A Study of HDM2020 in Patients With Advanced Sq-NSCLC
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
About this trial
The goal of this clinical trial is to learn if the study drug can treat in advanced squamous non-small cell lung cancer(NSCLC) patients. The main questions it aims to answer are:
Is the drug safe and tolerable? Does the drug show antitumor activity? Participants will receive the study drug once(D1) or twice(D1.D8) every three weeks, and undergo imaging-based efficacy assessments every six weeks.
Eligibility criteria
Qualifiers
Participants who are able to understand and voluntarily sign a written Informed Consent Form (ICF) approved by an Institutional Review Board (IRB) or Independent Ethics Committee (IEC), or their legally authorized representative (LAR), if applicable.
Male or female participants aged 18 to 75 years.
Participants must have histologically or cytologically confirmed locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) squamous non-small cell lung cancer (sqNSCLC) that is not amenable to curative surgical resection, staged according to the 8th edition of the Union for International Cancer Control (UICC) and American Joint Committee on Cancer (AJCC) TNM staging system for lung cancer, and must have experienced treatment failure or intolerance to adequate prior standard-of-care therapy, including platinum-based chemotherapy and anti-PD-1/PD-L1 therapy. The anti-PD-1/PD-L1 therapy may have been administered as combination therapy or sequential therapy, or as neoadjuvant and/or adjuvant therapy (if a participant received neoadjuvant or adjuvant therapy and experienced relapse or progression during treatment or within 6 months of treatment completion, such therapy will be considered as failure of first-line standard-of-care treatment).
Participants must provide archival or fresh tumor tissue samples for prospective FGFR2b expression testing; only participants with FGFR2b high-expression are eligible for enrollment.
Disqualifiers
Participants with prior treatment with an ADC containing a topoisomerase I (Top I) inhibitor.
Participants with active or chronic corneal disorders, history of corneal transplant, keratitis, keratoconjunctivitis, keratopathy, corneal abrasion, inflammation or ulcer, other active eye disorders, and any clinically significant corneal disorders.
Participants underwent major surgery within 4 weeks before the first dose; Participants received bone marrow or extensive radiotherapy within 4 weeks before the first dose; received local radiotherapy within 2 weeks before the first dose of the study drug; Participants continuously received systemic corticosteroids; Participants received standard chemotherapy, biological therapy, immunotherapies, any investigational medicinal product (IMP) and other systemic anti-tumor treatments within 4 weeks before the first dose.
Participants with active malignant tumors within the past 5 years.
Trial design
Treatments tested in this trial
- HDM2020 (FGFR2b-ADC)
Treatment groups
150 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov