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

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: Recruiting
• Conditions: Solid Malignancies
• Intervention / Treatment: Drug: SKB571

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: Interventional
• Enrollment (Estimated): 138
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Xin Li; Phone Number: 086-010-58302512; Email: lixin@kelun.com

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	From data of initial dose until up to 21 days for treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Up to 24 months
Overall Survival (OS)	Time from start of treatment to death due to any reason.	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.	Up to 24 months

Collaborators and Investigators

• Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: November 28, 2024
• First Submitted That Met QC Criteria: December 4, 2024
• First Posted (Actual): December 10, 2024

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID 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