Actively Recruiting
A Study of HDM2020 in Patients With Advanced Solid Tumors
Led by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. · Updated on 2025-08-01
60
Participants Needed
1
Research Sites
93 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of HDM2020 in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant or legal guardian understands and signs informed consent
- Male or female aged 18 years or older
- Diagnosed with advanced or metastatic malignant solid tumors confirmed by histology or cytology
- Experienced failure of standard treatment, intolerance to standard treatment, or no effective standard treatment available
- Tumor tissue samples available for testing
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
- Expected survival time greater than 3 months
- At least one evaluable lesion for Phase Ia or one measurable lesion for Phase Ib according to RECIST v1.1
- Good organ function based on laboratory tests during screening
- Women of childbearing potential agree to use two barrier methods of contraception or barrier plus hormonal contraception, or abstain from heterosexual intercourse during study and for 7 months after last dose; males agree to adequate contraception during study and for 7 months after last dose
- Willingness and ability to complete regular visits, treatment plans, lab tests, and other trial procedures
You will not qualify if you...
- Prior treatment with antibody-drug conjugate containing topoisomerase I inhibitor
- Active or chronic corneal disorders or other significant eye diseases
- Major surgery within 4 weeks before first dose
- Bone marrow or extensive radiotherapy within 4 weeks before first dose
- Local radiotherapy within 2 weeks before first dose
- Continuous systemic corticosteroids or systemic anti-tumor treatments within 4 weeks before first dose
- Active malignant tumors within past 2 years
- Not recovered from adverse events related to prior treatments
- Known active central nervous system metastases
- Certain cardiovascular or cerebrovascular conditions including prolonged QTc, abnormal ECG, low left ventricular ejection fraction, recent myocardial issues, or uncontrolled hypertension
- Active infections including syphilis, HIV, hepatitis B or C at screening
- Lung diseases including interstitial pneumonia, pulmonary fibrosis, pneumonia, COPD, or pulmonary malignant lymphangitis
- Other diseases affecting safety or efficacy including active infection requiring antibiotics, autoimmune diseases, immunodeficiency, active tuberculosis, recent significant hemorrhage, or severe systemic disease
- Large or symptomatic pleural, pericardial effusion, or ascites not well controlled
- Unstable thrombosis requiring intervention within 6 months
- History of solid organ transplant
- Known or suspected hypersensitivity to study drug or analogues
- Pregnant or breastfeeding women
- Investigator's judgment deeming participant unsuitable
- Use of strong CYP3A4 inhibitors within 1 week before dosing or expected need for long-term use during and 30 days after study drug administration
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
R
Ruihua Xu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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