A Study of HDM2020 in Patients With Advanced Sq-NSCLC (NCT07638891) | Clinical Trial Compass
RecruitingPhase 1
A Study of HDM2020 in Patients With Advanced Sq-NSCLC
China150 participantsStarted 2026-04-01
Plain-language summary
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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Participants must provide archival or fresh tumor tissue samples for prospective FGFR2b expression testing; only participants with FGFR2b high-expression are eligible for enrollment.
. Eastern Cooperative Oncology Group Performance Status (ECOG PS) is 0 or 1.
. The expected survival time is \>3 months.
. According to the RECIST v1.1, participants must have at least one measurable lesion.
. Laboratory test results during the screening period indicate that the participants have good organ function.
Exclusion criteria
. 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.
. Participants not recovered (recovered to ≤ Grade 1 or baseline) from relevant AEs resulting from prior treatments or other anti-cancer therapies.
. Participants with known active central nervous system (CNS) metastases.
. Participants with any of the following cardiovascular/cerebrovascular diseases/symptoms/indications: a) Mean resting QTc : ≥470 ms, ECG QTc measured three times within 10 min as the mean value; or those have a history or family history of congenital long QT syndrome; b) Any clinically significant abnormalities in resting ECG in rhythm, conduction, or morphology; c) Left ventricular ejection fraction (LVEF) \<50%; d) Participants with a history of myocardial contraction decreased and exhibited related symptoms within 6 months before study drug administration; e) Hypertension uncontrolled by drug therapy
. At screening, participants with active syphilis, immunodeficiency disease (HIV), active hepatitis B virus (HBV), or active hepatitis C virus (HCV).