A Phase 1 interventional study of DC05F01 in Solid Tumors, sponsored by Heronova Pharmaceuticals. Completed at 2 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-12.
Sponsored by Heronova Pharmaceuticals · Phase 1, Interventional, and Treatment
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.
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This study's enrollment of 10 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.
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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.
Exclusion Criteria:
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.
Drug: DC05F01
DC05F01 capsule
Number of Participants With Adverse Events
Incidence and severity of adverse events as assessed by CTCAE Version 5.0
Time frame: 6 months
PK profile of DC05F01
Peak Concentration (Cmax): The maximum plasma concentration of the drug.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Up to 6 months
Progression-free Survival (PFS)
Progression-free survival (PFS) based on RECIST v1.1 as assessed by the investigator
Time frame: Up to 6 months
Plan to share: No
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This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Heronova Pharmaceuticals