Actively Recruiting
A Phase Ib/IIa Study Evaluating Safety, Tolerability, and Preliminary Efficacy of CNSI-Fe Intratumoral Injection in Advanced Solid Tumors
Led by Sichuan Enray Pharmaceutical Sciences Company · Updated on 2026-02-25
54
Participants Needed
9
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating CNSI-Fe, an innovative anti-cancer drug containing Fe2+ loaded on carbon nanoparticles, in people with advanced solid tumors. CNSI-Fe works by regulating a cell death process called ferroptosis and aims to improve cancer treatment through intratumoral injections. This Phase Ib/IIa study follows an initial Phase I trial where different doses showed promising safety and disease control in various advanced solid tumor patients. Participants will receive CNSI-Fe injections directly into 1 to 3 tumor lesions every two weeks for a total of 4 doses, with the possibility of additional doses if the benefits outweigh risks. The study includes a screening period, treatment period, and follow-up phase. Tumor response and safety will be closely monitored, and injections will stop or switch lesions based on tumor shrinkage or disappearance. During the study, participants will undergo safety checks before each dose and tumor evaluations at specified intervals, including before the third dose, after the fourth dose, and every six weeks thereafter. Follow-up includes safety monitoring 28 days after the last dose and regular checks for disease progression until new treatment, death, or study end. Samples will be collected at scheduled visits to assess safety, drug levels, and anti-tumor effects.
CONDITIONS
Brief Title
Carbon Nanoparticle-Loaded Iron in the Treatment of Advanced Solid Tumor
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understand and voluntarily sign informed consent
- Male or female aged 18 to 80 years
- Have advanced solid tumors confirmed by biopsy or cytology with no effective standard treatment or progression after standard therapy
- Have at least one measurable lesion not previously radiated or progressed after radiotherapy
- Have injectable lesions suitable for repeated intratumoral injection
- ECOG performance status 0 or 1 within 7 days before first dose
- Expected survival of at least 3 months
- Prior therapy adverse effects recovered to grade 1 or below
- Left ventricular ejection fraction of 50% or higher
- Adequate hematologic, kidney, liver, and coagulation function within 7 days before first dose
- Female participants of childbearing potential must have negative pregnancy test and use effective contraception or abstinence during and 6 months after treatment
- Male participants must use effective contraception or abstinence during and 6 months after treatment and agree not to donate sperm
You will not qualify if you...
- Diseases with abnormal iron metabolism except iron deficiency anemia
- Perforation signs at injection site
- Local skin breakdown or infection at injection site affecting treatment
- Systemic chemotherapy, targeted or biological therapy, immunotherapy within 3 weeks prior to first dose
- Radiotherapy within 14 days prior to first dose (except CNS radiotherapy needing 28-day washout)
- Major surgery within 4 weeks or unhealed wounds
- Untreated or active brain/spinal metastases unless stable and asymptomatic for at least 4 weeks
- Uncontrolled hypertension (SBP >160 mmHg or DBP >100 mmHg)
- Uncontrolled tumor-related pain
- Uncontrolled pleural, pericardial effusion, or ascites needing frequent drainage
- Active malignancy within 5 years except certain skin, prostate, breast, or cervical cancers
- Live virus vaccination within 4 weeks prior to first dose
- History of immunodeficiency or organ transplantation
- Active hepatitis B or C infection or positive HIV test
- Severe infection requiring systemic therapy
- Severe cardiac disease or recent events within 6 months
- Active psychiatric disorders
- Known allergy to study drug ingredients
- Participation in other interventional trials within 3 weeks
- Any condition judged unsuitable by investigator for study participation
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) for screening and enrollment
Duration - Approximately 8 weeks or longer if additional doses are given
Participants receive CNSI-Fe intratumoral injections once every two weeks for a total of 4 doses, with possible additional doses depending on investigator judgment. Safety checks occur within 7 days before each dose and two weeks after the last dose. Tumor efficacy is evaluated at specified time points during treatment.
Up to 4 dosing visits every 2 weeks plus safety and tumor evaluation visits around dosing
Duration - Variable, continuing until disease progression or other study endpoints
After treatment ends, participants enter a follow-up period including a safety follow-up 28 days after last dose and disease progression assessments every 6 weeks until progression, new therapy, death, withdrawal, or study end.
Safety follow-up 1 visit approximately 4 weeks after last dose; then disease progression assessments every 6 weeks
Trial Site Locations
Total: 9 locations
1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100005
Not Yet Recruiting
2
Hunan Provincial Tumor Hospital
Hunan, Changsha, China, 410000
Not Yet Recruiting
3
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 400042
Actively Recruiting
4
Fujian provincial cancer hospital
Fuzhou, Fujian, China, 350014
Not Yet Recruiting
5
Second Affiliated Hospital of Hainan Medical University
Haikou, Hainan, China, 571626
Actively Recruiting
6
Harbin medical university cancer hospital
Heilongjiang, Harbin, China, 150081
Not Yet Recruiting
7
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Not Yet Recruiting
8
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610041
Actively Recruiting
9
The First Affiliated Hospital of Zhengzhou University
Henan, Zhengzhou, China, 450052
Actively Recruiting
Research Team
X
Xiaohai Tang, PhD & MD
Y
Yan Chen, Bachelor's
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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