NCT06426680

A Study of the ILB-3101 in Patients with Advanced Solid Tumors

Phase I/II Study of the ILB-3101 in Patients with Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Innolake Biopharm · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

ILB-3101 is a fully humanized IgG1 antibody-drug conjugate (ADC) which specifically binds to B7-H3, a target wildly expressed on solid tumor cells. The objectives of this study are to investigate the safety, tolerability, pharmacokinetics and anti-tumor activity of ILB-3101 in Chinese advanced solid tumor patients.

Detailed description

This is an open-label, multi-center, dose-escalation and expansion, first-in-human phase 1 study in Chinese adult participants with locally advanced or metastatic solid tumors. This study will consist of two parts: A Part I dose escalation stage and a Part II dose expansion stage. The objectives of this study are to evaluate the safety, tolerability, PK and preliminary anti-tumor activity, describe the dose-limiting toxicities (DLTs), and determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) of ILB-3101. Part I: Participants with advanced cancer are eligible for dose escalation study if they have progressed on or intolerant to available standard therapies, or no standard or available curative therapy exists. The dose escalation will include an initial accelerated titration design followed by 3+3 design. Part II: Enrollment into dose expansion will begin after identification of the MTD or MAD in Phase I. The dose expansion study will be conducted in populations with the following indications: ovarian cancer, small cell lung cancer, head and neck squamous cell carcinoma, soft tissue sarcoma (including uterine sarcoma), triple negative breast cancer, esophageal squamous cell carcinoma, prostate cancer, etc.. All patients will be carefully followed for adverse events during the study treatment and for 28 days after the last dose of study drug. Subjects will be permitted to continue therapy with assessments for progression if the product is well tolerated and sustained clinical benefit exists.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
BIOLOGICAL	ILB-3101	There are eight escalating dose cohorts.

Timeline

• Start date: 2024-10-30
• Primary completion: 2025-12-01
• Completion: 2026-03-01
• First posted: 2024-05-23
• Last updated: 2024-12-09

Locations

1 site across 1 country: China