OncoMatch/Clinical Trials/NCT05955105
A Study of ILB2109 and Toripalimab in Patients With Advanced Solid Malignancies
Is NCT05955105 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies multiple treatments including ILB-2109 and Toripalimab for head and neck cancer.
Treatment: ILB-2109 · Toripalimab — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Other
Cancer type
Head and Neck Squamous Cell Carcinoma
Cervical Cancer
Endometrial Cancer
Triple-Negative Breast Cancer
Breast Carcinoma
Ovarian Cancer
Sarcoma
Melanoma
Non-Small Cell Lung Carcinoma
Hodgkin Lymphoma
Disease stage
Metastatic disease required
advanced, metastatic and or progressive
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Cannot have received: systemic anti-tumor therapy
Exception: nitrosoureas or mitomycin C in past 6 weeks; oral fluorouracil or small molecule targeted therapy or Chinese Traditional Medicine (CTM) with anti-neoplasm indication in past 2 weeks
In the past 3 weeks: received systemic anti-tumor therapy, including chemotherapy, radiation, biologics, androgen, targeted therapy and immunotherapy with the following exceptions: i. received treatment containing nitrosoureas or mitomycin C in the past 6 weeks; ii. received oral fluorouracil or small molecule targeted therapy or Chinese Traditional Medicine (CTM) with anti-neoplasm indication in the past 2 weeks
Cannot have received: investigational treatment
In the past 4 weeks: received any other investigational treatment
Lab requirements
Blood counts
ANC ≥1.5 x 10^9/L; Platelets ≥75 x 10^9/L; Hemoglobin ≥90g/L
Kidney function
Estimated GFR >50 mL/min (Cockcroft-Gault)
Liver function
Total bilirubin <1.5x ULN; AST ≤3x ULN (≤5x ULN if hepatic malignancies); ALT ≤2.5x ULN (≤5x ULN if hepatic malignancies)
Cardiac function
LVEF ≥50%; QTcF: male<450ms, female<470ms
Absolute neutrophil count ≥1.5 x 10^9/L; Platelets ≥75 x 10^9/L; Hemoglobin ≥ 90g/L; Total bilirubin <1.5 times the upper limit of normal; AST ≤3 times the upper limit of normal, ≤ 5 times the upper limit of normal if subject has hepatic malignancies; ALT ≤2.5 times the upper limit of normal, ≤ 5 times the upper limit of normal if subject has hepatic malignancies; Estimated GFR of >50 mL/min (Cockcroft-Gault); INR and aPTT ≤1.5x ULN; LVEF ≥ 50%; QTcF: male<450ms, female<470ms
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT05955105 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior systemic anti-tumor therapy, investigational treatment disqualifies patients from enrollment.
Is there an age limit?
Yes. Patients must be 80 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify