Solid MalignanciesPhase 1NCT06725381
A Phase 1 Study of SKB571 in Subjects With Advanced Solid Tumors
A Phase 1 study testing SKB571 in people with Solid Malignancies, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. at 15 sites in China.
Trial summary
This is a first-in-human (FIH), phase 1, multicenter, open-label study of SKB571 to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity in adult subjects with advanced or metastatic solid tumor . Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Malignancies
- What is being tested?
- SKB571
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 15 sitesChina
- Study dates
- 17 Dec 2024to 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects aged 18-75 years at the time of signing the informed consent form
- Subjects with histologically or cytologically confirmed locally advanced or metastatic solid tumors .
- Subjects with at least one measurable lesion assessed by the investigator according to RECIST v1.1.
- Subjects with Eastern Cooperative Oncology Group (ECOG) status score of 0 or 1.
- Subjects who are assessed by the investigator to have an expected survival of ≥ 3 months.
- Subjects who have adequate organ function.
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- Subjects who have recovered from all toxicities due to prior therapy .
- Male and female subjects must agree to use highly effective contraception methods during the study treatment.
- Subjects who voluntarily sign the informed consent form.
Who cannot join
- Subjects with known active or untreated central nervous system (CNS) metastases.
- Subjects with other malignant tumors within 3 years prior to the first dose.
- Subjects with history of major cardiovascular, cerebrovascular, or thromboembolic disease.
- Subjects with known active pulmonary tuberculosis.
- Subjects with human immunodeficiency virus (HIV) infection, or any known active viral hepatitis, or hepatitis B or hepatitis C.
- Subjects with major surgery within 28 days prior to the first dose.
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- Subjects with known allergy or hypersensitivity to SKB571 or its excipients.
- Subjects with clinically severe lung injuries due to pulmonary complications.
- Subjects with a history of allogeneic tissue/solid organ transplant.
- Uncontrolled pleural effusion, pericardial effusion, or ascites effusion requiring repeated drainage.
- Subjects who have received live vaccines within 30 days prior to the first dose of study treatment, or who are scheduled to receive live vaccines during the study.
- Subjects who have received strong cytochrome P450 (CYP3A4) inhibitors or inducers, or BCRP inhibitors within 2 weeks prior to the first dose of study treatment or within 5 half-lives of known drug, whichever is longer.
- Subjects who have received chemotherapy, immunotherapy, or biological therapy within 4 weeks prior to the first dose of study treatment.
- Subjects with active infection requiring systemic anti-infective therapy within 14 days prior to the first dose of study treatment.
- Subjects with any disease requiring systemic treatment with corticosteroids (prednisone at doses > 10 mg/d or similar drugs with equivalent doses) or other immunosuppressive therapy within 14 days prior to the first dose of study treatment.
- Subjects have received an investigational agent or has used an investigational device within 28 days prior to initial dose administration of SKB571.
- Subjects whose condition deteriorates rapidly before the first dose, such as a severe physical impariment or a change in ECOG score no longer meeting the inclusion criteria.
- Subjects with a known history of psychosis or drug abuse that will preclude the subject from completing the study.
- Any condition that, in the opinion of the investigator, will interfere with the assessment of study treatment or the safety of the subject or the interpretation of the study results.
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
15 sites in 1 country
China15 sites, 15 recruiting
- Not yet recruiting
Bei Jing Cancer Hospital
Beijing
Minglei Zhuo
- Recruiting
Hunan Cancer Hospital
Changsha, Hunan
Zhenyang Liu
- Recruiting
Si Chuan Cancer Hospital
Chengdu, Sichuan
Jin Zhou
- Recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan
li Zheng
lei Liu
- Recruiting
Chongqing University Cancer Hospital
Chongqing
Yongsheng Li
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong
Ruihua Xu
Li Zhang
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang
Zhengbo Song
- Recruiting
Shandong Cancer Hospital
Jinan, Shandong
Yuping Sun
- Recruiting
Guangxi Medical University Cancer Hospital
Linyi, Shandong
Jianhua Shi
- Recruiting
The Affliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu
Liyun Miao
- Recruiting
Guangxi Medical University Cancer Hospital
Nanning, Guangxi
Wei Jiang
- Recruiting
Shanghai East Hospital
Shanghai
Ye Guo
- Not yet recruiting
Shanghai Pulmonary Hospital
Shanghai
Shengxiang Ren
- Recruiting
Zhongshan Hospital
Shanghai
Tianshu Liu
- Recruiting
Hubei Cancer Hospital
Wuhan, Hubei
Bin Yang
About this study
Official title: A Phase 1 Clinical Study of the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of SKB571 for Injection in Subjects With Advanced Solid Tumors
This is a first-in-human (FIH), phase 1, multicenter, open-label study of SKB571 to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity in adult subjects with advanced or metastatic solid tumor .
