Solid Tumor CancerPhase 1NCT07583914
Safety, Tolerability, and Preliminary Antitumor Activity of Non-Cationic Peptide-CD47 siRNA in Advanced Solid Tumors
A Phase 1 study testing NCP-CD47 siRNA intratumorally injection in people with Solid Tumor Cancer and Metastases, run by West China Hospital.
Trial summary
This study evaluates a non-cationic peptide-CD47 siRNA nanocomplex for refractory advanced solid tumors. The candidate blocks the CD47-SIRPα "don't eat me" signal, repolarizes tumor-associated macrophages, and restores antitumor immunity. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Solid Tumor Cancer, Metastases, Head and Neck Cancer
- What is being tested?
- NCP-CD47 siRNA intratumorally injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- No sites listed yet
- Study dates
- 30 May 2026to 30 Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients aged ≥18 years and ≤70 years.
- Histopathologically confirmed advanced recurrent/metastatic malignant solid tumors that are refractory to second-line treatment and have no available standard clinical therapeutic options (e.g., advanced soft tissue sarcoma, advanced head and neck squamous cell carcinoma, malignant melanoma, etc.).
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
- Expected overall survival ≥3 months.
- Interval from the last chemotherapy, radiotherapy, or surgery ≥28 days.
- Interval from the last use of nitrosourea or mitomycin C ≥6 weeks.
Show all 15Show fewer
- Adequate organ function, defined by the following laboratory parameters within 14 days prior to enrollment:
- Hemoglobin ≥90 g/L (no blood transfusion within 14 days).
- Absolute neutrophil count >1.5 × 10⁹/L.
- Platelet count ≥80 × 10⁹/L.
- Total bilirubin ≤1.5 × upper limit of normal (ULN).
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤2.5 × ULN (≤5 × ULN in case of liver metastasis).
- Creatinine clearance ≥60 mL/min (calculated by Cockcroft-Gault formula).
- Left ventricular ejection fraction (LVEF) ≥50%.
- Signed written informed consent.
Who cannot join
- Participation in another investigational drug clinical trial within 4 weeks.
- Tumor located adjacent to major blood vessels or trachea.
- Uncontrolled cardiac clinical symptoms or diseases, including New York Heart -Association (NYHA) Class ≥2 heart failure, unstable angina, myocardial infarction within 1 year, or clinically significant supraventricular/ventricular arrhythmias requiring treatment or intervention.
- Female patients who are pregnant or lactating.
- Active pulmonary tuberculosis, bacterial or fungal infection (≥Grade 2 per NCI-CTCAE version 5.0), active human immunodeficiency virus (HIV) infection, active hepatitis B virus (HBV) infection, or hepatitis C virus (HCV) infection.
- History of uncontrollable psychoactive substance abuse or presence of mental disorders.
Show all 12Show fewer
- Any active autoimmune disease or history of autoimmune disease, including but not limited to uveitis, enteritis, hypophysitis, nephritis, hyperthyroidism, and hypothyroidism. Subjects with vitiligo or childhood asthma in complete remission (no adult intervention required) are eligible; subjects with asthma requiring bronchodilator therapy are excluded.
- Receiving immunosuppressive therapy.
- History of drug abuse or known medical, psychological, or social conditions that interfere with study compliance (e.g., alcoholism or illicit drug addiction).
- Known hypersensitivity, allergy, or intolerance to the study drug NCP-CD47 siRNA (including any excipients), or history of severe allergic reactions to any drugs, foods, or vaccines (e.g., anaphylactic shock, allergic laryngeal edema, allergic dyspnea, allergic purpura, thrombocytopenic purpura, local Arthus reaction, etc.).
- Female subjects planning pregnancy, or male subjects whose partner plans pregnancy, from screening until 12 months after the last study drug injection.
- Any concomitant disease that, in the investigator's judgment, may seriously compromise patient safety or prevent the subject from completing the study.
About this study
Official title: A Clinical Trial of Non-cationic Peptide-CD47 siRNA for Safety, Tolerability, and Preliminary Antitumor Activity in Patients With Advanced Malignant Solid Tumors
This study evaluates a non-cationic peptide-CD47 siRNA nanocomplex for refractory advanced solid tumors. The candidate blocks the CD47-SIRPα "don't eat me" signal, repolarizes tumor-associated macrophages, and restores antitumor immunity. Using a 3+3 dose-escalation design (25, 50, 100 μg), the investigators aim to define the MTD and RP2D, providing a novel therapeutic approach and clinical evidence for siRNA drug development.
