Actively Recruiting
A Study of DC05F01 in Chinese Patients with Recurrent/Refractory Ovarian Cancer and Other Advanced Solid Tumors
Led by Heronova Pharmaceuticals · Updated on 2025-03-19
60
Participants Needed
2
Research Sites
98 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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...
- Age 18 years or older, any gender
- Signed informed consent and willing to complete all study procedures
- Locally advanced or metastatic disease in one of the following groups: epithelial ovarian, fallopian tube, or primary peritoneal cancer (Stage III-IV) with progression after platinum-based therapy; limited-stage small cell lung cancer without progression after chemoradiotherapy; or other advanced solid tumors with no standard treatment options
- For ovarian cancer: must have had initial or interval debulking surgery; elevated CA125 alone without clinical or radiological evidence does not count as progression
- For small cell lung cancer: must have completed at least 4 cycles of platinum-based chemotherapy plus radiotherapy
- At least one measurable lesion by imaging for ovarian cancer and other solid tumors
- ECOG performance status of 0 or 1
- Expected survival of 3 months or more
- Adequate blood counts, liver, kidney, coagulation, and heart function as specified
- Agreement to use effective contraception during and for 3 months after the study if of childbearing potential and negative pregnancy test prior to first dose
You will not qualify if you...
- Received chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy, or other anti-tumor treatments within 4 weeks or 5 half-lives before first dose except specified exceptions
- Participation in another investigational drug trial within 4 weeks before first dose
- Major organ surgery or significant trauma within 4 weeks before first dose or planned surgery during study
- 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 use of immunosuppressants
- Allergy to any component of the study drug
- Unresolved adverse effects from prior anti-tumor treatments above Grade 1 except certain exceptions
- Active hepatitis B or C infection, positive HIV or syphilis tests
- Brain or leptomeningeal metastases
- Uncontrolled large pleural effusions or ascites
- Severe cardiovascular diseases including serious arrhythmias, recent acute coronary events, NYHA class II or higher heart failure, uncontrolled hypertension, or risk factors for QTc prolongation
- Active infections requiring systemic treatment within 4 weeks
- Acute exacerbations of gastrointestinal diseases affecting drug absorption
- Interstitial lung disease, pulmonary fibrosis, or drug-induced interstitial pneumonia (except radiation-induced)
- Other severe diseases affecting study participation
- Other malignancies within past 5 years except certain cured skin and cervical cancers
- Known alcohol or drug dependence
- Psychiatric disorders or poor compliance
- Pregnant or breastfeeding women
- Any other condition deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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