Actively Recruiting
Phase Ib/IIa Multicenter, Open-Label Study Evaluating DC05F01 for Recurrent/Refractory Ovarian Cancer and Other Advanced Solid Tumors
Led by Heronova Pharmaceuticals · Updated on 2025-03-19
60
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating DC05F01, an oral drug, in patients with recurrent or refractory ovarian cancer, limited-stage small cell lung cancer, and other advanced solid tumors. This multicenter, open-label Phase Ib/IIa trial aims to assess the drug's effectiveness, safety, and how it behaves in the body. The study is sponsored by Heronova Pharmaceuticals and focuses on patients who have already undergone standard treatments or have limited options. The trial has two parts. Part A enrolls patients into three cohorts based on their cancer type: ovarian cancer, small cell lung cancer, and other solid tumors. All participants receive 2100 mg of DC05F01 orally once daily in continuous 4-week cycles. Part B will expand based on Part A results, enrolling more patients to further evaluate safety and efficacy. Treatment continues with close monitoring throughout the study. Participants will undergo regular assessments including imaging to measure tumor response and blood tests to monitor safety and drug levels. The main outcomes measured are overall response rate and progression-free survival up to 24 months. Safety evaluations track adverse events, and pharmacokinetic studies measure how the drug is processed in the body. The study started in September 2024 and plans to continue until August 2026.
CONDITIONS
Brief Title
A Study of DC05F01 in Chinese Patients with Recurrent/Refractory Ovarian Cancer and Other Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and willing to complete all trial procedures
- Aged 18 years or older
- Diagnosed with locally advanced or metastatic epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer with progression after platinum therapy (Cohort 1), limited-stage small cell lung cancer without progression after chemoradiotherapy (Cohort 2), or other advanced solid tumors with no standard treatment options (Cohort 3)
- Underwent debulking surgery if in Cohort 1
- At least one measurable lesion according to RECIST 1.1 criteria for Cohorts 1 and 3
- ECOG performance status score of 0 or 1
- Expected survival of at least 3 months
- Adequate blood, liver, kidney, coagulation, and electrolyte function based on lab tests
- Agreement to use effective contraception for men and women of childbearing potential from consent until 3 months after last dose
- Negative pregnancy test for women of childbearing potential prior to first dose
You will not qualify if you...
- Receipt of chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy, or other anti-tumor treatments within 4 weeks or 5 half-lives before first dose, with some exceptions
- Participation in another clinical trial with investigational drugs within 4 weeks before first dose
- Major surgery or significant trauma within 4 weeks before first dose or scheduled surgery during trial
- Use of strong CYP3A4, CYP1A2, or CYP2D6 inhibitors or inducers within 14 days before first dose
- Previous allogeneic stem cell or organ transplant or current immunosuppressive therapy
- Allergy to study drug ingredients
- Unresolved adverse effects from prior anti-tumor treatments above Grade 1 except specified exceptions
- Active hepatitis B, hepatitis C, HIV, or syphilis infection
- Brain or leptomeningeal metastases
- Uncontrolled fluid buildup such as large pleural effusions or ascites
- Severe cardiovascular diseases including serious arrhythmias, recent major cardiovascular events, high-risk heart disease, or uncontrolled hypertension
- Active infections requiring systemic treatment within 4 weeks before first dose
- Gastrointestinal diseases affecting drug absorption in acute phase
- Interstitial lung disease, pulmonary fibrosis, or drug-induced interstitial pneumonia except radiation-induced pneumonia
- Other severe diseases affecting study participation
- Other malignancies within past 5 years except certain skin or cervical cancers
- Alcohol or drug dependence
- Psychiatric disorders or poor compliance
- Pregnant or breastfeeding women
- Any other clinical or lab abnormalities making participation unsuitable as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 24 months
Participants receive oral DC05F01 once daily continuously in 4-week treatment cycles to assess efficacy, safety, and pharmacokinetics.
Regular visits during treatment cycles
Trial Site Locations
Total: 2 locations
1
The Fisrt Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui, China, 233004
Actively Recruiting
2
Hunan Cancer Hospital
Changsha, Hunan, China, 410013
Actively Recruiting
Research Team
K
Kang Ren
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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