Read the detailed description
This is a single-arm, open-label, non-randomized, single-center, prospective phase 1 clinical study conducted to evaluate the safety, tolerability, and preliminary antitumor activity of intratumorally injected NCP-CD47 siRNA in participants with advanced solid tumors. The primary objective is to assess the safety and tolerability of the NCP-CD47 siRNA formulation, and the secondary objective is to evaluate its preliminary antitumor activity. Safety refers to the frequency and severity of adverse events induced by NCP-CD47 siRNA, mainly assessed by the incidence of dose-limiting toxicities (DLTs), adverse events graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, and routine laboratory examinations including hematological and biochemical indicators. Tolerability reflects participants' ability to tolerate adverse events related to the study drug, mainly assessed by the number of treatment discontinuations due to treatment-related adverse reactions, as well as changes in physiological and biochemical parameters, body weight, and adverse event reports (CTCAE 5.0). The primary endpoint is the incidence of DLTs and the number of treatment discontinuations due to treatment-related adverse reactions during the first treatment cycle of NCP-CD47 siRNA administration. The secondary endpoints include objective response rate (ORR), disease control rate (DCR), time to first complete response (CR) or partial response (PR), duration of response (DOR, defined as the interval from the first confirmed CR or PR to the first disease progression or death from any cause), duration of stable disease (SD, defined as the interval from the first confirmed SD to the first disease progression or death from any cause), progression-free survival (PFS, defined as the interval from the first administration of NCP-CD47 siRNA to the first disease progression or death from any cause), and overall survival (OS, defined as the interval from the first administration of NCP-CD47 siRNA to death from any cause). The study plans to enroll 3 to 18 participants with advanced solid tumors who have failed second-line chemotherapy, adopts a standard "3+3" dose-escalation design with three siRNA dose levels (25 μg, 50 μg, and 100 μg) and 3 participants enrolled in each dose cohort, administers the NCP-CD47 siRNA formulation via intratumoral injection, and ensures that the formulation is manufactured under GMP-compliant conditions, then aliquoted and reserved for clinical use in accordance with the clinical administration protocol.
- Conditions
- Solid Tumor Cancer, Metastases, Head and Neck Cancer
- Being tested
- NCP-CD47 siRNA intratumorally injection
- Keywords
- Solid Tumor, siRNA, Cancer metastasis, Progress-free survival, Overall survival
- Medical subject headings
- Neoplasm Metastasis, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NCP-CD47 siRNA intratumorally injectionBiological
NCP-CD47 siRNA will be administered via intratumoral injection. A total of 5 doses will be given, with subsequent doses administered once weekly after the first injection.
| Study group | Role | What they receive |
|---|---|---|
| Intratumoral NCP-CD47 siRNA injection group | Experimental | Not described Receives: Biological: NCP-CD47 siRNA intratumorally injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)
DLT is defined as any Treatment-Related Adverse Event (TRAE) or clinically significant laboratory abnormality occurring during the DLT observation period. TRAEs include events judged by the investigator to be "definitely," "probably," or "possibly" related to the study treatment. Severity will be graded according to NCI-CTCAE v5.0.
Measured: From the first dose to the end of treatment at 9 weeks
Number of participants with treatment discontinuation due to treatment-related adverse events during the first treatment cycle
Treatment-related adverse events (TRAEs) will be assessed and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Treatment discontinuation is defined as permanent cessation of NCP-CD47 siRNA administration due to investigator-determined TRAEs occurring during the first treatment cycle.
Measured: From the first dose to the end of treatment at 9 weeks
Secondary outcomes (3)
Objective Response
Number of participants achieving a Best Overall Response (BOR) of either Complete Response (CR) or Partial Response (PR) according to RECIST v1.1. Due to the small sample size, data will be reported as absolute counts.
Measured: Time Frame: Up to 6 months from the date of the first dose.
Progression-Free Survival
Progression-Free Survival (PFS) is defined as the time interval from the start of treatment until the first documented occurrence of disease progression (PD) according to RECIST v1.1, or death due to any cause, whichever occurs first.
Measured: Up to 6 months from the date of the first dose.
Overall Survival
OS is defined as the time interval from the start of treatment to death due to any cause. For participants who are still alive at the end of the study, data will be censored at the last known date of follow-up.
Measured: Up to 12 months from the date of the first dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start30 May 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor CancerStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xingchen Peng, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07583914
- Sponsor's protocol ID
- 2026-892
- Status last verified
- May 2026
- First submitted
- 30 Apr 2026
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial of Non-cationic Peptide-CD47 siRNA for Safety, Tolerability, and Preliminary Antitumor Activity in Patients With Advanced Malignant Solid Tumors
- ClinicalTrials.gov ID
- NCT07583914
- Acronym / sponsor ID
- 2026-892
- Conditions
- Solid Tumor Cancer, Metastases, Head and Neck Cancer
- Keywords
- Solid Tumor, siRNA, Cancer metastasis, Progress-free survival, Overall survival
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 30 May 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 13 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates a non-cationic peptide-CD47 siRNA nanocomplex for refractory advanced solid tumors. The candidate blocks the CD47-SIRPα "don't eat me" signal, repolarizes tumor-associated macrophages, and restores antitumor immunity. Using a 3+3 dose-escalation design (25, 50, 100 μg), the investigators aim to define the MTD and RP2D, providing a novel therapeutic approach and clinical evidence for siRNA drug development.
