Spots Global Cancer Trial Database for A Study of ILB2109 and Toripalimab in Patients With Advanced Solid Malignancies

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Trial Identification

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

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

Study ID: NCT05955105

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

ILB-2109

Toripalimab

Study Description

Brief 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.