SKB105 for Injection in Advanced Solid Tumors

NCT07380386 | Recruiting Phase 1

• 1 other identifier: SKB105-I/II-01
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 2

Brief Summary

This is a Phase 1/2 clinical study to evaluate the safety and efficacy of SKB105 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

Keywords

SKB105; Integrin β6 (ITGB6)

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 first 21 days and is at least possibly related to 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 3 years

Secondary Outcomes (3)

• Progression Free Survival (PFS)

  Up to 3 years

• Duration of Response (DOR)

  Up to 3 years

• Overall Survival (OS)

  Up to 3 years

Study Arms (1)

SKB105 monotherapy

EXPERIMENTAL

Subject will be dosed with SKB105 for injection every 3 weeks(q3w)

Drug: SKB105 for injection Monotherapy

Interventions

SKB105 for injection Monotherapy DRUG

SKB105 for injection monotherapy, iv drip, every 3 weeks (Q3W), until radiographic disease progression (PD), intolerable toxicity, death, or discontinuation of treatment, whichever occurs first.

Also known as: SKB105 Antibody-Drug Conjugate(ADC) in solid tumors

SKB105 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 during the screening period;
• 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.
• 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.
• 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.
• 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)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100021, China

RECRUITING

Shangahi Chest Hospital

Shanghai, Shanghai Municipality, China

NOT YET RECRUITING

Study Officials

• Xiaoping Jin

  STUDY DIRECTOR

Central Study Contacts

Yina Diao

CONTACT

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: January 21, 2026
• First Posted: February 2, 2026
• Study Start: March 5, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2030
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)