Can a pill shrink Hard-to-Treat ovarian tumors?
NCT ID NCT06873555
First seen Sep 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time
Summary
Researchers are testing a new oral drug called DC05F01 in adults with recurrent ovarian cancer and other advanced solid tumors that have worsened after standard treatment. The trial aims to see how well the drug shrinks tumors, how long it keeps cancer from growing, and what side effects it causes. About 60 people will take DC05F01 capsules, and doctors will track their response and measure drug levels in the blood.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- DC05F01, an experimental oral drug
- What this could lead to
- If DC05F01 works, it could offer a new oral option for people with recurrent ovarian cancer or other advanced solid tumors that have stopped responding to standard treatments.
- What could go wrong
- This is an early-stage trial with about 60 participants, so researchers do not yet know if DC05F01 helps or causes serious side effects. Many experimental cancer drugs fail in early testing.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2024
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Voluntarily signed the informed consent form, understanding the study and willing to follow and capable of completing all trial procedures. 2. Aged ≥18 years, regardless of gender. 3. 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. 4. 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. 5. 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). 6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1. 7. Expected survival time of ≥3 months. 8. 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. 9. 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. Exclusion Criteria: 1. 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. 2. Received any other investigational drug or treatment in another clinical trial within 4 weeks before the first dose. 3. Underwent major organ surgery (excluding biopsy) or significant trauma within 4 weeks before the first dose, or requires elective surgery during the trial period. 4. 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. 5. Previous allogeneic hematopoietic stem cell or bone marrow transplantation, or previous solid organ transplantation, or current use of immunosuppressive drugs or anti-rejection medications. 6. Allergy to any active or inactive ingredient of the study drug. 7. 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). 8. 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. 9. Presence of brain metastases or leptomeningeal metastases during the screening period or previously. 10. Presence of uncontrolled third-space effusions (e.g., large pleural effusions and/or ascites) as judged by the investigator. 11. 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. 12. Presence of active infections requiring systemic treatment within 4 weeks before the first dose. 13. 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. 14. Presence of interstitial lung disease, pulmonary fibrosis, or drug-induced interstitial pneumonia, except for radiation-induced pneumonia. 15. 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. 16. 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. 17. Known alcohol or drug dependence. 18. Presence of psychiatric disorders or poor compliance. 19. Pregnant or breastfeeding women. 20. Any other clinical or laboratory abnormalities or other reasons deemed by the investigator to make the subject unsuitable for participation in the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Hunan Cancer Hospital
RECRUITINGChangsha, Hunan, 410013, China
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The Fisrt Affiliated Hospital of Bengbu Medical University
RECRUITINGBengbu, Anhui, 233004, China
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