Actively Recruiting
Phase I Study to Evaluate Safety, Tolerability, and Pharmacokinetics of NM6603 in Adults With Advanced Solid Tumors
Led by NucMito Pharmaceuticals Co. Ltd. · Updated on 2026-01-14
30
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating NM6603, an investigational oral drug, in adults with advanced solid tumors including colorectal cancer and triple-negative breast cancer. This Phase 1, open-label, dose-escalation study aims to find the maximum tolerated dose (MTD), understand how the drug is processed in the body, and observe preliminary antitumor activity. The study focuses on patients who have progressed on or cannot receive standard treatments. Participants receive NM6603 orally every day in cycles of 28 days. The study uses a 3+3 design to gradually increase the dose and monitor safety. The treatment period includes dose escalation, followed by further evaluation of safety, tolerability, and pharmacokinetics, with ongoing assessment of antitumor effects. During the trial, participants will have tumor evaluations based on RECIST 1.1 criteria, and undergo safety tests including blood counts and organ function assessments. Researchers will measure drug concentrations and monitor for side effects over up to one year. The main outcomes include determining the recommended dose for future studies, drug safety, and overall survival, with participants followed through study visits and procedures throughout the treatment and observation periods.
CONDITIONS
Brief 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 at consent
- Diagnosed with advanced solid tumors, mainly colorectal or triple-negative breast cancer, confirmed by histology or cytology
- Prior standard therapy with documented progression, intolerance, or no available options
- At least one tumor lesion measurable by RECIST 1.1
- Body weight 45 kg or more for men, 40 kg or more for women
- ECOG performance status of 0 or 1
- Expected survival longer than 12 weeks
- Adequate organ and bone marrow function as defined by blood counts and liver, kidney tests
- Agree to use effective contraception from consent until 6 months after last dose
- Able and willing to comply with study procedures and provide informed consent
You will not qualify if you...
- Known allergy to NM6603 or its components
- Prior treatment targeting the same mechanism as NM6603
- Participation in another drug or device trial within 4 weeks before first dose
- Major surgery within 4 weeks before first dose or planned surgery during study
- Chemotherapy, biologic therapy, radiotherapy within 4 weeks before first dose
- 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 prolonging QT interval or strong CYP inhibitors/inducers within 7 days before first dose
- Systemic corticosteroids or immunosuppressives above 10 mg/day prednisone within 4 weeks before first dose
- History of another cancer within 5 years except certain treated cancers
- Active or unstable brain metastases; treated brain metastases must be stable for 4 weeks
- Uncontrolled infections, cardiovascular, or metabolic diseases
- Psychiatric or social conditions affecting compliance
- Family history of long QT syndrome or unexplained sudden death before age 40
- Inability to swallow oral medication or major gastrointestinal disease
- Alcohol or substance dependence
- Active infections including syphilis, HIV, hepatitis B or C
- Not recovered from prior therapy toxicity to grade 1 or less except alopecia, fatigue, or minor lab abnormalities
- Pregnant or breastfeeding or planning pregnancy during study
- Any condition making participation unsuitable or affecting compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive NM6603 orally every day in 28-day cycles to evaluate safety, tolerability, and pharmacokinetics.
Visits occur regularly during each 28-day cycle to monitor safety and collect pharmacokinetic data
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
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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