Actively Recruiting
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic (PK) Characteristics, and Preliminary Antitumor Efficacy of HDM2017 in Participants With Advanced Malignant Solid Tumors
Led by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. · Updated on 2025-12-10
96
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating HDM2017 in patients with advanced malignant solid tumors in this phase I clinical study. The study aims to assess the safety, tolerability, how the drug moves through the body (pharmacokinetics), and early signs of antitumor activity in adults with advanced solid tumors who have limited or no effective treatment options. Participants will receive increasing doses of HDM2017 through intravenous infusion. After determining the maximum tolerated dose, at least two dose levels will be expanded to find the recommended dose for future studies. This dose escalation and expansion approach helps understand how best to use HDM2017 for these tumors. During the study, participants will undergo regular visits with treatment, lab tests, and other trial procedures. Researchers will monitor adverse events, drug levels in the blood, immune responses, tumor responses, and survival outcomes up to 30 days after the last dose. The study is designed to last until July 2027 for adults aged 18 to 75 with good performance status and measurable tumors.
CONDITIONS
Brief Title
A Phase 1 Study of HDM2017 in Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be able and willing to provide written informed consent.
- Male or female participants aged 18 to 75 years.
- Histologically or cytologically confirmed locally advanced unresectable or metastatic malignant solid tumors.
- Failed adequate standard of care, intolerant to standard care, or have no effective standard treatment options.
- Able to provide archived tumor tissue during screening.
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
- Life expectancy of at least 3 months.
- At least one measurable lesion according to RECIST v1.1.
- Adequate organ function.
- Subjects of reproductive potential must agree to use effective contraception during and for 7 months after last dose.
- Willing and able to complete regular visits, treatment plans, laboratory tests, and other trial procedures.
You will not qualify if you...
- Prior ADC therapy containing Top I inhibitors or other drug therapy 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.
- Continuous systemic corticosteroid therapy.
- 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 above Grade 1 except alopecia and mild sensory neuropathy.
- Known weight loss over 10% within 2 months or severe malnutrition.
- History of gastrointestinal perforation, fistula, extensive intestinal resection within 6 months.
- Complete or incomplete gastrointestinal obstruction or intra-abdominal abscess within 3 months.
- History of gastrointestinal hemorrhage within 3 months or known 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration varies by dose escalation and expansion phases
Participants receive escalating doses of HDM2017 through intravenous infusion to evaluate safety, tolerability, and preliminary antitumor efficacy.
Multiple visits for dosing and assessments during treatment
Duration - 30 days after the last dose of HDM2017
Participants are monitored for safety and response for 30 days after the last dose of HDM2017.
Approximately 1 to 2 visits during follow-up
Trial Site Locations
Total: 1 location
1
Peking University Cancer Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
R
Ruichao Zeng
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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