SKB118 Injection in Advanced Solid Tumors

NCT07586943 | Not Yet Recruiting Phase 1

• 1 other identifier: SKB118-I/II-01
• Study Type: interventional
• Target: 332
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase 1/2 clinical study to evaluate the safety and efficacy of SKB118 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 SKB118

  Up to approximately 3 years

Study Arms (1)

SKB118 Injection monotherapy

EXPERIMENTAL

Subject will be dosed with SKB118 Injection every 3 weeks(q3w)

Drug: SKB118 Injection

Interventions

SKB118 Injection DRUG

SKB118 Injection monotherapy, iv drip, every 3 weeks (Q3W), until radiographic disease progression (PD), intolerable toxicity, death, or discontinuation of treatment, whichever occurs first.

SKB118 Injection 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.
• 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.
• Screening imaging shows that the tumor encases important blood vessels or exhibits obvious necrosis or cavities, and the investigator determines that study enrollment would pose a risk of bleeding.
• Previous or concurrent gastrointestinal perforation, surgical and wound healing complications, and bleeding events.
• 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.
• Have experienced ≥ Grade 3 immune-related adverse events (irAEs) during prior immunotherapy.
• 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.

Sponsors & Collaborators

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

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200123, China

Location

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: May 7, 2026
• First Posted: May 14, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2030
• Last Updated: May 14, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)