A Phase II Study to Evaluate HLX43 in Subjects With Recurrent/Metastatic Nasopharyngeal Carcinoma Failed or Intolerance to Second-line Therapy
Trial Parameters
Brief Summary
The study is to explore the reasonable dosage and to evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) in patients with recurrent/metastatic Nasopharyngeal Carcinoma (NPC) who failed or are intolerant to second-line herapy.
Eligibility Criteria
Inclusion Criteria: 1. Fully understand the study content, procedures, and potential adverse reactions before the trial, sign the informed consent form (ICF), voluntarily participate in the trial, and be able to complete the study per the protocol requirements; 2. Age ≥ 18 years at the time of signing the ICF, regardless of gender; 3. Histologically or cytologically confirmed recurrent/metastatic nasopharyngeal carcinoma; 4. Recurrent/metastatic nasopharyngeal carcinoma patients who have failed or are intolerant to at least two prior lines of chemotherapy (including at least one platinum-based regimen) and PD-1/PD-L1 inhibitor therapy. Intolerance is defined as experiencing CTCAE ≥ grade 3 adverse events; 5. At least one measurable lesion per RECIST v1.1 within 4 weeks before randomization; 6. Willing to provide archived (preferably within 2 years) or fresh tumor tissue specimens for the detection of PD-L1 expression. 7. At least 4 weeks (or 5 half-lives, whichever is shorter) since la