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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.

Phase 1RecruitingHC Biopharma Inc.NCT06307925Data as of May 2026

Treatment: HC010This 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.

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Extracted 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

Min 1 prior line

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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