Solid TumorsPhase 1/2NCT06873555
A Study of DC05F01 in Chinese Patients With Recurrent/Refractory Ovarian Cancer and Other Advanced Solid Tumors
A Phase 1/2 study testing DC05F01 in people with Solid Tumors and Ovarian Cancer, run by Heronova Pharmaceuticals at 2 sites in China.
Trial summary
This study is a multicenter, open-label, cohort expansion Phase Ib/IIa trial designed to evaluate the efficacy, safety, and pharmacokinetic (PK) profile of DC05F01 in patients with recurrent/refractory ovarian cancer and other advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors, Ovarian Cancer, Small Cell Lung Cancer
- 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
- 60 participants
- Where
- 2 sitesChina
- Study dates
- 11 Sep 2024to Dec 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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
- Voluntarily signed the informed consent form, understanding the study and willing to follow and capable of completing all trial procedures.
- Aged ≥18 years, regardless of gender.
- Patients with locally advanced or metastatic disease, including:
- Cohort 1: Epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer with FIGO stage III-IV, previously treated with platinum-based therapy and experienced disease progression or recurrence during or within 6 months (184 calendar days) after the last platinum-based treatment.
- Cohort 2: Limited-stage small cell lung cancer patients, as staged by the Veterans Administration Lung Study Group (VALG), who are not surgical candidates and have not progressed during or after at least 4 cycles of platinum-based chemotherapy combined with concurrent or sequential radiotherapy, completed within 6 weeks before the first dose.
- Cohort 3: Other solid tumors that have failed standard treatment, have no standard treatment options, or for whom standard treatment is not applicable at present.
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- Cohort 1: Patients must have undergone initial or interval debulking surgery. Elevated CA125 alone without radiological or clinical evidence cannot be considered as disease progression or recurrence. Prior treatment may include bevacizumab and PARP inhibitors.
- Cohort 2: Chemotherapy regimens must include platinum agents and intravenous etoposide, followed by a radical radiotherapy regimen. Prophylactic cranial irradiation is allowed based on the investigator's judgment and local standard of care, completed within 6 weeks before the first dose.
- According to RECIST 1.1 criteria, there must be at least one measurable lesion assessed by imaging (lesions within previously irradiated areas or treated with other local therapies are generally not considered measurable unless there is documented progression) (applicable to Cohort 1 and Cohort 3).
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
- Expected survival time of ≥3 months.
- No significant hematologic, hepatic, renal, coagulation, or cardiac function abnormalities. Laboratory test results during the screening period (no transfusions or hematopoietic growth factor support within 14 days before testing) must meet the following standards:
- 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.
- Male subjects and women of childbearing potential must agree to use effective contraception from the time of signing the informed consent form until 3 months after the last dose of the study drug. Women of childbearing potential must have a negative serum pregnancy test prior to the first dose of the study drug.
Who cannot join
- Received chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy, or other anti-tumor treatments within 4 weeks or 5 half-lives (whichever is shorter) before the first dose of the study drug, except for:
- Nitrosoureas or mitomycin C within 6 weeks before the first dose. Oral fluorouracil or small-molecule targeted drugs within 2 weeks or 5 half-lives (whichever is shorter) before the first dose.
- Anti-tumor traditional Chinese medicine within 2 weeks before the first dose.
- Received any other investigational drug or treatment in another clinical trial within 4 weeks before the first dose.
- Underwent major organ surgery (excluding biopsy) or significant trauma within 4 weeks before the first dose, or requires elective surgery during the trial period.
- Used strong inhibitors or inducers of CYP3A4, CYP1A2, and/or CYP2D6 within 14 days or 5 half-lives (whichever is shorter) before the first dose.
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- Previous allogeneic hematopoietic stem cell or bone marrow transplantation, or previous solid organ transplantation, or current use of immunosuppressive drugs or anti-rejection medications.
- Allergy to any active or inactive ingredient of the study drug.
- Adverse effects from prior anti-tumor treatments have not resolved to ≤Grade 1 according to CTCAE v5.0 (except for toxicities deemed not to pose a safety risk by the investigator, such as alopecia, Grade 2 peripheral neuropathy, or stable hypothyroidism managed with hormone replacement).
- Active hepatitis B (HBsAg positive with HBV-DNA > lower limit of detection at the study center); hepatitis C virus infection (HCV-RNA > lower limit of detection at the study center); positive HIV antibody test; positive Treponema pallidum antibody test.
- Presence of brain metastases or leptomeningeal metastases during the screening period or previously.
- Presence of uncontrolled third-space effusions (e.g., large pleural effusions and/or ascites) as judged by the investigator.
- Severe cardiovascular diseases, including but not limited to:
- Serious cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, II-III degree atrioventricular block, etc.
- Acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other Grade 3 or higher cardiovascular events within 6 months before the first dose.
