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

Official title

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

Overview

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.

Interventions

• Drug TQB2102 for injection
  HER2 dual-antibody-drug Conjugate (ADC).
• Drug TQB2102 for injection combined with Benmelstobart injection
  TQB2102 for injection is a HER2 dual-antibody-drug Conjugate (ADC); Benmelstobart injection is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1).

Primary outcome measures

• Overall Response Rate (ORR) [Time frame: Baseline up to 8 months]

Secondary outcome measures (6)

• Duration Of Remission (DOR) [Time frame: Baseline up to 8 months]
• Progression-Free Survival (PFS) [Time frame: Baseline up to 8 months]
• Overall Survival (OS) [Time frame: Baseline up to 18 months]
• Frequency of adverse event (AE) [Time frame: From the date of signing the informed consent to 28 days after the last dosing or a new anti-tumor treatment, whichever comes first.]
• Severity of adverse event (AE) [Time frame: From the date of signing the informed consent to 28 days after the last dosing or a new anti-tumor treatment, whichever comes first.]
• Anti-drug antibody (ADA) [Time frame: Before infusion on Cycle1 Day1, Cycle2 Day1, Cycle 4 Day1, Cycle7 Day1, Cycle12 Day1 (each cycle is 21 days), 90 days after the end of the last infusion (each cycle is 21 days).]

Eligibility criteria

Inclusion criteria

• Subjects voluntarily participate in this study and sign informed consent;
• Between the ages of 18-75 years (subject to the date of signing the informed consent); Eastern cooperative oncology group (ECOG) score 0-1; estimated survival time ≥3 months;
• Patients with locally advanced, metastatic, or recurrent non-small cell lung cancer that is cytologically or histologically proven to be inoperable and cannot be treated with radical concurrent chemoradiotherapy;
• Previous standard treatments failed；
• At least one measurable lesion (based on Response Evaluation Criteria In Solid Tumors 1.1);
• Female participants of childbearing age should agree to use contraception during the study period and for 6 months after the end of the study; Have a negative serum pregnancy test within 7 days prior to study enrollment and must be a non-lactating subject; Male participants should agree that contraception must be used during the study period and for 6 months after the end of the study period.

Exclusion criteria

• Has diagnosed and/or treated additional malignancy within 3 years prior to take medication;
• Adverse effects due to any prior treatment have not been restored to CommonTerminology Criteria for Adverse Events (CTCAE) 5.0 ≤ level 1 (Excluding hair loss);
• Major surgical treatment, incision biopsy, or significant traumatic injury were received within 28 days prior to study treatment,and minor traumatic surgery (biopsy, bronchoscopy, and chest drainage) within 7 days;
• Long-term unhealed wounds or fractures;
• History of interstitial lung disease, radiation pneumonia, and immune-related pneumonia treated with steroids in the past, or active non-infectious pneumonia with interstitial changes such as interstitial lung disease, radiation pneumonia, and immune-related pneumonia in the screening period, active pulmonary tuberculosis, pneumoconiosis, or other types of pneumonia ≥ grade 2, or severe impairment of lung function confirmed by pulmonary function examination;
• Arterial/deep vein thrombosis events occurred within 6 months prior to treatment, such as cerebrovascular accident, deep vein thrombosis and pulmonary embolism;
• Patients who have a history of psychotropic substance abuse and are unable to abstain or have mental disorders;
• Patients with any severe and/or uncontrolled disease;
• Any anticancer therapy or any other investigational drug treatment within 28 days or 5 half-lives prior to the first dosing of this study;
• Within 1 week prior to the first administration of this study, the Chinese patent drugs with anti-tumor indications clearly stated in the National MedicalProducts Administration approved drug instructions were treated;
• Local focal palliative radiotherapy was received within 2 weeks before the first dose;
• Patients with serous effusion requiring repeated drainage to relieve clinical symptoms or who have received serous effusion drainage for therapeutic purposes within 2 weeks prior to treatment;
• There is symptomatic or progressive exacerbation of central nervous system metastatic or cancerous meningitis with diffuse spread. Subjects with a history of brain metastases may be considered for inclusion if they are clinically stable;
• Severe bone injury caused by tumor bone metastasis, including pathological fractures and spinal cord compression that occurred within 6 months or are likely to occur in the near future;
• Pain associated with uncontrolled bone metastases;
• Allergic to humanized monoclonal antibody products;
• Allergic to any investigational drug or to any ingredient or excipient in the drug;
• Persons who have received live attenuated vaccine within 4 weeks prior to treatment;
• Subjects who, in the investigator's judgment, have concomitant diseases that seriously endanger the safety of subjects or interfere with the completion of the study, or who are deemed unsuitable for enrollment for other reasons.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 25 centers

• Fujian Cancer Hospital — Fuzhou
• Foshan First People's Hospital — Foshan
• Sun Yat-sen University Cancer Center — Guangzhou
• Jiangmen Central Hospital — Jiangmen
• The Second People's Hospital of Shenzhen — Shenzhen
• Guangxi Medical University Cancer Hospital — Nanning
• The Second Affiliated Hospital of Zunyi Medical University — Zunyi
• Harbin Medical University cancer hospital — Harbin
• … and 17 more centers

Identifiers

NCT: NCT06496490 · TQB2102-II-03

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