SKB571 for adults with advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: Xin Li
• Email: lixin@kelun.com
• Phone: 086-010-58302512

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Theranostic PET for target validation and tumor detection in solid cancers

  This is an observational effort to see how theranostic PET scans reflect tumor targets and help with staging, restaging, and treatment planning for adults with solid cancers.

  Recruiting University Hospital, Essen · Essen · NCT07664410

• Cold exposure with PD-1/PD-L1 immunotherapy in solid tumors

  This phase 1 study tests whether adding controlled cold exposure to standard PD-1/PD-L1 therapy is safe and feasible in adults with solid tumors.

  Recruiting Phase 1 West China Hospital · Chengdu, Sichuan · NCT07538479

• 177Lu-IM-3050, a targeted radiopharmaceutical for advanced solid tumors.

  This trial will test whether the targeted radioactive drug 177Lu-IM-3050 is safe and can shrink FAP-positive advanced solid tumors in adults who have not responded to standard treatments.

  Recruiting at 5 sites Phase 1 Immunome, Inc. · Dothan, Alabama and 4 other locations · NCT07505771

• CMAB017 for safety and tolerability in advanced solid tumors

  This trial tests whether the experimental antibody CMAB017 is safe and tolerated in adults with advanced solid tumors who have exhausted or declined standard treatments.

  Recruiting Phase 1 Taizhou Mabtech Pharmaceutical Co.,Ltd · Shanghai · NCT06933069

• Testing IM-1021 for advanced cancer treatment

  This study is testing a new treatment called IM-1021 to see if it can safely help people with advanced cancer feel better.

  Recruiting at 24 sites Phase 1 Immunome, Inc. · Duarte, California and 23 other locations · NCT06823167

• Exploring a new imaging tracer for cancer detection

  This study is testing a new imaging tracer to see if it can help doctors find cancer in patients with tumors using special scans.

  Recruiting Affiliated Hospital of Jiangnan University · Wuxi, Jiangsu · NCT06684028

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.