OncoMatch/Clinical Trials/NCT06194656
Clinical Trial of SIBP-03 in Patients With Head and Neck Squamous Cell Carcinoma
Is NCT06194656 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including HER3 Monoclonal antibodies-Dose A and HER3 Monoclonal antibodies-Dose B for head and neck squamous cell carcinoma.
Treatment: HER3 Monoclonal antibodies-Dose A · HER3 Monoclonal antibodies-Dose B · HER3 Monoclonal antibodies-Dose C · Cetuximab — This phase II study will be conducted in two parts (Ⅱa and Ⅱb), with a 21-day treatment cycle until disease progression, intolerable toxicity, withdrawal of informed consent, death, initiation of new anti-tumor treatment or loss of follow-up.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Other
Cancer type
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Required: PD-L1 (CD274) any tested (testing required; no eligibility threshold specified)
subjects must provide tumor tissues and blood samples for biomarker detection
Disease stage
Metastatic disease required
There must be at least one measurable lesion as the target lesion (according to RECIST v1.1 standard)
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Must have received: anti-PD-1 therapy
progressed or intolerant after previous immunotherapy containing anti-PD-1/anti-PD-L1
Must have received: anti-PD-L1 therapy
progressed or intolerant after previous immunotherapy containing anti-PD-1/anti-PD-L1
Must have received: platinum-based chemotherapy
progressed or intolerant after previous immunotherapy containing anti-PD-1/anti-PD-L1 and platinum
Cannot have received: HER3-targeted therapy
The participant has received any HER3 targeting ... therapy in the past
Cannot have received: EGFR-targeted therapy
The participant has received any ... EGFR targeting therapy in the past
Lab requirements
Blood counts
The laboratory test results meet the requirements.
Kidney function
The laboratory test results meet the requirements.
Liver function
The laboratory test results meet the requirements.
Cardiac function
QTcF > 450 ms (male) or > 470 ms (female) excluded; LVEF < 50% excluded
The laboratory test results meet the requirements. During the screening period, 12-lead electrocardiogram (ECG) ... QTcF > 450 milliseconds (male) or (QTcF) > 470 milliseconds (female); LVEF of cardiac ultrasound was less than 50%.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06194656 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior HER3-targeted therapy, EGFR-targeted therapy disqualifies patients from enrollment.
Does this trial require CD274?
Yes, CD274 any tested is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 75 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