NCT05955105

A Study of ILB2109 and Toripalimab in Patients With Advanced Solid Malignancies

A Phase Ib/IIa, Multicenter, Open-label Study of ILB2109 and Toripalimab in Patients With Advanced Solid Malignancies

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Innolake Biopharm · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, open-label, phase Ib/IIa study. The first part of the study will evaluate the safety, tolerability and preliminary efficacy of ILB2109 and Toripalimab in patients with locally advanced or metastatic solid malignancies. The second part of the study will evaluate the efficacy of ILB2109 and Toripalimab in patients with selected advanced solid malignancies.

Detailed description

This is a two-part study consists of dose escalation and expansion in selected indications. The dose escalation part adopts a 3+3 protocol design and consists of 2 cohorts. Based on the data obtained from the escalation study, selected dose cohort will be expanded in 10 tumor types to further investigate the efficacy of the combination therapy. Subjects will be assessed for safety and efficacy outcomes at pre-specified time points.

Conditions

• Head and Neck Cancer
• Cervical Cancer
• Endometrial Cancer
• Triple Negative Breast Cancer
• Ovarian Cancer
• Soft Tissue Sarcoma
• Melanoma
• Nasopharyngeal Carcinoma
• Non Small Cell Lung Cancer
• Classic Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	ILB-2109	ILB-2109 tablets will be administered by mouth every day in 21-day cycles
DRUG	Toripalimab	Toripalimab injection will be administered via IV every 21 days.

Timeline

• Start date: 2023-07-25
• Primary completion: 2026-01-25
• Completion: 2026-07-24
• First posted: 2023-07-21
• Last updated: 2024-05-21

Locations

1 site across 1 country: China