Actively Recruiting
Safety and Pharmacokinetics of NM6603 in Chinese Patients With Advanced Solid Tumors
Led by NucMito Pharmaceuticals Co. Ltd. · Updated on 2026-01-14
30
Participants Needed
3
Research Sites
45 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is to assess the MTD and PK of NM6603 in adult patients with advanced solid tumors.
CONDITIONS
Official Title
Safety and Pharmacokinetics of NM6603 in Chinese Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years
- Diagnosis of advanced solid tumors, mainly advanced colorectal cancer or triple-negative breast cancer, confirmed by histology or cytology
- Prior standard therapy with documented progression, intolerance, or no available options
- At least one measurable tumor lesion according to RECIST version 1.1
- Body weight of 45 kg or greater for men and 40 kg or greater for women
- ECOG performance status of 0 or 1
- Expected survival time longer than 12 weeks
- Adequate organ and bone marrow function including neutrophil count ≥1500/mm3, platelet count ≥100000/mm3 without recent transfusions or growth factors, hemoglobin ≥9.0 g/dL without recent transfusions or stimulating factors
- Total bilirubin ≤1.5 times upper limit of normal (patients with Gilbert syndrome allowed)
- AST and ALT ≤2.5 times upper limit of normal without liver metastasis, or ≤5 times with liver metastasis
- Creatinine clearance ≥60 mL/min (Cockcroft-Gault formula)
- INR ≤1.5 times upper limit of normal and APTT ≤1.5 times upper limit of normal
- Agreement to use effective contraception from consent until 6 months after last dose (for males and females of childbearing potential)
- Negative pregnancy test within 7 days prior to first dose (for females of childbearing potential)
- Able and willing to comply with study visits and provide informed consent
You will not qualify if you...
- Known allergy or hypersensitivity to NM6603 or its components
- Prior treatment with drugs targeting the same mechanism or molecular target as NM6603
- Participation in another drug or device clinical trial within 4 weeks before first dose
- Major surgery within 4 weeks before first dose or planned surgery during the study
- Chemotherapy, biologic therapy, macromolecular targeted therapy, or radiotherapy within 4 weeks before first dose
- Use of oral fluoropyrimidines or other small molecule targeted agents within 2 weeks or 5 half-lives before first dose
- Use of traditional Chinese medicine or herbal products with antitumor activity within 2 weeks before first dose
- Use of medications that prolong QT interval or strong CYP1A2, CYP2A6, or CYP3A4 inhibitors/inducers within 7 days before first dose or need for continued use
- Systemic corticosteroids or immunosuppressive drugs above 10 mg/day prednisone equivalent within 4 weeks before first dose (except physiologic replacement or topical/inhaled forms)
- History of other malignancies within 5 years except certain treated cancers
- Active central nervous system metastases or unstable brain metastases
- Untreated asymptomatic brain metastases larger than 1.5 cm
- Uncontrolled active infections or serious cardiovascular/cerebrovascular events within 6 months
- Left ventricular ejection fraction below 50%, uncontrolled hypertension, uncontrolled hyperglycemia, certain arrhythmias, congenital long QT syndrome, QTcF over 450 ms
- Active peptic ulcer, gastritis, bleeding disorders
- Risk factors for pancreatitis (history, uncontrolled hyperlipidemia, excessive alcohol, uncontrolled diabetes, gallbladder disease, certain medications)
- Psychiatric or social conditions affecting compliance or consent
- Family history of long QT syndrome or sudden unexplained death before age 40 in first-degree relatives
- Inability to swallow oral medication or gastrointestinal conditions that impair drug absorption
- Known alcohol or substance dependence
- Active infections including syphilis, HIV, hepatitis B or C with active viral replication
- Not recovered to grade 1 or less from prior therapy toxicity except alopecia, grade 1 fatigue, or minor lab abnormalities
- Pregnant or breastfeeding women or planning pregnancy during the study
- Any condition that may affect compliance or suitability as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China, 361001
Actively Recruiting
2
Sun Yat-sen University Cancer Center (SYSUCC)
Guangzhou, Guangdong, China, 510060
Actively Recruiting
3
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052
Actively Recruiting
Research Team
C
COO
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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