Advanced Solid TumorsPhase 1NCT07101549
Treating Nectin-4-positive Advanced Solid Tumors With R-Star001 (Nectin-4-CART-IL18)
A Phase 1 study testing R-Star001 in people with Advanced Solid Tumors, run by changjianhua at 1 site in China.
Trial summary
A single-center, single-arm, dose-escalation exploratory clinical trial on the safety, efficacy, and pharmacokinetics of R-Star001 cell injection in patients with Nectin-4-positive advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- R-Star001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2025to 1 Aug 2028
- 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
- Voluntarily participate in the clinical trial; fully understand and be informed about this study and sign the informed consent form; be willing to follow and be able to complete all trial procedures;
- At the time of screening, the age should be between 18 and 70 years old (inclusive), regardless of gender;
- Patients with pathologically diagnosed advanced solid tumors (including but not limited to breast cancer, urothelial cancer, colorectal cancer, head and neck squamous cell carcinoma, ovarian cancer, esophageal cancer, pancreatic cancer, non-small cell lung cancer (NSCLC)) who have failed standard treatment;
- The histological or cytological tumor specimens have been confirmed by immunohistochemistry to have high or moderate expression of Nectin-4;
- The patient has at least one measurable lesion (according to the requirements of RECIST version 1.1, the long diameter of the measurable lesion on spiral CT scan is ≥ 10mm or the short diameter of the enlarged lymph node is ≥ 15mm. See Annex 1 for RECIST version 1.1);
- At the time of enrollment, the expected survival time is more than 12 weeks;
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- At the time of screening, the laboratory tests should meet the following requirements:
- White blood cell count ≥ 3.0×10⁹/L;
- Neutrophil count ≥ 1.5×10⁹/L;
- Lymphocyte count ≥ 0.5×10⁹/L;
- Hemoglobin ≥ 90 g/L;
- Platelets ≥ 75×10⁹/L;
- Serum total bilirubin ≤ 2.0× the upper limit of normal value (ULN);
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5× ULN; For patients with liver metastases or those with primary liver tumor lesions, the aspartate transaminase and alanine transaminase should be ≤ 5×ULN. For patients with a history of Gilbert's syndrome/suspected of having the disease, the total bilirubin (TBIL) should be ≤ 3×ULN;
- Creatinine < 1.5×ULN and endogenous creatinine clearance rate ≥ 50 mL/minute (Cockcroft-Gault method for calculating creatinine clearance rate: For men, creatinine clearance rate = [(140 - age) × body weight (kg)] / [0.818 × creatinine (μmol/L)]; For women, creatinine clearance rate = [(140 - age) × body weight (kg) × 0.85] / [0.818 × creatinine (μmol/L)]).
- Good lung function, with a baseline fingertip pulse oximetry saturation ≥ 95% in an indoor air environment;
- The Eastern Cooperative Oncology Group (ECOG) performance status score is 0 or 1;
- Female subjects with reproductive potential must undergo a serum pregnancy test at the time of screening and before receiving pre-treatment, and the result must be negative. They should be willing to use a highly effective and reliable contraceptive method within 1 year after the last use of the test drug. Available methods include: bilateral tubal ligation/bilateral salpingectomy or bilateral fallopian tube occlusion; or approved oral, injectable or implanted hormonal contraceptive methods; or barrier contraceptive methods: condoms or occlusive caps (diaphragm or cervical/vaginal vault caps) containing spermicidal foam/gel/membrane/cream/suppository;
- For men who have an active sexual life with women of reproductive potential and have not had a vasectomy, they must agree to use a barrier method of contraception, such as a condom containing spermicidal foam/gel/membrane/cream/suppository, or their spouses should use a contraceptive method (see Inclusion Criteria item 10). Moreover, all men are absolutely prohibited from donating sperm within 1 year after receiving the last infusion of the test drug;
- A venous access can be established, and the collection of peripheral blood mononuclear cells can be carried out as judged by the investigator.
