Solid TumorsPhase 1NCT06873542
A Study of DC05F01 in Chinese Patients with Advanced or Metastatic Solid Tumors
A Phase 1 study testing DC05F01 in people with Solid Tumors, run by Heronova Pharmaceuticals at 2 sites in China.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- DC05F01
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesChina
- Study dates
- 8 Jul 2022to 2 Jan 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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.
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- 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.).
Trial locations and contacts
2 sites in 1 country.
China2 sites
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Shandong Cancer Hospital
Jinan, Shandong, 250117
About this study
Official title: An Open-Label, Dose-Escalation Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile, and Preliminary Efficacy of DC05F01 in Chinese Patients with Advanced or Metastatic Solid Tumors
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.
- Conditions
- Solid Tumors
- Being tested
- DC05F01
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DC05F01Drug
DC05F01 capsule
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: DC05F01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events
Incidence and severity of adverse events as assessed by CTCAE Version 5.0
Measured: 6 months
Secondary outcomes (7)
PK profile of DC05F01
Peak Concentration (Cmax): The maximum plasma concentration of the drug.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Up to 6 months
Progression-free Survival (PFS)
Progression-free survival (PFS) based on RECIST v1.1 as assessed by the investigator
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study start8 Jul 2022
- Primary completion7 Dec 2022
- Study completion2 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heronova Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06873542
- Sponsor's protocol ID
- SHRC-DC05F01-01
- Status last verified
- Feb 2025
- First submitted
- 7 Mar 2025
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Dose-Escalation Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile, and Preliminary Efficacy of DC05F01 in Chinese Patients with Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT06873542
- Acronym / sponsor ID
- SHRC-DC05F01-01
- Conditions
- Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Heronova PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 8 Jul 2022 (actual)
- Primary completion
- 7 Dec 2022 (actual)
- Study completion
- 2 Jan 2024 (actual)
- First posted
- 12 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DC05F01 | Experimental | Drug: DC05F01All 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (14 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DC05F01DC05F01 capsule | Drug | DC05F01 |
Primary outcome
Number of Participants With Adverse Events
Time frame: 6 months
Incidence and severity of adverse events as assessed by CTCAE Version 5.0
7 secondary outcomes
PK profile of DC05F01
Time frame: From time zero up to 96 hours post-dose
PK profile of DC05F01
Time frame: From time zero up to 96 hours post-dose
PK profile of DC05F01
Time frame: From time zero up to 96 hours post-dose
PK profile of DC05F01
Time frame: From time zero up to 96 hours post-dose
PK profile of DC05F01
Time frame: From time zero up to 96 hours post-dose
Overall response rate (ORR)
Time frame: Up to 6 months
Progression-free Survival (PFS)
Time frame: Up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DC05F01 in people with Solid Tumors, run by Heronova Pharmaceuticals at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.