RecruitingPhase 2NCT06839066
A Phase II Study to Evaluate HLX43 in Subjects With Recurrent/Metastatic Nasopharyngeal Carcinoma Failed or Intolerance to Second-line Therapy
A Phase II Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) in Subjects With Recurrent/Metastatic Nasopharyngeal Carcinoma (NPC) Failed or Intolerance to Second-line Therapy
Sponsor
Shanghai Henlius Biotech
Enrollment
70 participants
Start Date
Apr 2, 2025
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria11
- 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;
- Age ≥ 18 years at the time of signing the ICF, regardless of gender;
- Histologically or cytologically confirmed recurrent/metastatic nasopharyngeal carcinoma;
- 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;
- At least one measurable lesion per RECIST v1.1 within 4 weeks before randomization;
- Willing to provide archived (preferably within 2 years) or fresh tumor tissue specimens for the detection of PD-L1 expression.
- At least 4 weeks (or 5 half-lives, whichever is shorter) since last major surgery, medical device treatment, radiotherapy (except palliative bone radiotherapy), cytotoxic chemotherapy, immunotherapy, or biological therapy; ≥2 weeks since last hormonal therapy or small molecule targeted therapy; ≥1 week since last traditional Chinese medicine treatment with anti-tumor indications or minor surgery; with treatment-related adverse events recovered to CTCAE v5.0 ≤ grade 1 (except grade 2 peripheral neuropathy and alopecia);
- ECOG performance status 0-1 within 1 week before randomization;
- Expected survival ≥ 3 months；
- Adequate organ function within 1 week before randomization (no blood transfusion or colony-stimulating factors within 14 days prior to first dose)
- Fertile participants must use ≥1 highly effective contraceptive method during the trial and for ≥6 months after last dose; females of childbearing potential must have negative pregnancy test within 7 days before enrollment.
Exclusion Criteria20
- Recurrent nasopharyngeal carcinoma candidates eligible for curative local therapy (surgery or radiotherapy).
- Imaging showing tumor invasion/encasement of major thoracic/cervical/pharyngeal blood vessels (may be exempted if investigators confirm no impact on trial participation).
- History of other malignancies within 2 years prior to randomization (except radically treated early-stage malignancies).
- Previous ≥Grade 3 immune-related adverse events during immunotherapy.
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
- Symptomatic/untreated/progressing CNS or leptomeningeal metastases.
- History of ≥Grade 3 radiation pneumonitis; steroid-requiring (non-infectious) interstitial lung disease (ILD), current ILD, or ILD unexcludable by imaging; or severe respiratory impairment from pulmonary disease.
- Poorly controlled cardiovascular/cerebrovascular conditions including.
- Candidates for organ/marrow transplantation or previous transplant recipients.
- Active systemic infections requiring IV antibiotics within 2 weeks pre-randomization.
- Use of strong CYP2D6/CYP3A inhibitors/inducers within 2 weeks pre-randomization.
- Systemic corticosteroid use (\>10mg prednisone/day equivalent) or immunosuppressants within 2 weeks pre-randomization. Exceptions: Topical/ocular/intra-articular/nasal/inhaled steroids; short-term prophylactic use for contrast agents.
- Active/suspected autoimmune diseases. Exceptions: Hypothyroid patients on thyroid replacement; controlled type 1 diabetes with insulin.
- Live/attenuated vaccines within 4 weeks pre-randomization (inactivated influenza vaccines permitted).
- History of severe hypersensitivity to biologics/monoclonal antibodies or trial drug components.
- Active tuberculosis.
- Immunodeficiency disorders (HIV-positive or congenital/acquired immune deficiencies).
- Active HBV/HCV infection or co-infection:
- Pregnant/lactating women.
- Investigators' judgment of clinical/lab abnormalities or other factors making participation inappropriate.
Interventions
DRUGHLX43 DOSE 1
HLX43 is an anti-PD-L1 monoclonal antibody conjugated with a novel high potency DNA topoisomerase I (topo I) inhibitor, with a drug-antibody-ratio (DAR) of 8.
DRUGHLX43 DOSE 2
HLX43 is an anti-PD-L1 monoclonal antibody conjugated with a novel high potency DNA topoisomerase I (topo I) inhibitor, with a drug-antibody-ratio (DAR) of 8.
DRUGHLX43 DOSE 3
HLX43 is an anti-PD-L1 monoclonal antibody conjugated with a novel high potency DNA topoisomerase I (topo I) inhibitor, with a drug-antibody-ratio (DAR) of 8.
Locations(15)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06839066
Related Trials
Becotatug Vedotin Plus Sintilimab in Locoregionally Advanced NPC
NCT074592961 location
Sapylin Versus Dexamethasone Inhalation for CCRT-Induced Oral Mucositis in Nasopharyngeal Carcinoma
NCT073272161 location
Iparomlimab and Tuvonralimab Combined With Nimotuzumab in Recurrent or Metastatic NPC After First-line Treatment Failure: A Single-arm Phase IIa Clinical Trial
NCT071017441 location
Proton vs Photon IMRT in Locally Advanced Nasopharyngeal Carcinoma: A Phase III Trial
NCT073405151 location
Reduced-dose Versus Conventional-dose Intensity-modulated Radiation Therapy for Locally Advanced Nasopharyngeal Carcinoma With Remission After Induction Chemotherapy and Immunotherapy
NCT0732884112 locations