Actively Recruiting
A Phase 1 Study of HDM2017 in Advanced Solid Tumors
Led by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. · Updated on 2025-12-10
96
Participants Needed
1
Research Sites
84 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a phase I clinical study. All subjects are patients with advanced solid tumors. The purpose of this study is to to evaluate the safety, tolerability, pharmacokinetic (PK) characteristics, and preliminary antitumor efficacy of HDM2017 in patients with advanced malignant solid tumors.
CONDITIONS
Official Title
A Phase 1 Study of HDM2017 in Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to provide written informed consent
- Male or female aged 18 to 75 years
- Histologically or cytologically confirmed locally advanced unresectable or metastatic malignant solid tumors
- Failed, intolerant to, or no effective standard treatments available
- Able to provide archived tumor tissue during screening
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Life expectancy of at least 3 months
- Have at least one measurable lesion according to RECIST v1.1
- Adequate organ function
- Agree to use effective contraception during and for 7 months after last dose if of reproductive potential
- Willing and able to complete regular visits, treatments, lab tests, and other trial procedures
You will not qualify if you...
- Previously received ADC therapy with Top I inhibitors or drugs targeting CDH17
- Major surgery within 4 weeks before first dose
- Radiotherapy involving bone marrow or extensive radiotherapy within 4 weeks before first dose
- Local radiotherapy within 2 weeks before first dose
- Receiving continuous systemic corticosteroid therapy
- Received systemic antitumor or investigational drug therapy within 4 weeks or 5 half-lives (minimum 2 weeks) before first dose
- Other malignant tumors within past 5 years except locally cured tumors
- Unresolved adverse events from prior therapy worse than Grade 1 except alopecia or mild neuropathy
- Weight loss over 10% within 2 months or severe malnutrition
- History of gastrointestinal perforation, fistula, or extensive intestinal resection within 6 months
- Gastrointestinal obstruction or abscess within 3 months
- Gastrointestinal hemorrhage within 3 months or bleeding disorders
- Known active central nervous system metastasis
- Cardiovascular or cerebrovascular disorders or symptoms
- Active syphilis, HIV infection, active hepatitis B or C (except asymptomatic carriers)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking University Cancer Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
R
Ruichao Zeng
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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