A Study of DC05F01 in Chinese Patients With Recurrent/Refractory Ovarian Cancer and Other Advanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHeronova Pharmaceuticals
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
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.
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).
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
DC05F01
DrugDC05F01 capsule
Treatment groups
60 Participants
are divided into 4 treatment groupsGroup A: Part A Cohort1Experimental treatment 1 intervention
Group B: Part A Cohort2Experimental treatment 1 intervention
Group C: Part A Cohort3Experimental treatment 1 intervention
Group D: Part BExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Overall response rate (ORR)
Overall response rate (ORR) based on RECIST v1.1 as assessed by the investigator
Time frame
Up to 24 months2
Progression-free Survival (PFS)
Progression-free survival (PFS) based on RECIST v1.1 as assessed by the investigator
Time frame
Up to 24 monthsSecondary outcomes
1
Number of Participants With Adverse Events
Incidence and severity of adverse events as assessed by CTCAE Version 5.0
Time frame
24 months2
PK profile of DC05F01
Peak Concentration (Cmax): The maximum plasma concentration of the drug.
Time frame
From time zero up to 24 hours post-dose3
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.
Time frame
From time zero up to 24 hours post-dose4
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.
Time frame
From time zero up to 24 hours post-doseSponsors and contacts
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Source ClinicalTrials.gov