OncoMatch/Clinical Trials/NCT06307925
A Phase I Study to Evaluate the Safety, Pharmacokinetics and Antitumor Activity of HC010 in Patients With Advanced Solid Tumors
Is NCT06307925 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies HC010 for advanced solid tumor.
Treatment: HC010 — This clinical trial is a multicenter, open, single-arm, non-randomized, dose-escalation and dose-expansion, phase I clinical study in patients with advanced recurrent or metastatic solid tumors.The goal of this study is to evaluate the safety and tolerability of HC010 monotherapy in patients with advanced solid tumors.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Disease stage
Metastatic disease required
Participants with histologically or cytologically confirmed diagnosis of advanced solid tumors who have failed standard therapy or for whom no standard therapy is available. Participants must have at least one measurable lesion according to RECIST Version1.1
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: standard therapy
who have failed standard therapy or for whom no standard therapy is available
Cannot have received: interventional clinical trial treatment or other systemic chemotherapy, radiotherapy
Receipt of any interventional clinical trial treatment or other systemic chemotherapy, radiotherapy, etc. within 28 days or 5 half-lives (whichever is shorter) prior to the first dose of the HC010
Cannot have received: herbal or proprietary Chinese medicine with an anti-tumor indication
Receipt of herbal or proprietary Chinese medicine with an anti-tumor indication within 2 weeks prior to the first dose of HC010
Cannot have received: systemic glucocorticoids (prednisone >10 mg/day or equivalent)
Receipt of systemic glucocorticoids (prednisone >10 mg/day or equivalent doses of similar drugs) or other immunosuppressive agents within 2 weeks prior to the first dose of HC010
Cannot have received: immunomodulatory drugs
Receipt of immunomodulatory drugs within 2 weeks prior to the first dose of HC010
Cannot have received: live attenuated vaccination
Receipt of live attenuated vaccination within 4 weeks prior to the first dose of HC010
Cannot have received: anti-PD-1 therapy
Patients who have received biomolecule therapy for anti-programmed death receptor 1 (PD-1)
Cannot have received: anti-PD-L1 therapy
Patients who have received biomolecule therapy for ... programmed death ligand (PD-L1)
Cannot have received: anti-CTLA-4 therapy
Patients who have received biomolecule therapy for ... anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4)
Cannot have received: anti-VEGF therapy
Patients who have received biomolecule therapy for ... anti-vascular endothelial growth factor (VEGF) targets
Lab requirements
Blood counts
neutrophil count≥1.5×10^9/L, platelet count ≥100×10^9/L, hemoglobin≥90g/L
Kidney function
renal function ... basically normal
Liver function
alanine aminotransferase and aspartate aminotransferase ≤2.5×ULN; patients with hepatocellular carcinoma or concomitant hepatic metastases ≤5.0×ULN, total bilirubin ≤1.5×ULN
Cardiac function
cardiopulmonary function are basically normal
Adequate organ function: neutrophil count≥1.5×10^9/L,platelet count ≥100×10^9/L,hemoglobin≥90g/L,alanine aminotransferase and aspartate aminotransferase ≤2.5×upper limit of normal (ULN); patients with hepatocellular carcinoma or concomitant hepatic metastases ≤5.0×ULN, total bilirubin ≤1.5×ULN, renal function and cardiopulmonary function are basically normal.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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