OncoMatch/Clinical Trials/NCT07348211
First in Human Study of SIM0610 in Solid Tumors
Is NCT07348211 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including SIM0610 for and SIM0610 for for advanced solid tumours.
Treatment: SIM0610 for · SIM0610 for — This is a multicenter, open-label, first-in-human (FIH) study to evaluate the safety, tolerability, pharmacokinetic/pharmacodynamic profile, and preliminary antitumor activity of SIM0610 in subjects with locally advanced/metastatic solid tumors. Accelerated titration (ATD) and Bayesian optimal interval design (BOIN) will be used to guide dose escalation in part1, the preliminary anti-tumor effect of SIM0610 will to be further evaluated in part 2.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Colorectal Cancer
Head and Neck Squamous Cell Carcinoma
Hepatocellular Carcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: systemic anti-tumor regimen
experienced disease progression during/after at least one previous standard systemic anti-tumor regimen and are not suitable for standard treatment
Cannot have received: cytotoxic therapy
Cytotoxic therapy within 3 weeks
Cannot have received: anti-tumor targeted small-molecule drugs (tyrosine kinase inhibitors)
anti-tumor targeted small-molecule drugs (e.g., tyrosine kinase inhibitors) within 2 weeks
Cannot have received: immune checkpoint inhibitor
Anti-tumor antibody-based immune checkpoint inhibitors, antibody-drug conjugates (ADCs), or other anti-tumor biologics within the shorter of 5 half-lives or 4 weeks
Cannot have received: antibody-drug conjugate
antibody-drug conjugates (ADCs)
Cannot have received: antibody-drug conjugate (topoisomerase I inhibitor, EGFR, MET)
Received antibody-drug conjugate (ADC) with topoisomerase I inhibitor (TOP1i) or other ADC targeting EGFR/cMET
Cannot have received: radiation therapy
Radiotherapy within 4 weeks
Cannot have received: traditional Chinese medicine
Traditional Chinese medicines (TCMs)/herbal preparations with anti-tumor indications within 2 weeks
Lab requirements
Blood counts
Adequate organ and bone marrow function
Kidney function
Adequate organ and bone marrow function
Liver function
Adequate organ and bone marrow function
Adequate organ and bone marrow function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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