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New treatment option for Nasopharyngeal Carcinoma (NPC)
Official title A Phase II Study to Evaluate HLX43 in Subjects With Recurrent/Metastatic Nasopharyngeal Carcinoma Failed or Intolerance to Second-line Therapy
ClinicalTrials.gov ID: NCT06839066
What this study is testing
What is HLX43 DOSE 1?
HLX43 DOSE 1 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for nasopharyngeal carcinoma (npc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Fully understand the study content, procedures, and potential adverse reactions before the trial, sign the informed consent form (ICF), voluntarily...
- 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...
- At least one measurable lesion per RECIST v1.1 within 4 weeks before randomization;
You likely can't join if
- 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...
- 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.
See the full eligibility criteria
- 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...
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Fuzhou, Fujian, China
- Dongguan, Guangdong, China
- Guangzhou, Guangdong, China
- Shenzhen, Guangdong, China
- Nanning, Guangxi, China
- Guiyang, Guizhou, China
- Wuhan, Hubei, China
- Changsha, Hunan, China
- Ganzhou, Jiangxi, China
- Chengdu, Sichuan, China
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fuzhou, Fujian, China; Dongguan, Guangdong, China; Guangzhou, Guangdong, China; Shenzhen, Guangdong, China; Nanning, Guangxi, China; Guiyang, Guizhou, China and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.