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New treatment option for Solid Tumors
Official title A Study of DC05F01 in Chinese Patients with Recurrent/Refractory Ovarian Cancer and Other Advanced Solid Tumors
ClinicalTrials.gov ID: NCT06873555
What this study is testing
What is DC05F01?
DC05F01 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for solid tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Cohort 1: Patients must have undergone initial or interval debulking surgery. Elevated CA125 alone without radiological or clinical evidence cannot...
- According to RECIST 1.1 criteria, there must be at least one measurable lesion assessed by imaging (lesions within previously irradiated areas or...
You likely can't join if
- Received chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy, or other anti-tumor treatments within 4 weeks or 5...
- 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...
- 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.
- Previous allogeneic hematopoietic stem cell or bone marrow transplantation, or previous solid organ transplantation, or current use of...
- Allergy to any active or inactive ingredient of the study drug.
See the full eligibility criteria
Who can 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...
- 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...
- 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...
- 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...
- Male people 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...
What rules you out
- 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...
- 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.
- 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...
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Bengbu, Anhui, China
- Changsha, Hunan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bengbu, Anhui, China; Changsha, Hunan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.