CClinicalTrials.gg
RecruitingNCT07098052Updated Aug 1, 2025

A Study of HDM2020 in Patients With Advanced Solid Tumors

A Phase 1 interventional study of HDM2020 in Solid Tumor, sponsored by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-08-01.

Sponsored by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

The goal of this clinical trial is to learn if the study drug can work in advanced cancer patients. The main questions it aims to answer are:

  • Is the drug safe and tolerable ?
  • Does the drug exhibit antitumor activity ?

Participants will receive the study drug once every three weeks, and imaging-based efficacy assessments will be performed every six weeks.

Read the detailed description

Target population are patients with FGFR2-expressing solid tumors.

02

Conditions studied

  • Solid Tumor
03

In context

Lead sponsor

Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. is the lead sponsor of 49 studies on the registry; 38 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Participants who understand and voluntarily (or legal guardian) sign a written ICF approved by the Institutional Review Board or Independent Ethics Committee.
  2. Male or female participants aged ≥18 years.
  3. Participants must be patients with advanced or metastatic malignant solid tumors confirmed by histology or cytology, and have experienced sufficient standard treatment failure, or are intolerant to standard treatment, or have no effective standard treatment.
  4. Tumor tissue samples are required to be sent to the central laboratory for IHC testing.
  5. Eastern Cooperative Oncology Group Performance Status (ECOG PS) is 0 or 1.
  6. The expected survival time is >3 months.
  7. According to the RECIST v1.1, participants in Phase Ia must have at least one evaluable lesion, and participants in Phases Ib must have at least one measurable lesion.
  8. Laboratory test results during the screening period indicate that the participants have good organ function.
  9. 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.
  10. Participants with the willingness and ability to complete regular visits, treatment plans, laboratory tests, and other trial procedures.

Exclusion criteria

Exclusion Criteria:

  1. Participants with prior treatment with an ADC containing a topoisomerase I (Top I) inhibitor.
  2. 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.
  3. 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.
  4. Participants with active malignant tumors within the past 2 years.
  5. Participants not recovered (recovered to ≤ Grade 1 or baseline) from relevant AEs resulting from prior treatments or other anti-cancer therapies.
  6. Participants with known active central nervous system (CNS) metastases.
  7. 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
  8. At screening, participants with active syphilis, immunodeficiency disease (HIV), active hepatitis B virus (HBV), or active hepatitis C virus (HCV).
  9. 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.
  10. 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.
  11. Large amounts or symptomatic moderate amounts of pleural effusion, pericardial effusion, or ascites during the screening period, and still poorly controlled after treatments.
  12. Unstable thrombosis events requiring therapeutic intervention within 6 months before screening.
  13. A history of solid organ transplant.
  14. Known or suspected hypersensitivity to the study drug or its analogues.
  15. Pregnant and breastfeeding women.
  16. The investigator considers that the participant is not suitable to participate in this study.
  17. 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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    HDM 2020

    HDM2020

    Drug: HDM2020

Interventions

  • DrugHDM2020

    FGFR2b-ADC

06

What researchers measure

Primary outcomes

  1. Maximal tolerance dose (MTD) of HDM2020

    Maximum-tolerated dose (MTD) was defined as the dose level at which the estimated toxicity probability is closest to the target toxicity probability during the dose-escalation phase, within the DLT observation period (21 days) following the first administration of the IMP.

    Time frame: DLT will be evaluated on 21 days of observation period

  2. Incidence of Treatment-Emergent Adverse Events

    Incidence rates of adverse events (AE), serious adverse events (SAE)

    Time frame: Estimated 1 year

Secondary outcomes

  1. Time to peak (Tmax)

    Tmax of HDM2020, total antibody, and exatecan will be measured

    Time frame: Estimated 1 year

  2. Half-life time (t1/2)

    t1/2 of HDM2020, total antibody, and exatecan will be measured

    Time frame: Estimated 1 year

  3. Peak Plasma Concentration (Cmax)

    Cmax of HDM2020, total antibody, and exatecan will be measured

    Time frame: Estimated 1 year

  4. Area under the plasma concentration versus time curve (AUC)

    AUC of HDM2020, total antibody, and exatecan will be measured

    Time frame: Estimated 1 year

  5. Objective response rate (ORR)

    Objective response rate (ORR) assessed based on RECIST v1.1 criterion

    Time frame: Estimated 1 year

  6. Duration of response (DoR)

    Duration of response (DoR) assessed based on RECIST v1.1 criterion

    Time frame: Estimated 1 year

  7. Disease control rate (DCR)

    Disease control rate (DCR) assessed based on RECIST v1.1 criterion

    Time frame: Estimated 1 year

  8. Progression-free survival (PFS)

    Progression-free survival (PFS) assessed based on RECIST v1.1 criterion

    Time frame: Estimated 1 year

  9. Overall survival (OS)

    Overall survival (OS) of 6-months and 12-months

    Time frame: Estimated 1 year

Other outcomes

  1. Target expression levels

    Target expression levels and their correlation with antitumor activity.

    Time frame: Estimated 1 year

07

Study locations

1 of 1 sites recruiting
  • Sun Yat-sen University Cancer Center
    Guangzhou, Guangdong 510060, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 1, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07098052
Lead sponsor
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Aug 1, 2025
Start date
Aug 11, 2025 (estimated)
Primary completion
Sep 30, 2026 (estimated)
Completion
May 30, 2027 (estimated)
Last update
Aug 1, 2025

Study contacts

Ruihua Xu
Contact
rhuaxu@163.com
86-020-87343468

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion