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

NCT06873542 | Completed Phase 1

• 1 other identifier: SHRC-DC05F01-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events

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

  6 months

Secondary Outcomes (7)

• PK profile of DC05F01

  From time zero up to 96 hours post-dose

• PK profile of DC05F01

  From time zero up to 96 hours post-dose

• PK profile of DC05F01

  From time zero up to 96 hours post-dose

• PK profile of DC05F01

  From time zero up to 96 hours post-dose

• PK profile of DC05F01

  From time zero up to 96 hours post-dose

Study Arms (1)

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.

Drug: DC05F01

Interventions

DC05F01 DRUG

DC05F01 capsule

DC05F01

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Participated in any other clinical trial and received an investigational drug within 4 weeks before the first dose of the study drug.
• 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).
• 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.
• 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).
• Baseline electrocardiogram (ECG) showing conduction abnormalities or active ischemia deemed clinically significant by the investigator.
• 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.
• Clinically significant gastrointestinal bleeding, bowel obstruction, or gastrointestinal perforation within 6 months before enrollment.
• Previous allogeneic hematopoietic stem cell or bone marrow transplantation, or previous solid organ transplantation, or current use of immunosuppressive drugs or anti-rejection medications.
• Need for concomitant use of strong inhibitors or inducers of Cytochrome P450 (CYP) 3A4, CYP1A2, and/or CYP2D6 during the trial.
• Positive test results for hepatitis B surface antigen, hepatitis C virus antibody, anti-human immunodeficiency virus antibody, or anti-treponema pallidum-specific antibody.
• Pregnant or breastfeeding women.
• Subjects (or their partners) who plan to conceive during the trial or within 3 months after the last dose of the study drug.
• Subjects deemed unsuitable for the trial by the investigator due to other reasons (such as abnormal laboratory test results, etc.).

Sponsors & Collaborators

• Heronova Pharmaceuticals: lead

Study Sites (2)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Shandong Cancer Hospital

Jinan, Shandong, 250117, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2025
• First Posted: March 12, 2025
• Study Start: July 8, 2022
• Primary Completion: December 7, 2022
• Study Completion: January 2, 2024
• Last Updated: March 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)