A Phase 1 Study of SKB571 in Subjects With Advanced Solid Tumors

May 5, 2026 updated by: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

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 .

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
138

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
      • Beijing, China
        • Not yet recruiting
        • Bei Jing Cancer Hospital
        • Contact:
          • Minglei Zhuo
      • Chongqing, China
        • Recruiting
        • Chongqing University Cancer Hospital
        • Contact:
          • Yongsheng Li
      • Shanghai, China
        • Recruiting
        • Zhongshan Hospital
        • Contact:
          • Tianshu Liu
      • Shanghai, China
        • Recruiting
        • Shanghai East Hospital
        • Contact:
          • Ye Guo
      • Shanghai, China
        • Not yet recruiting
        • Shanghai Pulmonary Hospital
        • Contact:
          • Shengxiang Ren
    • Guangdong
      • Guangzhou, Guangdong, China
        • Recruiting
        • Sun Yat-sen University Cancer Center
        • Contact:
          • Li Zhang
        • Contact:
          • Ruihua Xu
    • Guangxi
      • Nanning, Guangxi, China
        • Recruiting
        • Guangxi Medical University Cancer Hospital
        • Contact:
          • Wei Jiang
    • Hubei
      • Wuhan, Hubei, China
        • Recruiting
        • Hubei Cancer Hospital
        • Contact:
          • Bin Yang
    • Hunan
      • Changsha, Hunan, China
        • Recruiting
        • Hunan Cancer Hospital
        • Contact:
          • Zhenyang Liu
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Recruiting
        • The Affliated Hospital of Nanjing University Medical School
        • Contact:
          • Liyun Miao
    • Shandong
      • Jinan, Shandong, China
        • Recruiting
        • Shandong Cancer Hospital
        • Contact:
          • Yuping Sun
      • Linyi, Shandong, China
        • Recruiting
        • Guangxi Medical University Cancer Hospital
        • Contact:
          • Jianhua Shi
    • Sichuan
      • Chengdu, Sichuan, China
        • Recruiting
        • West China Hospital, Sichuan University
        • Contact:
          • lei Liu
        • Contact:
          • Li Zheng
      • Chengdu, Sichuan, China
        • Recruiting
        • Si Chuan Cancer Hospital
        • Contact:
          • Jin Zhou
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Recruiting
        • Zhejiang Cancer Hospital
        • Contact:
          • Zhengbo Song

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Subjects aged 18-75 years at the time of signing the informed consent form
  2. Subjects with histologically or cytologically confirmed locally advanced or metastatic solid tumors .
  3. Subjects with at least one measurable lesion assessed by the investigator according to RECIST v1.1.
  4. Subjects with Eastern Cooperative Oncology Group (ECOG) status score of 0 or 1.
  5. Subjects who are assessed by the investigator to have an expected survival of ≥ 3 months.
  6. Subjects who have adequate organ function.
  7. Subjects who have recovered from all toxicities due to prior therapy .
  8. Male and female subjects must agree to use highly effective contraception methods during the study treatment.
  9. Subjects who voluntarily sign the informed consent form.

Exclusion Criteria:

  1. Subjects with known active or untreated central nervous system (CNS) metastases.
  2. Subjects with other malignant tumors within 3 years prior to the first dose.
  3. Subjects with history of major cardiovascular, cerebrovascular, or thromboembolic disease.
  4. Subjects with known active pulmonary tuberculosis.
  5. Subjects with human immunodeficiency virus (HIV) infection, or any known active viral hepatitis, or hepatitis B or hepatitis C.
  6. Subjects with major surgery within 28 days prior to the first dose.
  7. Subjects with known allergy or hypersensitivity to SKB571 or its excipients.
  8. Subjects with clinically severe lung injuries due to pulmonary complications.
  9. Subjects with a history of allogeneic tissue/solid organ transplant.
  10. Uncontrolled pleural effusion, pericardial effusion, or ascites effusion requiring repeated drainage.
  11. 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.
  12. 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.
  13. Subjects who have received chemotherapy, immunotherapy, or biological therapy within 4 weeks prior to the first dose of study treatment.
  14. Subjects with active infection requiring systemic anti-infective therapy within 14 days prior to the first dose of study treatment.
  15. 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.
  16. Subjects have received an investigational agent or has used an investigational device within 28 days prior to initial dose administration of SKB571.
  17. 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.
  18. Subjects with a known history of psychosis or drug abuse that will preclude the subject from completing the study.
  19. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Dose escalation
Drug: SKB571
SKB571 for injection is administered every 3 weeks (q3w) until radiographic disease progression (PD), intolerable toxicity, death, or discontinuation of treatment, whichever occurs first.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
From data of initial dose until up to 21 days for treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: Up to 24 months
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.
Up to 24 months
Duration of Response (DOR)
Time Frame: Up to 24 months
Time from the start of the first assessment of CR or PR in tumor patients to PD or death due to any reason.
Up to 24 months
Overall Survival (OS)
Time Frame: Up to 24 months
Time from start of treatment to death due to any reason.
Up to 24 months
Progression Free Survival (PFS)
Time Frame: Up to 24 months
Time from start of treatment to progression of disease (PD) or death, whichever occurs first, in patients with tumors.
Up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 17, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 28, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 10, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SKB571-I-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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