Clinical trialPhase 1Terminated
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of LB4330 in Patients With Advanced Solid Tumors（MEETCD8-001）
A Phase I，Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of LB4330 in Patients With Advanced Solid Tumors（MEETCD8-001）
- Outcome
- Stopped earlyDue to adjustments in the sponsor's development strategy, it has been decided to terminate the study. (Business decision)
- Phase
- Phase 1
- Status
- Terminated
- Study type
- Interventional
- Start
- 30 November 2022
- Expected end
- 20 December 2024
- Enrollment
- 40 participants
- Sites
- 1
- Primary outcomes
- MTD/RP2D; DLT occurrence and frequency (dose escalation phase); AE, SAE occurrence and frequency (according to NCI CTCAE 5.0)
- Sponsor
- Industry
- Results posted
- No
- Last update
- 11 September 2025
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Brief summary public domain (ClinicalTrials.gov)
This is a Phase I study designed to evaluate if LB4330, an anti-Claudin 18.2 and CD8 T cell activator fusion protein, is safe, tolerable and efficacious in participants with Advanced Solid Tumors
Detailed description public domain (ClinicalTrials.gov)
This first time in patients, open-label, multi-center study will have LB4330 administered intravenously (IV) in Patients with Advanced Solid Tumors. This study will have 2 parts: Part A which will have dose escalation cohorts and Part B which will have the dose expansion cohorts.