Read the detailed description
This is a first-in-human (FIH), phase 1, multicenter, open-label study of SKB571 to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity in adult subjects with advanced or metastatic solid tumor.
- Conditions
- Solid Malignancies
- Being tested
- SKB571
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SKB571Drug
SKB571 for injection is administered every 3 weeks (q3w) until radiographic disease progression (PD), intolerable toxicity, death, or discontinuation of treatment, whichever occurs first.
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation | Experimental | Not described Receives: Drug: SKB571 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects achieving Dose-limiting toxicity (DLT)
DLT is defined as an adverse event (AE) that meets protocol defined DLT criteria during cycle 1 and is at least possibly related to study drug.
Measured: From data of initial dose until up to 21 days for treatment
Secondary outcomes (4)
Objective Response Rate (ORR)
The sum of the number of cases with Complete Response (CR) and Partial Response (PR) in all treated tumor patients (CR + PR) divided by the total number of cases.
Measured: Up to 24 months
Progression Free Survival (PFS)
Time from start of treatment to progression of disease (PD) or death, whichever occurs first, in patients with tumors.
Measured: Up to 24 months
Duration of Response (DOR)
Time from the start of the first assessment of CR or PR in tumor patients to PD or death due to any reason.
Measured: Up to 24 months
Overall Survival (OS)
Time from start of treatment to death due to any reason.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start17 Dec 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid MalignanciesStudies of the same condition, open and under way.
- More trials run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.The 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06725381
- Sponsor's protocol ID
- SKB571-I-01
- Status last verified
- May 2026
- First submitted
- 28 Nov 2024
- Last updated
- 8 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 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Clinical Study of the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of SKB571 for Injection in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06725381
- Acronym / sponsor ID
- SKB571-I-01
- Conditions
- Solid Malignancies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Dec 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 10 Dec 2024 (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 is a first-in-human (FIH), phase 1, multicenter, open-label study of SKB571 to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity in adult subjects with advanced or metastatic solid tumor .
Detailed description
This is a first-in-human (FIH), phase 1, multicenter, open-label study of SKB571 to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity in adult subjects with advanced or metastatic solid tumor.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose escalation | Experimental | Drug: SKB571 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects aged 18-75 years at the time of signing the informed consent form
- Subjects with histologically or cytologically confirmed locally advanced or metastatic solid tumors .
- Subjects with at least one measurable lesion assessed by the investigator according to RECIST v1.1.
- Subjects with Eastern Cooperative Oncology Group (ECOG) status score of 0 or 1.
- Subjects who are assessed by the investigator to have an expected survival of ≥ 3 months.
Key exclusion criteria (19 listed)
- Subjects with known active or untreated central nervous system (CNS) metastases.
- Subjects with other malignant tumors within 3 years prior to the first dose.
- Subjects with history of major cardiovascular, cerebrovascular, or thromboembolic disease.
- Subjects with known active pulmonary tuberculosis.
- Subjects with human immunodeficiency virus (HIV) infection, or any known active viral hepatitis, or hepatitis B or hepatitis C.
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 |
|---|---|---|
| SKB571SKB571 for injection is administered every 3 weeks (q3w) until radiographic disease progression (PD), intolerable toxicity, death, or discontinuation of treatment, whichever occurs first. | Drug | Dose escalation |
Primary outcome
Number of subjects achieving Dose-limiting toxicity (DLT)
Time frame: From data of initial dose until up to 21 days for treatment
DLT is defined as an adverse event (AE) that meets protocol defined DLT criteria during cycle 1 and is at least possibly related to study drug.
4 secondary outcomes
Objective Response Rate (ORR)
Time frame: Up to 24 months
Progression Free Survival (PFS)
Time frame: Up to 24 months
Duration of Response (DOR)
Time frame: Up to 24 months
Overall Survival (OS)
Time frame: Up to 24 months
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 8 May 2026.
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
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A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
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IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
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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.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SKB571 in people with Solid Malignancies, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. at 15 sites 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 9 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: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites 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 Xin Li (086-010-58302512, lixin@kelun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects achieving Dose-limiting toxicity (DLT) (time frame: From data of initial dose until up to 21 days for treatment). 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 8 May 2026.