Who cannot join
- Pregnant or lactating women;
- Those with a history of allergy to immunotherapy, allergy to related drugs, a history of severe allergies in the past, and allergy to the components of R-Star001;
- Patients with other malignant tumors, except for the following situations: cured non-melanoma skin cancer, in-situ cervical cancer, localized prostate cancer, superficial bladder cancer, and other malignant tumors with a disease-free survival period of more than 3 years;
- Symptomatic intracranial or spinal cord metastasis of the tumor;
- Positive for hepatitis B surface antigen (HBsAg) positive, hepatitis B e-antigen (HBeAg) positive, hepatitis B e-antibody (HBeAb) positive, hepatitis B core antibody (HBcAb) positive, hepatitis C virus antibody (HCV-Ab) positive, anti-Treponema pallidum antibody (TP-Ab) ; subjects meeting any one of the above items;
- Any uncontrolled active infection, including but not limited to active tuberculosis and other bacterial, viral or fungal infections requiring drug treatment. Subjects who are using drugs to prevent infection can continue the trial as judged by the investigator;
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- Those who have received live vaccines or live attenuated vaccines within 4 weeks before apheresis;Have received the last dose of antitumor therapy (chemotherapy, endocrine therapy, immunotherapy, targeted therapy, tumor embolization, or Chinese herbal medicine with antitumor indications, etc.) within 3 weeks before leukocyte apheresis;
- The toxic and side effects caused by previous treatment have not recovered to CTCAE ≤ Grade 1;
- Those who have received any genetically engineered modified cell therapy in the past;
- Subjects at high risk of causing bleeding or perforation;
- Subjects who require anticoagulant therapy;
- Subjects who require long-term antiplatelet therapy;
- Subjects with a history of organ transplantation or those waiting for organ transplantation;
- Subjects who have undergone major surgery or suffered significant trauma within 4 weeks, or those who are expected to undergo major surgery during the study period;
- Those with other serious diseases that may limit the subject's participation in this trial;
- Subjects with signs of central nervous system diseases or clinically significant abnormal results of neurological examinations;
- Those with a history of abuse of psychotropic drugs who are unable to quit or those with a history of mental disorders;
- Subjects who, as evaluated by the investigator, are unable or unwilling to comply with the requirements of the study protocol;
- Situations in which the subject, as judged by the investigator, is not suitable for the trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Cancer Hospital Chinese Academy Of Medical Sciences,Shenzhen Center
Shenzhen, Guangdong, 518100
Jianhua Chang, 86-18038168872, changjianhua@163.com
About this study
Official title: A Single-center, Single-arm, Dose-escalation Exploratory Clinical Trial on the Safety, Efficacy, and Pharmacokinetics of R-Star001 Cell Injection in Patients With Nectin-4-positive Advanced Solid Tumors
A single-center, single-arm, dose-escalation exploratory clinical trial on the safety, efficacy, and pharmacokinetics of R-Star001 cell injection in patients with Nectin-4-positive advanced solid tumors.
Read the detailed description
This study is a prospective, single-center, single-arm, open-label, single-dose administration dose-finding study, which aims to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor efficacy characteristics of the R-Star001 cell injection in subjects with Nectin-4 positive advanced solid tumors.
The study will enroll subjects with pathologically confirmed advanced solid tumors (including, but not limited to breast cancer, urothelial carcinoma, colorectal cancer, head and neck squamous cell carcinoma, ovarian cancer, esophageal cancer, lung cancer) who have failed standard therapy; AND immunohistochemical analysis of histological or cytological tumor specimens demonstrates moderate to high Nectin-4 expression.
This prospective, single-center, single-arm, open-label study employs a single-dose administration design across two sequential stages. Stage 1 (Dose Escalation) utilizes an accelerated titration approach with standard '3+3' dose escalation to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of R-Star001 Cell Injection in subjects with Nectin-4 positive advanced solid tumors, thereby determining expansion dose levels based on integrated cohort data. Stage 2 (Dose Expansion) will enroll up to 9 subjects per cohort (including escalation-phase subjects) at 1-2 selected dose levels to further characterize safety and efficacy. The Recommended Phase II Dose (RP2D) will be determined post-infusion through comprehensive analysis of Stage 1 safety/efficacy outcomes, pharmacokinetic profiles, and prior preclinical/clinical evidence.
Main purpose:
the safety and tolerability of R-Star001 cell injection in patients with Nectin-4 positive advanced solid tumors, and determine the Recommended Phase II Dose (RP2D).
Secondary Purpose:
The pharmacokinetic and pharmacodynamic characteristics of R-Star001 cell injection in patients with Nectin-4 positive advanced solid tumors; To preliminarily evaluate the efficacy of R-Star001 cell injection in patients with Nectin-4 positive advanced solid tumors.
Evaluate the immunogenicity of R-Star001 cell injection.
- Conditions
- Advanced Solid Tumors
- Being tested
- R-Star001
- Keywords
- Nectin-4-positive advanced solid tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
R-Star001Drug
Drug: Nectin-4-targeted CAR T-cell injection with inducing IL-18 secretion (R-Star001).
