OncoMatch/Clinical Trials/NCT06873555
A Study of DC05F01 in Chinese Patients with Recurrent/Refractory Ovarian Cancer and Other Advanced Solid Tumors
Is NCT06873555 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies DC05F01 for solid tumors.
Treatment: DC05F01 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Ovarian Cancer
Small Cell Lung Cancer
Disease stage
Required: Stage III, IV (FIGO (for Cohort 1), VALG (for Cohort 2))
Metastatic disease required
Cohort 1: FIGO stage III-IV; Cohort 2: limited-stage (VALG); Cohort 3: advanced solid tumors
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: platinum-based chemotherapy — Cohort 1: prior platinum-based therapy; Cohort 2: at least 4 cycles platinum-based chemotherapy with concurrent or sequential radiotherapy
Cohort 1: 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: have not progressed during or after at least 4 cycles of platinum-based chemotherapy combined with concurrent or sequential radiotherapy
Cannot have received: chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy, or other anti-tumor treatments
Exception: unless completed >4 weeks or 5 half-lives before first dose (nitrosoureas/mitomycin C: 6 weeks; oral fluorouracil/small-molecule targeted drugs: 2 weeks or 5 half-lives; anti-tumor traditional Chinese medicine: 2 weeks)
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.
Cannot have received: investigational drug or treatment in another clinical trial
Received any other investigational drug or treatment in another clinical trial within 4 weeks before the first dose.
Lab requirements
Blood counts
ANC >1.5×10^9/L; HGB ≥90 g/L; PLT >100×10^9/L
Kidney function
Serum Creatinine ≤1.5×ULN or CrCl ≥60 mL/min
Liver function
Total Bilirubin ≤1.5 mg/dL; AST/ALT/ALP/GGT ≤2.5×ULN (or <5×ULN if liver metastases); Albumin ≥3 g/dL
Cardiac function
No significant cardiac function abnormalities; see exclusion for details
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: 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. AST/ALT/ALP/GGT ≤2.5×ULN (or <5×ULN if liver metastases). 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.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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