RecruitingPhase 1Phase 2NCT05955105

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


Sponsor

Innolake Biopharm

Enrollment

200 participants

Start Date

Jul 25, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two drugs — ILB2109 and toripalimab (an immunotherapy) — in people with advanced solid tumors that have progressed on all other available standard treatments. This is an early-phase study to evaluate safety, tolerability, and signs of effectiveness. **You may be eligible if...** - You are 18 to 80 years old with confirmed advanced, metastatic, or progressive solid cancer - There are no more effective standard therapies available for your cancer - Your overall health (ECOG ≤2) and organ function are adequate - You have measurable or evaluable cancer on imaging or via tumor markers **You may NOT be eligible if...** - You are HIV positive or have active hepatitis B or C, syphilis, or active tuberculosis - You have had a severe immune reaction (grade 3 or above) from prior immunotherapy - You have active autoimmune disease requiring systemic treatment in the past 2 years - You have uncontrolled diabetes, high blood pressure, or interstitial lung disease - You have had a recent heart attack, severe heart failure, or serious arrhythmia in the past 6 months - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGILB-2109

ILB-2109 tablets will be administered by mouth every day in 21-day cycles

DRUGToripalimab

Toripalimab injection will be administered via IV every 21 days.


Locations(1)

Shandong Cancer Hospital

Jinan, Shandong, China

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NCT05955105


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