Detailed description
This is a single-arm, open-label, non-randomized, single-center, prospective phase 1 clinical study conducted to evaluate the safety, tolerability, and preliminary antitumor activity of intratumorally injected NCP-CD47 siRNA in participants with advanced solid tumors. The primary objective is to assess the safety and tolerability of the NCP-CD47 siRNA formulation, and the secondary objective is to evaluate its preliminary antitumor activity. Safety refers to the frequency and severity of adverse events induced by NCP-CD47 siRNA, mainly assessed by the incidence of dose-limiting toxicities (DLTs), adverse events graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, and routine laboratory examinations including hematological and biochemical indicators. Tolerability reflects participants' ability to tolerate adverse events related to the study drug, mainly assessed by the number of treatment discontinuations due to treatment-related adverse reactions, as well as changes in physiological and biochemical parameters, body weight, and adverse event reports (CTCAE 5.0). The primary endpoint is the incidence of DLTs and the number of treatment discontinuations due to treatment-related adverse reactions during the first treatment cycle of NCP-CD47 siRNA administration. The secondary endpoints include objective response rate (ORR), disease control rate (DCR), time to first complete response (CR) or partial response (PR), duration of response (DOR, defined as the interval from the first confirmed CR or PR to the first disease progression or death from any cause), duration of stable disease (SD, defined as the interval from the first confirmed SD to the first disease progression or death from any cause), progression-free survival (PFS, defined as the interval from the first administration of NCP-CD47 siRNA to the first disease progression or death from any cause), and overall survival (OS, defined as the interval from the first administration of NCP-CD47 siRNA to death from any cause). The study plans to enroll 3 to 18 participants with advanced solid tumors who have failed second-line chemotherapy, adopts a standard "3+3" dose-escalation design with three siRNA dose levels (25 μg, 50 μg, and 100 μg) and 3 participants enrolled in each dose cohort, administers the NCP-CD47 siRNA formulation via intratumoral injection, and ensures that the formulation is manufactured under GMP-compliant conditions, then aliquoted and reserved for clinical use in accordance with the clinical administration protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intratumoral NCP-CD47 siRNA injection group | Experimental | Biological: NCP-CD47 siRNA intratumorally injection |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Male or female patients aged ≥18 years and ≤70 years.
- Histopathologically confirmed advanced recurrent/metastatic malignant solid tumors that are refractory to second-line treatment and have no available standard clinical therapeutic options (e.g., advanced soft tissue sarcoma, advanced head and neck squamous cell carcinoma, malignant melanoma, etc.).
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
- Expected overall survival ≥3 months.
- Interval from the last chemotherapy, radiotherapy, or surgery ≥28 days.
Key exclusion criteria (12 listed)
- Participation in another investigational drug clinical trial within 4 weeks.
- Tumor located adjacent to major blood vessels or trachea.
- Uncontrolled cardiac clinical symptoms or diseases, including New York Heart -Association (NYHA) Class ≥2 heart failure, unstable angina, myocardial infarction within 1 year, or clinically significant supraventricular/ventricular arrhythmias requiring treatment or intervention.
- Female patients who are pregnant or lactating.
- Active pulmonary tuberculosis, bacterial or fungal infection (≥Grade 2 per NCI-CTCAE version 5.0), active human immunodeficiency virus (HIV) infection, active hepatitis B virus (HBV) infection, or hepatitis C virus (HCV) infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NCP-CD47 siRNA intratumorally injectionNCP-CD47 siRNA will be administered via intratumoral injection. A total of 5 doses will be given, with subsequent doses administered once weekly after the first injection. | Biological | Intratumoral NCP-CD47 siRNA injection group |
Primary outcome
Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)
Time frame: From the first dose to the end of treatment at 9 weeks
DLT is defined as any Treatment-Related Adverse Event (TRAE) or clinically significant laboratory abnormality occurring during the DLT observation period. TRAEs include events judged by the investigator to be "definitely," "probably," or "possibly" related to the study treatment. Severity will be graded according to NCI-CTCAE v5.0.
Number of participants with treatment discontinuation due to treatment-related adverse events during the first treatment cycle
Time frame: From the first dose to the end of treatment at 9 weeks
Treatment-related adverse events (TRAEs) will be assessed and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Treatment discontinuation is defined as permanent cessation of NCP-CD47 siRNA administration due to investigator-determined TRAEs occurring during the first treatment cycle.
3 secondary outcomes
Objective Response
Time frame: Time Frame: Up to 6 months from the date of the first dose.
Progression-Free Survival
Time frame: Up to 6 months from the date of the first dose.
Overall Survival
Time frame: Up to 12 months from the date of the first dose.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
Related trials for Solid Tumor Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NCP-CD47 siRNA intratumorally injection in people with Solid Tumor Cancer and Metastases, run by West China Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) (time frame: From the first dose to the end of treatment at 9 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.