OncoMatch/Clinical Trials/NCT06761651
A Study of TAVO412 in Patients with Cancer (TAVO412)
Is NCT06761651 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies TAVO412 for cancer.
Treatment: TAVO412 — TAVO412 Phase 1 is an open-label, non-randomized, 2-part Phase I study to examine the safety, tolerability, pharmacokinetics/pharmacodynamics, and preliminary efficacy of TAVO412. Part 1 will utilize a standard 3 + 3 design to determine the MTD/RP2D of TAVO412 in subjects with advanced or metastatic solid tumors who progressed on prior approved standard of care therapy. Part 2 will further evaluate the safety, tolerability, preliminary efficacy, pharmacokinetics (PK), and pharmacologic activity of TAVO412 in a new set of subjects with advanced or metastatic gastric cancer, non-small cell lung cancer (NSCLC), or subjects of other solid tumor types with best clinical responses (e.g., CR \> PR \> SD) from Part 1 that progressed on prior approved standard of care therapy.
Check if I qualifyExtracted eligibility criteria
Biomarker criteria
Required: EGFR mutation
mutations or gene amplification in EGFR
Required: EGFR amplification
mutations or gene amplification in EGFR
Required: EGFR overexpression (IHC ≥2+ (≥ intermediate/moderate staining))
EGFR overexpression (IHC≥2+ in reference central laboratory immunohistochemistry antibody interpretation criteria, ≥ moderate staining)
Required: MET mutation
mutations or gene amplification in MET
Required: MET amplification
mutations or gene amplification in MET
Required: MET overexpression (IHC ≥2+ (≥ intermediate/moderate staining))
cMET overexpression (IHC≥2+ in reference central laboratory immunohistochemistry antibody interpretation criteria, ≥ moderate staining)
Required: VEGFA mutation
mutations or gene amplification in VEGF
Required: VEGFA amplification
mutations or gene amplification in VEGF
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: standard therapy
have failed standard therapy or have no standard therapy
Cannot have received: chemotherapy
Exception: allowed if >14 days since last dose
Chemotherapy, targeted small molecule therapy, or radiotherapy ≤ 14 days
Cannot have received: targeted small molecule therapy
Exception: allowed if >14 days since last dose
Chemotherapy, targeted small molecule therapy, or radiotherapy ≤ 14 days
Cannot have received: radiotherapy
Exception: allowed if >14 days since last dose; 1 week washout after palliative radiotherapy for non-CNS disease allowed with sponsor approval
Chemotherapy, targeted small molecule therapy, or radiotherapy ≤ 14 days
Cannot have received: immunotherapy
Exception: allowed if >28 days since last dose
immunotherapy or cell therapy prior to 28 days
Cannot have received: cell therapy (CAR-T cell therapy)
Exception: allowed if >28 days since last dose
chimeric antigen receptor T cell therapy; Other cell therapies must be discussed with the investigator
Cannot have received: monoclonal antibody
Exception: allowed if >28 days since last dose (except denosumab)
Monoclonal antibodies used for anticancer therapy prior to 28 days, with the exception of denosumab
Cannot have received: Chinese medicine
Exception: allowed if >14 days since last dose
Chinese medicine used for anti-tumor before 14 days
Cannot have received: immunosuppressive therapy
Exception: allowed if >7 days since last dose
7 days for immunosuppressive therapy for any reason
Cannot have received: investigational drug
Exception: allowed if >28 days or >5 half-lives (whichever is longer) since last dose
All other investigational drugs or devices are ≤ 28 days or 5 half-lives (whichever is longer) prior to the first dose
Lab requirements
Blood counts
Absolute neutrophil count ≥1.5×10^9/L, platelet ≥100×10^9/L, hemoglobin ≥9 g/dL or ≥5.6 mmol/L, no transfusion or colony-stimulating factors
Kidney function
Creatinine clearance ≥30 mL/min (Cockcroft-Gault formula)
Liver function
AST and ALT ≤2.5×ULN (≤5×ULN for subjects with primary or metastatic liver cancer); total bilirubin ≤1.5×ULN (≤3×ULN for Gilbert's syndrome); direct bilirubin <40% of total if no ULN at institution
Cardiac function
QTcF <470ms (female) or <450ms (male); no recent MI, unstable angina, CVA, NYHA III/IV CHF, or significant arrhythmias
Absolute neutrophil count ≥ 1.5 ×109/L, platelet ≥ 100 ×109/L, hemoglobin ≥9 g/dL or ≥5.6 mmol/L, ... AST and ALT≤2.5×ULN (AST and ALT in subjects with primary or metastatic liver cancer≤5× ULN)。 ... Creatinine clearance ≥ 30 mL/min ... QTcF ≥470ms (Female) or≥450ms (Male) Or congenital long QT syndrome history or family history
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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