- New York Heart Association (NYHA) functional class ≥II, or other high-risk structural heart diseases as judged by the investigator.
- Uncontrolled hypertension clinically (systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg after treatment).
- Any factors increasing the risk of QTc prolongation or arrhythmias, such as heart failure, uncorrectable hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or use of any concomitant drugs known to prolong the QT interval.
- Presence of active infections requiring systemic treatment within 4 weeks before the first dose.
- Presence of gastrointestinal diseases affecting drug absorption, such as Crohn's disease, ulcerative colitis, or short bowel syndrome, in an acute exacerbation phase, which may affect the absorption, metabolism, or elimination of the study drug as judged by the investigator.
- Presence of interstitial lung disease, pulmonary fibrosis, or drug-induced interstitial pneumonia, except for radiation-induced pneumonia.
- Presence of other severe diseases, including liver disease, kidney disease, neurological/psychiatric disorders, endocrine system diseases, hematologic diseases, immune system diseases, etc., that may affect participation in the study as judged by the investigator.
- Presence of other malignancies within the past 5 years, except for cured basal cell carcinoma of the skin, non-melanoma skin cancer, or in situ cervical cancer.
- Known alcohol or drug dependence.
- Presence of psychiatric disorders or poor compliance.
- Pregnant or breastfeeding women.
- Any other clinical or laboratory abnormalities or other reasons deemed by the investigator to make the subject unsuitable for participation in the study.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
The Fisrt Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui, 233004
Yuzhi Li, +86-13955256571
- Recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410013
Yongchang Zhang, +86-13873123436
About this study
Official title: Phase Ib/IIa Multicenter, Open-Label Study to Evaluate the Efficacy, Safety, and Pharmacokinetic Profile of DC05F01 in Patients With Recurrent/Refractory Ovarian Cancer and Other Advanced Solid Tumors
This study is a multicenter, open-label, cohort expansion Phase Ib/IIa trial designed to evaluate the efficacy, safety, and pharmacokinetic (PK) profile of DC05F01 in patients with recurrent/refractory ovarian cancer and other advanced solid tumors.
Read the detailed description
The study consists of two parts. Part A will expand the Phase I study based on safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy data to select the recommended Phase II dose (RP2D, tentatively set at 2100 mg). The study plans to enroll 10 patients with recurrent/refractory ovarian cancer into Cohort 1, 10 patients with limited-stage small cell lung cancer who have not progressed after chemoradiotherapy into Cohort 2, and 20 patients with other advanced malignant solid tumors into Cohort 3. All patients will receive oral DC05F01 once daily, continuously, with a 4-week treatment cycle to assess the efficacy, safety, and pharmacokinetic profile of DC05F01.
Part B will be determined based on the efficacy and safety data from Part A, with the investigator and sponsor jointly deciding on the appropriate indications for further expansion. It plans to enroll 20 patients to further evaluate the efficacy and safety of DC05F01.
- Conditions
- Solid Tumors, Ovarian Cancer, Small Cell Lung Cancer
- Being tested
- DC05F01
- Medical subject headings
- Ovarian Neoplasms, Small Cell Lung Carcinoma
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 |
|---|---|---|
| Part A Cohort1 | Experimental | Patients with recurrent/refractory ovarian cancer will receive oral 2100 mg DC05F01 once daily, continuously, with a 4-week treatment cycle Receives: Drug: DC05F01 |
| Part A Cohort2 | Experimental | Patients with limited-stage small cell lung cancer will receive oral 2100 mg DC05F01 once daily, continuously, with a 4-week treatment cycle Receives: Drug: DC05F01 |
| Part A Cohort3 | Experimental | Patients with other advanced malignant solid tumors will receive oral 2100 mg DC05F01 once daily, continuously, with a 4-week treatment cycle Receives: Drug: DC05F01 |
| Part B | Experimental | Patients with specific advanced malignant solid tumors will receive oral 2100 mg DC05F01 once daily, continuously, with a 4-week treatment cycle Receives: Drug: DC05F01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate (ORR)
Overall response rate (ORR) based on RECIST v1.1 as assessed by the investigator
Measured: Up to 24 months
Progression-free Survival (PFS)
Progression-free survival (PFS) based on RECIST v1.1 as assessed by the investigator
Measured: Up to 24 months
Secondary outcomes (6)
Number of Participants With Adverse Events
Incidence and severity of adverse events as assessed by CTCAE Version 5.0
Measured: 24 months
PK profile of DC05F01
Peak Concentration (Cmax): The maximum plasma concentration of the drug.
