Phase II Study of HLX43 for Advanced Non-Small Cell Lung Cancer (NSCLC)

Sponsor: Shanghai Henlius Biotech

Sponsor score: 0

ClinicalTrials ID:NCT06907615

Provider View

This clinical trial is testing a new drug, HLX43, to find the best dose and evaluate its safety and effectiveness in treating advanced non-small cell lung cancer (NSCLC).

Patient Parameters

Program Overview

The study aims to determine the most effective dose and assess the safety and effectiveness of HLX43, a new drug for patients with advanced non-small cell lung cancer (NSCLC). Participants will receive different doses of HLX43 through an IV to see how well it works and how safe it is.

Description

This is an open-label Phase II study, meaning both the researchers and participants know what treatment is being given. The study will test different doses of HLX43, a new drug designed to target and treat advanced non-small cell lung cancer (NSCLC). Participants will be randomly assigned to receive one of the doses through an intravenous (IV) infusion. The main goals are to find the best dose and to evaluate how safe and effective HLX43 is in treating this type of cancer.

Eligibility Criteria

Inclusion Criteria

  • Understand the study details and agree to participate by signing a consent form.
  • Be 18 years or older, male or female.
  • Have advanced non-small cell lung cancer (NSCLC) that cannot be treated with surgery or standard therapies.
  • Have tried standard treatments, including PD-(L)1 and platinum-based chemotherapy, without success.
  • Have at least one tumor that can be measured by scans.
  • Agree to provide a tumor sample for testing or undergo a biopsy.
  • Have completed previous cancer treatments and recovered from any side effects.
  • Have a good performance status, meaning you can carry out daily activities with little or no assistance.
  • Have a life expectancy of more than 3 months.
  • Have normal organ function as shown by lab tests.
  • Agree to use effective birth control during the study and for 6 months after the last dose if you are of childbearing potential.

Exclusion Criteria

  • Have a type of lung cancer other than non-small cell lung cancer.
  • Have previously received treatments targeting topoisomerase I.
  • Have tumors invading major blood vessels or vital organs, or at risk of causing serious complications.
  • Have had major radiation therapy within 3 months before starting the study.
  • Have had another cancer within the last 2 years, except for certain early-stage cancers.
  • Have had severe side effects from previous immunotherapy.
  • Have uncontrolled fluid buildup around the lungs, heart, or abdomen.
  • Have untreated or active brain metastases.
  • Have significant lung problems or diseases.
  • Have serious heart or blood vessel conditions.
  • Have active infections requiring treatment.
  • Have used certain medications that affect the liver or immune system recently.
  • Have autoimmune diseases, except for controlled hypothyroidism or diabetes.
  • Have received a live vaccine recently.
  • Have severe allergies to proteins or antibodies.
  • Have active tuberculosis or a history of immune system problems.
  • Have active hepatitis B or C infections.
  • Are pregnant or breastfeeding.
  • Have any other conditions that make participation unsafe.

Locations

FACILITYZIPCITYSTATE
MD Anderson Cancer Hospital77030HoustonTexas

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