A Phase II Study to Evaluate HLX43 in Subjects With Recurrent/Metastatic Nasopharyngeal Carcinoma Failed or Intolerance to Second-line Therapy

NCT06839066 | Recruiting Phase 2

• 1 other identifier: HLX43-NPC201
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 15

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.

Conditions

Nasopharyngeal Carcinoma (NPC)

Keywords

HLX43; Nasopharyngeal Carcinoma; anti-PD-L1 ADC

Outcome Measures

Primary Outcomes (2)

• ORR

  Objective response rate (ORR) (assessed by INV per RECIST v1.1)

  up to 24 week

• PFS

  Defined as the time (in months) from randomization to the first confirmed and documented progressive disease or death (whichever occurs first) as assessed by INV per RECIST v1.1.

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months

Secondary Outcomes (4)

• ORR

  up to 24 week

• PFS

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months

• OS

  From randomization to death from any cause (up to approximately 18 months)

• Incidence and severity of adverse events (AEs)

  time from the date of the first dose of study drug until 90 days after last dose, assessed up to 18 months

Study Arms (3)

HLX43 DOSE 1

EXPERIMENTAL

Patients with good tolerability and well controlled disease will receive the treatment once every 3 weeks (Q3W), until disease progression and loss of benifit, initiation of a new anti-tumor therapy, death, emergence of intolerable toxicity, or withdrawal of informed consent (whichever occurs first).

Drug: HLX43 DOSE 1

HLX43 DOSE 2

EXPERIMENTAL

Patients with good tolerability and well controlled disease will receive the treatment once every 3 weeks (Q3W), until disease progression and loss of benifit, initiation of a new anti-tumor therapy, death, emergence of intolerable toxicity, or withdrawal of informed consent (whichever occurs first).

Drug: HLX43 DOSE 2

HLX43 DOSE 3

EXPERIMENTAL

Patients with good tolerability and well controlled disease will receive the treatment once every 3 weeks (Q3W), until disease progression and loss of benifit, initiation of a new anti-tumor therapy, death, emergence of intolerable toxicity, or withdrawal of informed consent (whichever occurs first).

Drug: HLX43 DOSE 3

Interventions

HLX43 DOSE 1 DRUG

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.

HLX43 DOSE 1

HLX43 DOSE 2 DRUG

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.

HLX43 DOSE 2

HLX43 DOSE 3 DRUG

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.

HLX43 DOSE 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify 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 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.

Sponsors & Collaborators

• Shanghai Henlius Biotech: lead

Study Sites (15)

Fujian Cancer Hospital

Fuzhou, Fujian, China

RECRUITING

Dongguan People's Hospital

Dongguan, Guangdong, China

RECRUITING

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

RECRUITING

The First Affiliated Hospital of Guangdong Pharmaceutical University

Guangzhou, Guangdong, China

RECRUITING

Zhongshan City People's Hospital

Guangzhou, Guangdong, China

RECRUITING

Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen

Shenzhen, Guangdong, China

RECRUITING

Guangxi Medical University Cancer Hospital

Nanning, Guangxi, China

RECRUITING

Guizhou Medical University Cancer Hospital

Guiyang, Guizhou, China

RECRUITING

Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science & Technology

Wuhan, Hubei, China

RECRUITING

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, China

RECRUITING

Xiangya Hospital of Central South University

Changsha, Hunan, China

RECRUITING

First Affiliated Hospital of Gannan Medical University

Ganzhou, Jiangxi, China

RECRUITING

Sichuan Cancer Hospital

Chengdu, Sichuan, China

RECRUITING

West China Hospital of Sichuan University

Chengdu, Sichuan, China

RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Central Study Contacts

Wenhua Yu

CONTACT

+86 17638575068; Wenhua_Yu1@henlius.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2025
• First Posted: February 21, 2025
• Study Start: April 2, 2025
• Primary Completion (Estimated): November 22, 2026
• Study Completion (Estimated): November 22, 2027
• Last Updated: November 24, 2025

Record last verified: 2025-11

Locations

CN (15)