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CompletedNCT06873542Updated Mar 12, 2025

A Study of DC05F01 in Chinese Patients with Advanced or Metastatic Solid Tumors

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

From the registry’s dates

  • Registered 2 years 7 months after the study started (first participant enrolled Jul 2022, registered Mar 2025).
Phase
Phase 1
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Solid Tumors

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03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 10 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.

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Lead sponsor

Heronova Pharmaceuticals is the lead sponsor of 6 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Aged ≥18 years at the time of signing the informed consent form, Chinese male or female.
  2. 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.
  3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
  4. Presence of at least one measurable or evaluable tumor lesion according to RECIST 1.1 criteria.
  5. Expected survival time of ≥3 months.
  6. 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.

  7. 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].
  8. Men and women of reproductive potential must agree to use reliable contraceptive measures throughout the study period.
  9. 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

Exclusion Criteria:

  1. Received chemotherapy, radiotherapy, or other anti-tumor treatments within 4 weeks or 5 half-lives (whichever is shorter) before the first dose of the study drug. For nitrosoureas or mitomycin C, this period is extended to 6 weeks.
  2. Participated in any other clinical trial and received an investigational drug within 4 weeks before the first dose of the study drug.
  3. Adverse effects related to prior chemotherapy, radiotherapy, biological agents, hormonal therapy, or previous investigational treatments have not resolved to ≤Grade 1 (except for alopecia or neurotoxicity of Grade 1-2).
  4. Presence of untreated brain metastases or treated brain metastases that have not achieved radiological and clinical stability (i.e., requiring steroid treatment) within 4 weeks before enrollment.
  5. Baseline QT/QTc interval prolongation deemed clinically significant by the investigator (calculated using Fridericia's formula, QTc interval >470 ms for females, >450 ms for males).
  6. Baseline electrocardiogram (ECG) showing conduction abnormalities or active ischemia deemed clinically significant by the investigator.
  7. Presence of uncontrolled or unstable comorbid conditions before enrollment, including but not limited to persistent or active infections, symptomatic congestive heart failure, hypertension, unstable angina, arrhythmias, autoimmune or inflammatory diseases, psychiatric/social disorders, and other conditions that may affect trial compliance as judged by the investigator.
  8. Clinically significant gastrointestinal bleeding, bowel obstruction, or gastrointestinal perforation within 6 months before enrollment.
  9. Previous allogeneic hematopoietic stem cell or bone marrow transplantation, or previous solid organ transplantation, or current use of immunosuppressive drugs or anti-rejection medications.
  10. Need for concomitant use of strong inhibitors or inducers of Cytochrome P450 (CYP) 3A4, CYP1A2, and/or CYP2D6 during the trial.
  11. Positive test results for hepatitis B surface antigen, hepatitis C virus antibody, anti-human immunodeficiency virus antibody, or anti-treponema pallidum-specific antibody.
  12. Pregnant or breastfeeding women.
  13. Subjects (or their partners) who plan to conceive during the trial or within 3 months after the last dose of the study drug.
  14. Subjects deemed unsuitable for the trial by the investigator due to other reasons (such as abnormal laboratory test results, etc.).
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    DC05F01

    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

Interventions

  • DrugDC05F01

    DC05F01 capsule

06

What researchers measure

Primary outcomes

  1. Number of Participants With Adverse Events

    Incidence and severity of adverse events as assessed by CTCAE Version 5.0

    Time frame: 6 months

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. Overall response rate (ORR)

    Overall response rate (ORR) based on RECIST v1.1 as assessed by the investigator

    Time frame: Up to 6 months

  7. Progression-free Survival (PFS)

    Progression-free survival (PFS) based on RECIST v1.1 as assessed by the investigator

    Time frame: Up to 6 months

07

Study locations

2 sites
  • Beijing Cancer Hospital
    Beijing, Beijing 100142, China
  • Shandong Cancer Hospital
    Jinan, Shandong 250117, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 12, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06873542
Lead sponsor
Heronova Pharmaceuticals
Responsible party
Sponsor
First posted
Mar 12, 2025
Start date
Jul 8, 2022
Primary completion
Dec 7, 2022
Completion
Jan 2, 2024
Last update
Mar 12, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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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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