Trials / Recruiting
RecruitingNCT05367635
A Study of SKB315 in Patients With Advanced Solid Tumors
A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of SKB315 for Injection in Patients With Advanced Solid Tumors Expressing Claudin18.2
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 246 (estimated)
- Sponsor
- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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 （monotherapy）is a dose expansion study to conduct preliminary evaluation of anti-tumor efficacy and further evaluation of safety, tolerability, PK, and immunogenicity of SKB315.Phase 1b（combination with Tagitanlimab and Capecitabine） is designed to evaluate the efficacy and safety of SKB315 combination with Tagitanlimab and Capecitabine in CLDN18.2-positive of patients with locally advanced, recurrent, or metastatic gastric and esophagogastric junction adenocarcinoma.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2022-03-16
- Primary completion
- 2026-06-30
- Completion
- 2028-06-30
- First posted
- 2022-05-10
- Last updated
- 2025-11-17
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05367635. Inclusion in this directory is not an endorsement.