Squamous Non-small Cell Lung Cancer(NSCLC)Phase 1NCT07638891
A Study of HDM2020 in Patients With Advanced Sq-NSCLC
A Phase 1 study testing HDM2020 (FGFR2b-ADC) in people with Squamous Non-small Cell Lung Cancer(NSCLC), run by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. at 1 site in China.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Squamous Non-small Cell Lung Cancer(NSCLC)
- What is being tested?
- HDM2020 (FGFR2b-ADC)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2026to 3 Nov 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) is 0 or 1.
- The expected survival time is >3 months.
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- 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.
- Women of childbearing potential (WOCBP) must be willing to use two appropriate barrier methods of contraception from the time of signing informed consent until 7 months after the last dose of study treatment or use barrier contraception plus hormonal contraception to prevent pregnancy, or abstain from heterosexual intercourse throughout the study period; male participants must agree to take adequate contraceptive measures from the first dose of study treatment until 7 months after the last dose of study treatment.
- Participants with the willingness and ability to complete regular visits, treatment plans, laboratory tests, and other trial procedures.
Who cannot join
- 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.
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- 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).
- Presence of interstitial pneumonia, history of idiopathic pulmonary fibrosis, history of organising pneumonia, history of drug-induced pneumonia, history of idiopathic pneumonia, or evidence of active pneumonia found on chest computed tomography (CT) scan during the screening period; prior use of steroid pulse therapy due to pneumonia; Moderate or severe chronic obstructive pulmonary disease (COPD); Pulmonary malignant lymphangitis.
- Other diseases that may affect the efficacy and safety of the study drug, including but not limited to: a) Active infection requiring antibiotic therapy occurring within 2 weeks prior to the administration of study drug; b) Active autoimmune diseases or a history of autoimmune diseases; c) History of primary immunodeficiency; d) Active pulmonary tuberculosis; e) Participants who have had a clinically significant haemorrhage or significant haemorrhagic diathesis within 4 weeks before signing the informed consent; f) Any severe or uncontrolled systemic disease.
- Large amounts or symptomatic moderate amounts of pleural effusion, pericardial effusion, or ascites during the screening period, and still poorly controlled after treatments.
- Unstable thrombosis events requiring therapeutic intervention within 6 months before screening.
- A history of solid organ transplant.
- Known or suspected hypersensitivity to the study drug or its analogues.
- Pregnant and breastfeeding women.
- The investigator considers that the participant is not suitable to participate in this study.
- Participants who have received strong CYP3A4 inhibitors within 1 week before dosing, or are expected to require long-term use of strong CYP3A4 inhibitors during the study intervention period and within 30 days after the last dose.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080
Binchao Wang, 86-020-81884713 -80521 ext. 13059161908, wangbinchao@gdph.org.cn
About this study
Official title: A Phase Ib Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of HDM2020 in Patients With Advanced Squamous Non-small Cell Lung Cancer
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.
Read the detailed description
Target population are patients with FGFR2-expressing late line squamous non-small cell lung cancer(NSCLC) tumors.
- Being tested
- HDM2020 (FGFR2b-ADC)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HDM2020 (FGFR2b-ADC)Drug
This Phase I study only focuses on squamous non-small cell lung cancer.
| Study group | Role | What they receive |
|---|---|---|
| HDM 2020 | Experimental | HDM2020 Intravenous administration Receives: Drug: HDM2020 (FGFR2b-ADC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events
Incidence rates of adverse events (AE), serious adverse events (SAE)
Measured: Up to 2 years
Objective response rate (ORR)
Objective response rate (ORR) assessed based on RECIST v1.1 criterion
Measured: Up to 2 years
Disease control rate (DCR)
Disease control rate (DCR) assessed based on RECIST v1.1 criterion
Measured: Up to 2 years
Duration of response (DoR)
Duration of response (DoR) assessed based on RECIST v1.1 criterion
Measured: Up to 2 years
Progression-free survival (PFS)
Progression-free survival (PFS) assessed based on RECIST v1.1 criterion
Measured: Up to 2 years
Overall survival (OS)
Overall survival (OS) of 6-months and 12-months
Measured: Up to 2 years
Recommended Phase 2 Dose (RP2D)
Recommended Phase 2 Dose
Measured: Up to 2 years
Secondary outcomes (4)
Time to peak (Tmax)
Tmax of HDM2020, total antibody, and exatecan will be measured
Measured: Up to 2 years
Half-life time (t1/2)
t1/2 of HDM2020, total antibody, and exatecan will be measured
Measured: Up to 2 years
Peak Plasma Concentration (Cmax)
Cmax of HDM2020, total antibody, and exatecan will be measured
Measured: Up to 2 years
Area under the plasma concentration versus time curve (AUC)
AUC of HDM2020, total antibody, and exatecan will be measured
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start1 Apr 2026
- Primary completion31 Jan 2027 (estimated)
- Study completion3 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Non-small Cell Lung Cancer(NSCLC)Studies of the same condition, open and under way.
- More trials run by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07638891
- Sponsor's protocol ID
- HDM2020-103
- Status last verified
- Jun 2026
- First submitted
- 5 Jun 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of HDM2020 in Patients With Advanced Squamous Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07638891
- Acronym / sponsor ID
- HDM2020-103
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 3 Nov 2027 (estimated)
- First posted
- 10 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Target population are patients with FGFR2-expressing late line squamous non-small cell lung cancer(NSCLC) tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HDM 2020 | Experimental | Drug: HDM2020 (FGFR2b-ADC)HDM2020 Intravenous administration |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) is 0 or 1.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HDM2020 (FGFR2b-ADC)This Phase I study only focuses on squamous non-small cell lung cancer. | Drug | HDM 2020 |
Primary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: Up to 2 years
Incidence rates of adverse events (AE), serious adverse events (SAE)
Objective response rate (ORR)
Time frame: Up to 2 years
Objective response rate (ORR) assessed based on RECIST v1.1 criterion
Disease control rate (DCR)
Time frame: Up to 2 years
Disease control rate (DCR) assessed based on RECIST v1.1 criterion
Duration of response (DoR)
Time frame: Up to 2 years
Duration of response (DoR) assessed based on RECIST v1.1 criterion
Progression-free survival (PFS)
Time frame: Up to 2 years
Progression-free survival (PFS) assessed based on RECIST v1.1 criterion
Overall survival (OS)
Time frame: Up to 2 years
Overall survival (OS) of 6-months and 12-months
Recommended Phase 2 Dose (RP2D)
Time frame: Up to 2 years
Recommended Phase 2 Dose
4 secondary outcomes
Time to peak (Tmax)
Time frame: Up to 2 years
Half-life time (t1/2)
Time frame: Up to 2 years
Peak Plasma Concentration (Cmax)
Time frame: Up to 2 years
Area under the plasma concentration versus time curve (AUC)
Time frame: Up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HDM2020 (FGFR2b-ADC) in people with Squamous Non-small Cell Lung Cancer(NSCLC), run by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Binchao Wang (86-020-81884713 -80521 ext. 13059161908, wangbinchao@gdph.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (time frame: Up to 2 years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.