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RecruitingNCT06496490

A Clinical Trial of TQB2102 for Injection in Non-small Cell Lung Cancer With HER2 Gene Abnormality

A Phase 2 Clinical Trial of TQB2102 for Injection in Locally Advanced or Metastatic Non-small Cell Lung Cancer With HER2 Gene Abnormality to Evaluate the Efficacy and Safety

Status
Recruiting
Phase
Phase 2
Study type
Interventional
Enrollment
270 (estimated)
Sponsor
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. · Industry
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

Summary

TQB2102 is an antibody-drug conjugate comprised of a humanised antibody against Human Epidermal Growth Factor Receptor 2 (HER2), a enzyme-cleavable linker, and a topoisomerase I inhibitor payload, which combine the ability of antibodies to specifically target tumour cells with the highly potent killing activity of drugs with payloads too toxic for systemic administration. This is a Phase 2 study to evaluate the efficacy,and safety of TQB2102 for injection in locally advanced or metastatic non-small cell lung cancer with HER2 gene abnormality.

Conditions

Interventions

TypeNameDescription
DRUGTQB2102 for injectionHER2 dual-antibody-drug Conjugate (ADC).
DRUGTQB2102 for injection combined with Benmelstobart injectionTQB2102 for injection is a HER2 dual-antibody-drug Conjugate (ADC); Benmelstobart injection is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1).

Timeline

Start date
2024-08-06
Primary completion
2026-06-01
Completion
2026-12-01
First posted
2024-07-11
Last updated
2025-11-20

Locations

25 sites across 1 country: China

Source: ClinicalTrials.gov record NCT06496490. Inclusion in this directory is not an endorsement.