OncoMatch/Clinical Trials/NCT06761651
A Study of TAVO412 in Patients with Cancer (TAVO412)
Is NCT06761651 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Other
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.
Frequently asked questions
Is NCT06761651 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior chemotherapy, targeted small molecule therapy, radiotherapy disqualifies patients from enrollment.
Does this trial require EGFR?
Yes, EGFR mutation is a required biomarker for enrollment.
Does this trial require EGFR?
Yes, EGFR amplification is a required biomarker for enrollment.
Does this trial require EGFR?
Yes, EGFR overexpression is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify