A Study of SKB315 in Patients With Advanced Solid Tumors

Phase 1

Recruiting

• Conditions: Advanced Solid Tumors
• Interventions: Drug: SKB315 for injection

• Registration Number: NCT05367635
• Lead Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

Brief Summary

This is a multicenter, open-label, multiple-dose dose finding and expansion study to evaluate the safety, tolerability, pharmacokinetic(PK) profile, and anti-tumor efficacy of SKB315 for injection in patients with advanced solid tumors.

Detailed Description

This is a multicenter, open-label, multiple-dose dose finding and expansion study to evaluate the safety, tolerability, PK profile, and anti-tumor efficacy of SKB315 for injection in patients with advanced solid tumors.The study is divided into Phase 1a and Phase 1b: Phase 1a is a dose escalation study to determine the maximum tolerated dose(MTD); Phase 1b is a dose expansion study to conduct preliminary evaluation of anti-tumor efficacy and further evaluation of safety, tolerability, PK, and immunogenicity of SKB315.

Study Timeline

• Study Start: 2022-03-16
• Study First Submitted: 2022-04-21
• Study First Submitted QC: 2022-05-05
• Study First Posted: 2022-05-10
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-22
• Last Update Posted: 2025-04-27
• Primary Completion: 2025-12-31
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 206

Inclusion Criteria

1. Male or female patients aged 18 to 80 years (inclusive) at the time of signing the informed consent form (ICF);
2. Patients with histologically and/or cytologically confirmed advanced solid tumors who have failed standard of care, or who have no available standard of care regimen, or who are unqualified for standard of care;
3. Consent to provide archival or fresh tumor tissue slides for immunohistochemistry (IHC) assessment, and advanced solid tumors with Claudin 18.2 expression as determined by IHC;
4. Presence of at least one measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1;
5. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1;
6. Estimated survival ≥ 3 months as judged by the investigator;
7. Adequate organ and bone marrow function (no blood components and cytokines are allowed within 2 weeks prior to the first dose) ;
8. Have recovered to ≤ Grade 1 (according to national cancer institute (NCI) common terminology criteria adverse events (CTCAE) V5.0) from previously treated toxicity prior to the first dose of study treatment;
9. Patients of childbearing potential (male or female) must use effective medical contraception during the study and for 6 months after the end of dosing;
10. Patients voluntarily participate in the study, sign the ICF, and will be able to comply with the protocol-specified visits and relevant procedures.

Exclusion Criteria

1. Received other drugs in clinical study, major surgeries, or any other anti-tumor therapies within 4 weeks prior to the first dose of study treatment;
2. Received any previous therapy targeting Claudin18.2;
3. Plan to receive any other anti-tumor therapy during the study;
4. Received strong cytochrome P450 3A4(CYP3A4) inhibitors or inducers within 2 weeks prior to the first dose of study treatment or within 5 half-lives of drug elimination, whichever is longer;
5. Have other malignancies within 5 years prior to signing of ICF;
6. Pregnant or lactating women;
7. Known history of allergy to any component of SKB315 or other monoclonal antibodies (mAbs);
8. Known history of alcohol abuse (consumption of more than 14 units of alcohol per week or drug abuse);
9. Patients with active hepatitis B or hepatitis C;
10. Human immunodeficiency virus (HIV) positive;
11. Active severe digestive disease;
12. History of major cardiovascular diseases
13. Confirmed serious lung disease or lung disease that may impair the respiratory reserve function of the patient as judged by the investigator;
14. History of serious dementia, altered mental status, or any psychiatric disorder;
15. Concomitant or known metastases to brain or central nervous system;
16. Have clinically significant systemic diseases that may adversely affect the safety of the study;
17. Subjects who may have poor compliance with the clinical study or have other factors based on which the investigator considers that the subjects are not appropriate to participate in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Phase 1a：Dose escalation	SKB315 for injection	Eleven dose levels are tentatively planned for Phase 1a
Phase 1b: Dose expansion	SKB315 for injection	The dose of SKB315 for injection in Phase 1b is selected based on the Phase 1a monotherapy dose escalation study.

Primary Outcome Measures

Name	Time	Method
Phase 1b: Objective Response Rate (ORR)	Up to 2 years	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.
Phase 1a: Dose Limiting Toxicities (DLT)	From data of initial dose until up to 21/28 days for treatment	Incidence of Dose Limiting Toxicities

Secondary Outcome Measures

Name	Time	Method
Duration of Response (DOR)	Up to 2 years	DOR: Time from the start of the first assessment of CR or PR in tumor patients to PD or death due to any reason.
Overall Survival (OS)	Up to 2 years	OS: Time from start of treatment to death due to any reason.
Progression Free Survival (PFS)	Up to 2 years	PFS: Time from start of treatment to progression of disease (PD) or death, whichever occurs first, in patients with tumors.

Trial Locations

Locations (1)

Tianjin Medical University Cancer Institute & Hospital; 🇨🇳 Tianjin, Tianjin, China