The trial consists of a traditional '3 + 3' pattern dose-escalation phase and a dose-expansion phase.
| Study group | Role | What they receive |
|---|---|---|
| Nectin-4-targeted CAR T-cell injection with inducing IL-18 secretion | Experimental | Experimental: Phase 1, open-label, single-arm trial. Drug: Nectin-4-targeted CAR T-cell injection with inducing IL-18 secretion. Receives: Drug: R-Star001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicity (DLT)
Dose limiting toxicity (DLT) in the dose escalation phase
Measured: 28 days of single infusion
Adverse events (AEs)
The incidence rate of treatment-emergent adverse events (TEAEs), the incidence rate of treatment-related adverse events, and the incidence rate of adverse events of special interest (AESIs)
Measured: 1 year
Maximum tolerated dose (MTD)
Maximum tolerated dose (MTD) in the dose escalation phase
Measured: 28 days of single infusion
Secondary outcomes (8)
Objective response rate (ORR)
After treatment with R-Star001 cell infusion, the proportion of subjects whose tumors achieved complete response (CR) or partial response (PR). The objective response rate of tumors is only calculated for patients with measurable diseases according to the RECIST 1.1 criteria.
Measured: 1 year
Disease Control Rate (DCR)
After treatment with R-Star001 cell infusion, the proportion of subjects who achieved complete response, partial response, and stable disease.
Measured: 1 year
Progression - free survival (PFS)
The time from the date of starting the treatment with R-Star001 cell infusion to the date of the first radiological confirmation of disease progression (PD) or the date of death (due to any cause), whichever occurs first.
Measured: 1 year
Overall survival (OS)
The time from the date of starting the treatment with R-Star001 cell infusion to the date of death (caused by any reason).
Measured: 1 year
Immunogenicity
The incidence of antibodies against the R-Star001 cell injection and the titer of positive samples.
Measured: 1 year
Cellular pharmacokinetics (Cmax)
The peak concentration (Cmax)of CAR copy number in peripheral blood for R-Star001 cell injection.
Measured: 1 year
Cellular pharmacokinetics (Tmax)
Time to peak concentration (Tmax) of CAR copy number in peripheral blood for R-Star001 cell injection.
Measured: 1 year
Cellular pharmacokinetics (AUC)
Area under the plasma concentration-time curve (AUC) of R-Star001 cell injection in peripheral blood over 28/90 days.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start1 Aug 2025 (estimated)
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- changjianhua
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, changjianhua, Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center
- Investigators
- Jianhua Chang, Principal investigator, Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07101549
- Sponsor's protocol ID
- YW2024-42-3
- Status last verified
- Jul 2025
- First submitted
- 17 Jul 2025
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Single-arm, Dose-escalation Exploratory Clinical Trial on the Safety, Efficacy, and Pharmacokinetics of R-Star001 Cell Injection in Patients With Nectin-4-positive Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07101549
- Acronym / sponsor ID
- YW2024-42-3
- Conditions
- Advanced Solid Tumors
- Keywords
- Nectin-4-positive advanced solid tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- changjianhuaUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 3 Aug 2025 (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.
A single-center, single-arm, dose-escalation exploratory clinical trial on the safety, efficacy, and pharmacokinetics of R-Star001 cell injection in patients with Nectin-4-positive advanced solid tumors.
Detailed description
This study is a prospective, single-center, single-arm, open-label, single-dose administration dose-finding study, which aims to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor efficacy characteristics of the R-Star001 cell injection in subjects with Nectin-4 positive advanced solid tumors.
The study will enroll subjects with pathologically confirmed advanced solid tumors (including, but not limited to breast cancer, urothelial carcinoma, colorectal cancer, head and neck squamous cell carcinoma, ovarian cancer, esophageal cancer, lung cancer) who have failed standard therapy; AND immunohistochemical analysis of histological or cytological tumor specimens demonstrates moderate to high Nectin-4 expression.
This prospective, single-center, single-arm, open-label study employs a single-dose administration design across two sequential stages. Stage 1 (Dose Escalation) utilizes an accelerated titration approach with standard '3+3' dose escalation to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of R-Star001 Cell Injection in subjects with Nectin-4 positive advanced solid tumors, thereby determining expansion dose levels based on integrated cohort data. Stage 2 (Dose Expansion) will enroll up to 9 subjects per cohort (including escalation-phase subjects) at 1-2 selected dose levels to further characterize safety and efficacy. The Recommended Phase II Dose (RP2D) will be determined post-infusion through comprehensive analysis of Stage 1 safety/efficacy outcomes, pharmacokinetic profiles, and prior preclinical/clinical evidence.
