
Serum Creatinine (Scr) ≤1.5×ULN or Creatinine Clearance (CrCl) ≥60 mL/min. Prothrombin Time (PT)/Activated Partial Thromboplastin Time (APTT) ≤1.5×ULN. Serum sodium, potassium, magnesium, calcium, and phosphate levels within normal range or deemed clinically insignificant by the investigator. Supplements to maintain normal electrolyte levels are permitted.
Women of childbearing potential must have a negative serum pregnancy test prior to the first dose. Women of childbearing potential are defined as those who have experienced menarche and have not undergone sterilization surgery (hysterectomy, bilateral oophorectomy, or bilateral tubal ligation) or are not postmenopausal [defined as amenorrhea for at least 12 consecutive months at an appropriate age (e.g., >45 years) with certain clinical manifestations].
Men and women of reproductive potential must agree to use reliable contraceptive measures throughout the study period.
Ability to understand and voluntarily sign the informed consent form, and willingness to comply with the study's dosing regimen and visit schedule.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Beijing | Beijing Municipality | 100142 | China | ||
| Shandong Cancer Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| From time zero up to 96 hours post-dose |
| PK profile of DC05F01 | Area Under the Curve from Time Zero Extrapolated to Infinity (AUC0-∞): The area under the plasma concentration-time curve from time zero extrapolated to infinity. | From time zero up to 96 hours post-dose |
| PK profile of DC05F01 | Time to Reach Peak Concentration (Tmax): The time at which the peak plasma concentration is reached. | From time zero up to 96 hours post-dose |
| PK profile of DC05F01 | Elimination Half-Life (T1/2): The time required for the plasma concentration to decrease by half. | From time zero up to 96 hours post-dose |
| Overall response rate (ORR) | Overall response rate (ORR) based on RECIST v1.1 as assessed by the investigator | Up to 6 months |
| Progression-free Survival (PFS) | Progression-free survival (PFS) based on RECIST v1.1 as assessed by the investigator | Up to 6 months |
| Jinan |
| Shandong |
| 250117 |
| China |