A Study of SKB518 in Patients With Advanced Solid Tumors

NCT06428331 | Recruiting Phase 1

• 1 other identifier: SKB518-I-01
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

This is a first-in-human (FIH), phase 1, multicenter, open-label, dose-escalation study of SKB518 to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity in adult subjects with advanced or metastatic solid tumor relapsed/refractory to standard therapies or for which no effective standard therapy is available.

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 cycle 1 and is at least possibly related to study drug.

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

• Maximum Tolerated Dose (MTD)

  Once the dose escalation stopping criteria are met, the MTD estimated by mTPI-2 will be the dose at which the probability of posterior mean of the DLT rate is between 25% and 35%, closest to 30%, and no more than 35%.

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

Secondary Outcomes (4)

• Objective Response Rate (ORR)

  Up to 24 months

• Progression Free Survival (PFS)

  Up to 24 months

• Duration of Response (DOR)

  Up to 24 months

• Overall Survival (OS)

  Up to 24 months

Study Arms (1)

Dose Escalation

EXPERIMENTAL

Several dose levels are tentatively planned for Phase 1

Drug: SKB518 for injection

Interventions

SKB518 for injection DRUG

SKB518 for injection is administered every 3 weeks (q3w) until radiographic disease progression (PD), intolerable toxicity, death, or discontinuation of treatment, whichever occurs first.

Also known as: SKB518

Dose Escalation

Eligibility Criteria

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

You may qualify if:

• Subject must be at least 18 years of age at the time of signing the informed consent;
• Histological or cytological diagnosis of solid tumor that is advanced/metastatic solid tumor by pathology report and have progressed on, have been intolerant to, or have been ineligible for standard of care treatments.
• Subjects able to provide tumor blocks or 8\~10 slides \[fresh paraffin-embedded tumor tissue or archived paraffin-embedded tumor tissue (maximum time limit is not more than 2 years)\] before the first dose of study intervention for biomarkers testing.
• At least one measurable lesion can be accurately measured per RECIST v1.1 as determined by the local site investigator/radiology assessment. Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
• Subjects with Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
• Life expectancy of at least 3 months as assessed by the investigators.
• Subjects with adequate organ and bone marrow function confirmed by laboratory results within 7 days prior to the first dose.
• Has recovered from all toxicities from previous therapy with the exception of stable, chronic (\>3 months) toxicities not considered a safety risk (e.g. alopecia, vitiligo), after consultation with the Sponsor.
• Subjects of childbearing potential (male or female) must use effective medical contraception during the study until 6 months after the last dose.
• Subjects must be able to provide documented voluntary informed consent.

You may not qualify if:

• Has known active or untreated central nervous system (CNS) metastases and/or carcinomatous meningitis are not eligible.
• Has a known additional malignancy that is progressing or has required active treatment within the past 5 years.
• Has a history of major cardiovascular, cerebrovascular or thromboembolic diseases.
• Has serious and/or uncontrolled concomitant diseases.
• Has known active tuberculosis.
• Has known human immunodeficiency virus (HIV) infection that is not well controlled.
• Has any active viral hepatitis, hepatitis B or hepatitis C.
• Has had major surgery within 28 days prior to the first dose.
• Has known allergy or hypersensitivity to SKB518, or the excipients of SKB518.
• Has a history of interstitial lung disease (ILD) or a history of non-infectious pneumonitis that required steroids.
• Clinically serious lung injuries caused by lung diseases.
• History of documented severe dry eye syndrome.
• Has a history of allogeneic tissue/solid organ transplant.
• Has known uncontrollable effusion.
• Subjects who are vaccinated with live vaccine within 30 days before the first dose, or plan to be vaccinated with live vaccine during the study period.

Sponsors & Collaborators

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

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, China, China

RECRUITING

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Jian Zhang

  Fudan University

  STUDY CHAIR

• Xiaohua Wu

  Fudan University

  STUDY CHAIR

Central Study Contacts

Xiaoping Jin, PhD

CONTACT

86-028-67255165; jinxp@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 20, 2024
• First Posted: May 24, 2024
• Study Start: July 4, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 8, 2026

Record last verified: 2026-05

Locations

CN (1)