NCT05821777

A Study to Evaluate Safety, Tolerability and Preliminary Activity of LB101 in Participants With Advanced Solid Tumors

A Phase 1/2a, First in Human, Open-Label, Multicenter, Dose Escalation Study With Expansion Cohorts to Evaluate the Safety, Tolerability, and Preliminary Activity of LB101 in Subjects With Advanced Solid Tumors

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Centessa Pharmaceuticals (UK) Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess safety, tolerability, and preliminary activity of LB101 monotherapy in participants with advanced solid tumors.

Detailed description

This study consists of 2 parts: First in Human (FIH) dose escalation and dose optimization (Part 1a and Part 1b, respectively) and dose expansion (Part 2). Part 1 will evaluate LB101 monotherapy in participants with selected, advanced solid tumors and determine the Recommended Dose(s) for Expansion (RDE(s)) for Part 2. The design of Part 2 depends on the results of Part 1 and will further evaluate the safety, efficacy, tolerability, pharmacokinetics, and immune response of LB101.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	LB101	Part 1: IV infusion of LB101 Q2W (28-day cycle) and Part 2: IV infusion of LB101

Timeline

• Start date: 2023-03-28
• Primary completion: 2025-01-24
• Completion: 2025-09-09
• First posted: 2023-04-20
• Last updated: 2025-09-25

Locations

7 sites across 2 countries: United States, France

Regulatory

• FDA-regulated drug study