SKB103 for Injection in Advanced Solid Tumors

NCT07459998 | Recruiting Phase 1

• 1 other identifier: SKB103-I/II-01
• Study Type: interventional
• Target: 277
• Locations: 1 country
• Sites: 2

Brief Summary

This is a phase 1/2 clinical study to evaluate the safety and efficacy of SKB103 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 21 days and is at least possibly related to the study drug.

  From date of initial dose until up to 21 days for treatment

• 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 approximately 3 years

Secondary Outcomes (4)

• Progression Free Survival (PFS)

  Up to approximately 3 years

• Duration of Response (DOR)

  Up to approximately 3 years

• Overall Survival (OS)

  Up to approximately 3 years

• Maximum observed plasma concentration (Cmax) of SKB103-ADC, SKB103-TAB, and free KL610348.

  Up to approximately 3 years

Study Arms (1)

SKB103 monotherapy

EXPERIMENTAL

Participants will be dosed with SKB103 for injection every 3 weeks(q3w)

Drug: SKB103 for injection monotherapy

Interventions

SKB103 for injection monotherapy DRUG

IV infusion on Day 1 of each cycle, every 3 weeks (Q3W), until radiographic disease progression (PD), intolerable toxicity, participant request for discontinuation, lost to follow-up, or death (whichever occurs first).

SKB103 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.
• Participants should provide tumor tissue samples for biomarker testing as much as possible.
• 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 effusion, pericardial effusion, or ascites with clinical symptoms or requiring repeated drainage (\>1 time/week).
• 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 meibomian gland disease and/or blepharitis, or a history of corneal diseases that hinder/delay corneal healing.
• There is a risk of developing esophagotracheal fistula or esophageal pleural fistula, or tumor invasion or compression of surrounding important organs and blood vessels accompanied by related clinical symptoms.
• Within 3 months prior to the first administration, there have been clinical symptoms of 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 4 weeks before 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)

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150001, China

RECRUITING

Shanghai East Hospital, Tongj.University

Shanghai, Shanghai Municipality, 200123, China

RECRUITING

Central Study Contacts

Yina Diao

CONTACT

86-028-67252634; diaoyina@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: March 4, 2026
• First Posted: March 10, 2026
• Study Start: April 23, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2030
• Last Updated: May 18, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)