A Phase II Clinical Study to Evaluate HLX43 in Subjects With Advanced Non-small Cell Lung Cancer (NSCLC)

Part of paid clinical trials in Houston, Texas.

Sponsor
Shanghai Henlius Biotech
Study ID
NCT06907615
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • HLX43 DOSE 1 (2.0 mg/kg) — DRUG
    Dose 1; 2.0 mg/kg; 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 (2.5 mg/kg) — DRUG
    Dose 2; 2.5 mg/kg; 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.

Study Details

The study is being conducted to to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) in Patients with Advanced Non-small Cell Lung Cancer (NSCLC)

Key Dates

Start date
Jun 9, 2025
Status verified
Apr 2025
Primary completion
Apr 20, 2028
Completion
Jun 4, 2028

Study Design

Enrollment
243 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: HLX43 DOSE 1 (2.0 mg/kg)
    Patients with good tolerability and well controlled disease will receive the treatment once every 3 weeks (Q3W), Until disease progression, initiation of a new anti-tumor therapy, death, emergence of intolerable toxicity, or withdrawal of informed consent (whichever occurs first)
  • Experimental: HLX43 DOSE 2 (2.5 mg/kg)
    Patients with good tolerability and well controlled disease will receive the treatment once every 3 weeks (Q3W), Until disease progression, initiation of a new anti-tumor therapy, death, emergence of intolerable toxicity, or withdrawal of informed consent (whichever occurs first)

Primary Outcome Measure

ORR [ Time Frame: From date of the first dose of study drug until the date of death from any cause, assessed up to 24 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MD Anderson Cancer HospitalHoustonTexas77030-

Find similar trials in Houston, TX

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
MD Anderson Cancer Hospital· Houston, TX

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