Main purpose:
the safety and tolerability of R-Star001 cell injection in patients with Nectin-4 positive advanced solid tumors, and determine the Recommended Phase II Dose (RP2D).
Secondary Purpose:
The pharmacokinetic and pharmacodynamic characteristics of R-Star001 cell injection in patients with Nectin-4 positive advanced solid tumors; To preliminarily evaluate the efficacy of R-Star001 cell injection in patients with Nectin-4 positive advanced solid tumors.
Evaluate the immunogenicity of R-Star001 cell injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nectin-4-targeted CAR T-cell injection with inducing IL-18 secretion | Experimental | Drug: R-Star001Experimental: Phase 1, open-label, single-arm trial. Drug: Nectin-4-targeted CAR T-cell injection with inducing IL-18 secretion. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Voluntarily participate in the clinical trial; fully understand and be informed about this study and sign the informed consent form; be willing to follow and be able to complete all trial procedures;
- At the time of screening, the age should be between 18 and 70 years old (inclusive), regardless of gender;
- Patients with pathologically diagnosed advanced solid tumors (including but not limited to breast cancer, urothelial cancer, colorectal cancer, head and neck squamous cell carcinoma, ovarian cancer, esophageal cancer, pancreatic cancer, non-small cell lung cancer (NSCLC)) who have failed standard treatment;
- The histological or cytological tumor specimens have been confirmed by immunohistochemistry to have high or moderate expression of Nectin-4;
- The patient has at least one measurable lesion (according to the requirements of RECIST version 1.1, the long diameter of the measurable lesion on spiral CT scan is ≥ 10mm or the short diameter of the enlarged lymph node is ≥ 15mm. See Annex 1 for RECIST version 1.1);
Key exclusion criteria (19 listed)
- Pregnant or lactating women;
- Those with a history of allergy to immunotherapy, allergy to related drugs, a history of severe allergies in the past, and allergy to the components of R-Star001;
- Patients with other malignant tumors, except for the following situations: cured non-melanoma skin cancer, in-situ cervical cancer, localized prostate cancer, superficial bladder cancer, and other malignant tumors with a disease-free survival period of more than 3 years;
- Symptomatic intracranial or spinal cord metastasis of the tumor;
- Positive for hepatitis B surface antigen (HBsAg) positive, hepatitis B e-antigen (HBeAg) positive, hepatitis B e-antibody (HBeAb) positive, hepatitis B core antibody (HBcAb) positive, hepatitis C virus antibody (HCV-Ab) positive, anti-Treponema pallidum antibody (TP-Ab) ; subjects meeting any one of the above items;
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 |
|---|---|---|
| R-Star001Drug: Nectin-4-targeted CAR T-cell injection with inducing IL-18 secretion (R-Star001). The trial consists of a traditional '3 + 3' pattern dose-escalation phase and a dose-expansion phase. | Drug | Nectin-4-targeted CAR T-cell injection with inducing IL-18 secretion |
Primary outcome
Dose limiting toxicity (DLT)
Time frame: 28 days of single infusion
Dose limiting toxicity (DLT) in the dose escalation phase
Adverse events (AEs)
Time frame: 1 year
The incidence rate of treatment-emergent adverse events (TEAEs), the incidence rate of treatment-related adverse events, and the incidence rate of adverse events of special interest (AESIs)
Maximum tolerated dose (MTD)
Time frame: 28 days of single infusion
Maximum tolerated dose (MTD) in the dose escalation phase
8 secondary outcomes
Objective response rate (ORR)
Time frame: 1 year
Disease Control Rate (DCR)
Time frame: 1 year
Progression - free survival (PFS)
Time frame: 1 year
Overall survival (OS)
Time frame: 1 year
Immunogenicity
Time frame: 1 year
Cellular pharmacokinetics (Cmax)
Time frame: 1 year
Cellular pharmacokinetics (Tmax)
Time frame: 1 year
Cellular pharmacokinetics (AUC)
Time frame: 1 year
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 3 Aug 2025.
- Individual participant dataSharing planned: No
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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.
Jianhua Chang principal investigator
Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing R-Star001 in people with Advanced Solid Tumors, run by changjianhua at 1 site in China.
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 20 inclusion and 19 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 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Jianhua Chang (86-18038168872, changjianhua@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limiting toxicity (DLT) (time frame: 28 days of single infusion). The study lists 3 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 3 Aug 2025.