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A Study of SKB315 in Patients With Advanced Solid Tumors

NCT05367635 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 246

Last updated 2026-05-08

No results posted yet for this study

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.

Conditions

Interventions

DRUG

SKB315 for injection

SKB315 for injection is an Antibody Drug Conjugates (ADC) drug targeting Claudin18.2. The strength of SKB315 is 200 mg/vial.

DRUG

Drug: Tagitanlimab Drug: Capecitabine

Sponsors & Collaborators

  • Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yi Ba, Professor · Tianjin Medical University Cancer Institute and Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-16
Primary Completion
2026-06-30
Completion
2028-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05367635 on ClinicalTrials.gov