Measured: From time zero up to 24 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 24 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 24 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 24 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 24 hours post-dose
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 start11 Sep 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heronova Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06873555
- Sponsor's protocol ID
- SHRC-DC05F01-02
- Status last verified
- Sep 2026
- First submitted
- 7 Mar 2025
- Last updated
- 16 Sep 2026
- Results posted
- 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 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib/IIa Multicenter, Open-Label Study to Evaluate the Efficacy, Safety, and Pharmacokinetic Profile of DC05F01 in Patients With Recurrent/Refractory Ovarian Cancer and Other Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06873555
- Acronym / sponsor ID
- SHRC-DC05F01-02
- Conditions
- Solid Tumors, Ovarian Cancer, Small Cell Lung Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Heronova PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 11 Sep 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- 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 study is a multicenter, open-label, cohort expansion Phase Ib/IIa trial designed to evaluate the efficacy, safety, and pharmacokinetic (PK) profile of DC05F01 in patients with recurrent/refractory ovarian cancer and other advanced solid tumors.
Detailed description
The study consists of two parts. Part A will expand the Phase I study based on safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy data to select the recommended Phase II dose (RP2D, tentatively set at 2100 mg). The study plans to enroll 10 patients with recurrent/refractory ovarian cancer into Cohort 1, 10 patients with limited-stage small cell lung cancer who have not progressed after chemoradiotherapy into Cohort 2, and 20 patients with other advanced malignant solid tumors into Cohort 3. All patients will receive oral DC05F01 once daily, continuously, with a 4-week treatment cycle to assess the efficacy, safety, and pharmacokinetic profile of DC05F01.
Part B will be determined based on the efficacy and safety data from Part A, with the investigator and sponsor jointly deciding on the appropriate indications for further expansion. It plans to enroll 20 patients to further evaluate the efficacy and safety of DC05F01.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part A Cohort1 | Experimental | Drug: DC05F01Patients with recurrent/refractory ovarian cancer will receive oral 2100 mg DC05F01 once daily, continuously, with a 4-week treatment cycle |
| Part A Cohort2 | Experimental | Drug: DC05F01Patients with limited-stage small cell lung cancer will receive oral 2100 mg DC05F01 once daily, continuously, with a 4-week treatment cycle |
| Part A Cohort3 | Experimental | Drug: DC05F01Patients with other advanced malignant solid tumors will receive oral 2100 mg DC05F01 once daily, continuously, with a 4-week treatment cycle |
| Part B | Experimental | Drug: DC05F01Patients with specific advanced malignant solid tumors will receive oral 2100 mg DC05F01 once daily, continuously, with a 4-week treatment cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Voluntarily signed the informed consent form, understanding the study and willing to follow and capable of completing all trial procedures.
- Aged ≥18 years, regardless of gender.
- Patients with locally advanced or metastatic disease, including:
- Cohort 1: Epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer with FIGO stage III-IV, previously treated with platinum-based therapy and experienced disease progression or recurrence during or within 6 months (184 calendar days) after the last platinum-based treatment.
- Cohort 2: Limited-stage small cell lung cancer patients, as staged by the Veterans Administration Lung Study Group (VALG), who are not surgical candidates and have not progressed during or after at least 4 cycles of platinum-based chemotherapy combined with concurrent or sequential radiotherapy, completed within 6 weeks before the first dose.
Key exclusion criteria (27 listed)
- Received chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy, or other anti-tumor treatments within 4 weeks or 5 half-lives (whichever is shorter) before the first dose of the study drug, except for:
- Nitrosoureas or mitomycin C within 6 weeks before the first dose. Oral fluorouracil or small-molecule targeted drugs within 2 weeks or 5 half-lives (whichever is shorter) before the first dose.
- Anti-tumor traditional Chinese medicine within 2 weeks before the first dose.
- Received any other investigational drug or treatment in another clinical trial within 4 weeks before the first dose.
- Underwent major organ surgery (excluding biopsy) or significant trauma within 4 weeks before the first dose, or requires elective surgery during the trial period.
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 | Part A Cohort1, Part A Cohort2, Part A Cohort3, Part B |
Primary outcome
Overall response rate (ORR)
Time frame: Up to 24 months
Overall response rate (ORR) based on RECIST v1.1 as assessed by the investigator
Progression-free Survival (PFS)
Time frame: Up to 24 months
Progression-free survival (PFS) based on RECIST v1.1 as assessed by the investigator
6 secondary outcomes
Number of Participants With Adverse Events
Time frame: 24 months
PK profile of DC05F01
Time frame: From time zero up to 24 hours post-dose
PK profile of DC05F01
Time frame: From time zero up to 24 hours post-dose
PK profile of DC05F01
Time frame: From time zero up to 24 hours post-dose
PK profile of DC05F01
Time frame: From time zero up to 24 hours post-dose
PK profile of DC05F01
Time frame: From time zero up to 24 hours post-dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing DC05F01 in people with Solid Tumors and Ovarian Cancer, 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 15 inclusion and 27 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: looking for participants now, as of the sponsor's last update on 16 Sep 2026. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kang Ren (+86-13269683867, renkang@dcpc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (ORR) (time frame: Up to 24 months). The study lists 2 primary outcomes in all. 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 16 Sep 2026.