SKB565 for Injection in Advanced Solid Tumors

NCT07545265 | Not Yet Recruiting Phase 1

• 1 other identifier: SKB565-I/II-01
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (2)

• Number of subjects achieving Dose-limiting toxicity (DLT)

  DLT is defined as an adverse event (AE) that meets protocol-defined DLT criteria during the first 28 days and is at least possibly related to the study drug.

  Day 1 to Day 28 in Cycle 1 in the dose escalation part

• Objective response rate (ORR)

  To evaluate the ORR of SKB565 as assessed by the investigator based on RECIST v1.1.

  Up to approximately 3 years

Study Arms (1)

SKB565 monotherapy

EXPERIMENTAL

SKB565 will be administered as an intravenous (IV) infusion on Day 1 and Day 15 of each 28-day cycle

Drug: SKB565

Interventions

SKB565 DRUG

IV infusion on Day 1 and Day 15 of each cycle, every 4 weeks (Q4W), until radiographic disease progression (PD), intolerable toxicity, participant request for discontinuation, lost to follow-up, or death (whichever occurs first).

SKB565 monotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

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

Study Sites (2)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510060, China

Location

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510289, China

Location

Central Study Contacts

Yan Qing

CONTACT

028-67255480; qingyan@kelun.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: April 22, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): May 1, 2029
• Last Updated: April 22, 2026

Record last verified: 2026-04

Locations

CN (2)