SKB571 for adults 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 first-in-human Phase 1 test gives SKB571 to adults with advanced or metastatic solid tumors to see if it is safe, how the body handles it, and whether it shows anti-tumor activity.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 138 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy, prednisone
• Locations: 15 sites (Guangzhou, Guangdong and 14 other locations)
• Trial ID: NCT06725381 on ClinicalTrials.gov

What this trial studies

This open-label, multicenter Phase 1 first-in-human trial administers SKB571 to adults with advanced or metastatic solid tumors to characterize safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity. Adult participants must have histologically or cytologically confirmed disease, at least one measurable lesion per RECIST v1.1, ECOG 0–1, adequate organ function, and expected survival ≥3 months. The study is being conducted at multiple cancer centers in China and will collect serial safety labs, imaging, PK sampling, and immune response data. Dose escalation and cohort expansion approaches typical of Phase 1 designs will be used to define tolerable dosing and look for early signs of efficacy.

Who should consider this trial

Good fit: Adults aged 18–75 with confirmed advanced or metastatic solid tumors, measurable disease by RECIST v1.1, ECOG performance 0–1, adequate organ function, and life expectancy of at least 3 months would be appropriate candidates.

Not a fit: Patients with active or untreated central nervous system metastases, recent other malignancies within three years, or significant cardiac comorbidities excluded by the protocol may not benefit or may be ineligible for this treatment.

Why it matters

Potential benefit: If successful, SKB571 could provide a new treatment option that slows tumor growth or shrinks tumors in some patients with advanced solid cancers.

How similar studies have performed: SKB571 is being tested in humans for the first time, so its effects are unproven, although other targeted and immune-modulating agents have shown benefit in some solid tumors.

Eligibility criteria

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.

Where this trial is running

Guangzhou, Guangdong and 14 other locations

• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
• Guangxi Medical University Cancer Hospital — Nanning, Guangxi, China (Recruiting)
• Hubei Cancer Hospital — Wuhan, Hubei, China (Recruiting)
• Hunan Cancer Hospital — Changsha, Hunan, China (Recruiting)
• The Affliated Hospital of Nanjing University Medical School — Nanjing, Jiangsu, China (Recruiting)
• Shandong Cancer Hospital — Jinan, Shandong, China (Recruiting)
• Guangxi Medical University Cancer Hospital — Linyi, Shandong, China (Recruiting)
• Si Chuan Cancer Hospital — Chengdu, Sichuan, China (Recruiting)
• West China Hospital, Sichuan University — Chengdu, Sichuan, China (Recruiting)
• Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (Recruiting)
• Bei Jing Cancer Hospital — Beijing, China (Not_yet_recruiting)
• Chongqing University Cancer Hospital — Chongqing, China (Recruiting)
• Shanghai East Hospital — Shanghai, China (Recruiting)
• Shanghai Pulmonary Hospital — Shanghai, China (Not_yet_recruiting)
• Zhongshan Hospital — Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Xin Li

Conditions Solid Malignancies