SKB565 for Injection in Advanced Solid Tumors

Starting soon · Phase 1/Phase 2

Conditions studied: Advanced Solid Tumors

In brief

This is a phase I/II clinical study to evaluate the safety and efficacy of SKB565 in participants with advanced solid tumors. The study includes a dose escalation stage, a dose expansion stage, and a indication expansion stage.

Key facts

Study ID

NCT07545265

Run by

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

People needed

180

Starts

2026-09-01

Expected to finish

2029-08-01

Last updated by the study team

2026-07-31

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants voluntarily joined this study and signed an informed consent form.
• The age at the time of signing the informed consent form must be between 18 and 75 years.
• Participants with histologically or cytologically confirmed advanced solid tumors who have failed standard therapy, have no standard therapy available, or are intolerant to standard therapy.
• Researchers evaluated based on Response Evaluation Criteria in Solid Tumors(RECIST) Version 1.1 that there is at least one measurable lesion present.
• Eastern Cooperative Oncology Group (ECOG) score is 0 or 1.
• Expected survival period ≥ 12 weeks.
• Participants have sufficient bone marrow, liver, kidney, and coagulation functions.
• Male and female participants must agree to use highly effective contraceptive methods during the study period.

You may not qualify if…

• Participants known to have meningeal metastasis, brainstem metastasis, spinal cord metastasis and/or compression, and active central nervous system (CNS) metastasis.
• Patients with other malignant tumors within 3 years before the first administration.
• There are serious heart or vascular diseases or high-risk factors present.
• According to researchers' judgment, it is an uncontrollable systemic disease.
• There are pleural, pericardial, or ascitic effusions that are poorly controlled, symptomatic, or requiring repeated drainage.
• History of interstitial lung disease or non infectious pneumonia.
• There are other lung diseases that may interfere with drug-related pulmonary toxicity.
• Severe dry eye syndrome, severe conjunctivitis, severe meibomian gland disease and/or blepharitis, or a history of corneal diseases that hinder/delay corneal healing.
• Presence of esophagotracheal fistula or esophagoaortic fistula, or tumor invasion or compression of surrounding vital organs and blood vessels accompanied by corresponding clinical symptoms.
• Within 3 months prior to the first administration, there have been intestinal obstruction, gastrointestinal perforation or fistula, urethral fistula, and abdominal abscess.
• The toxicity of previous anti-tumor treatments has not been relieved, defined as the toxicity has not recovered to Common Terminology Criteria for Adverse Events (CTCAE) Version 6.0 grade 0 or 1.
• Serious infection occurred within 28 days prior to the first administration.
• Active hepatitis B or C, or simultaneous infection with Hepatitis B virus(HBV) and Hepatitis C virus(HCV).
• Human immunodeficiency virus (HIV) test is positive or there is a history of acquired immunodeficiency syndrome (AIDS); Known active syphilis infection.
• Known active pulmonary tuberculosis.
• Known history of allogeneic organ transplantation or hematopoietic stem cell transplantation.
• History of allergies to any components of SKB565 injection or severe hypersensitivity reactions to other monoclonal antibodies.
• Received chemotherapy, immunotherapy, biological therapy, or other large-molecule antitumor drugs within 28 days prior to the first administration. Received small-molecule targeted therapy or approved antitumor Chinese patent medicine preparations within 14 days prior to the first administration.
• Within 6 months prior to the first administration, lung lesions received radiation therapy with a total dose greater than 30 Gray.
• Have undergone major surgical procedures or suffered serious injuries within 28 days prior to the first administration.
• Those who have received treatment with other clinical investigational drugs within 28 days prior to the first administration.
• Individuals who have previously received anti-tumor vaccines or have received any active vaccines within 28 days prior to the first administration.
• Pregnant or lactating women.
• Participants with a known history of mental illness or substance abuse are unable to cooperate in completing the study.
• Suffering from local or systemic diseases caused by non malignant tumors, or diseases or symptoms secondary to tumors, which may affect compliance.

Where it is running

• Guangdong Provincial People's Hospital — Guangzhou, Guangdong, China
• Sun Yat-sen Memorial Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China

Full record on ClinicalTrials.gov

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