OncoMatch/Clinical Trials/NCT06046066
A Phase 1 Study of NM6603 in Advanced Solid Tumors
Is NCT06046066 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies NM6603 for cancers.
Treatment: NM6603 — This study is to assess the MTD and RP2D of NM6603 in adult patients with advanced solid tumors.
Check if I qualifyExtracted eligibility criteria
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: anti-tumor therapy
Exception: chemotherapy, hormone therapy, radiation therapy, or immunotherapy within 4 weeks or 4 half-lives (whichever is shorter or as agreed between the site PI and Medical Monitor) prior to starting the study drug
Have received anti-tumor therapies such as chemotherapy, hormone therapy, radiation therapy, or immunotherapy within 4 weeks or 4 half-lives (whichever is shorter or as agreed between the site PI and Medical Monitor) prior to starting the study drug
Cannot have received: systemic corticosteroids
Exception: excluding inhalers or topicals; for a duration ≥ 4 weeks at the daily dose equivalent to ≥7.5 mg of oral prednisone within the 12 weeks prior to starting study drug
Have received systemic corticosteroids (either oral or intravenous steroids, excluding inhalers or topicals) for a duration ≥ 4 weeks at the daily dose equivalent to ≥7.5 mg of oral prednisone within the 12 weeks prior to starting study drug
Cannot have received: investigational agent
Exception: within 28 days or four half-lives (whichever is shorter, or as agreed between the site PI and Medical Monitor) prior to first study drug administration
Are currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 28 days or four half-lives (whichever is shorter, or as agreed between the site PI and Medical Monitor) prior to first study drug administration
Lab requirements
Blood counts
Absolute neutrophil count ≥1.5×10^9 cell/L; Platelet count ≥100×10^9 cell/L; Hemoglobin at least ≥9.0 g/dL
Kidney function
glomerular filtration rate ≥60 mL/min (Cockcroft and Gault); No clinically relevant abnormalities in the urinalysis results
Liver function
Total serum bilirubin ≤ 1.5× ULN; ALT and AST ≤2.5× ULN or ≤5.0× ULN in case of documented hepatic metastasis; Alkaline phosphatase ≤ 5× ULN
Cardiac function
No abnormalities in the 12-lead ECG that in the opinion of the Investigator increase the risk of participating in the study (e.g., sinus rhythm with PR interval > 240 ms or second degree or higher AV block, confirmed by a repeat ECG); No ECG evidence of complete left bundle branch block or ventricular pacing; No history of long QT syndrome or prolonged QT interval corrected based on Fridericia's method (QTcF) >450 ms at screening; No unstable angina, myocardial infarction or cerebrovascular accident, transient ischemic attack, cardiac failure with known ejection fraction less than 40% within the 6-month period prior to screening
Have adequate bone marrow reserve: Absolute neutrophil count ≥1.5×10^9 cell/L; Platelet count ≥100×10^9 cell/L; Hemoglobin at least ≥9.0 g/dL. Have adequate liver function: Total serum bilirubin ≤ 1.5× ULN; ALT and AST ≤2.5× ULN or ≤5.0× ULN in case of documented hepatic metastasis; Alkaline phosphatase ≤ 5× ULN. Have adequate renal function: glomerular filtration rate ≥60 mL/min (Cockcroft and Gault); No clinically relevant abnormalities in the urinalysis results. Have abnormalities in the 12-lead ECG that in the opinion of the Investigator increase the risk of participating in the study (e.g., sinus rhythm with PR interval > 240 ms or second degree or higher AV block, confirmed by a repeat ECG); ECG evidence of complete left bundle branch block or ventricular pacing; history of long QT syndrome or prolonged QT interval corrected based on Fridericia's method (QTcF) >450 ms at screening; unstable angina, myocardial infarction or cerebrovascular accident, transient ischemic attack, cardiac failure with known ejection fraction less than 40% within the 6-month period prior to screening
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Karmanos Cancer Institute · Detroit, Michigan
- Cleveland Clinic Taussig Cancer Center · Cleveland, Ohio
- Tennessee Oncology, PLLC · Nashville, Tennessee
- MD Anderson Cancer Center · Houston, Texas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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