Actively Recruiting
A Study of HDM2024 in Participants With Advanced Solid Tumors
Led by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. · Updated on 2026-04-20
63
Participants Needed
1
Research Sites
141 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 HDM2024 in Participants With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants aged 18 to 75 years (inclusive).
- Male or female participants who voluntarily consent to participate after being fully informed.
- Participants with histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumors who have progressed after standard therapy, are intolerant to standard therapy, or have no effective standard care available.
- Participants able to provide fresh or archival tumor tissue during screening for biomarker testing including EGFR and HER3.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
- Life expectancy of 3 months or more.
- At least one measurable lesion according to RECIST v1.1.
- Participants with good organ function based on screening laboratory tests.
- Fertile participants agree to use effective contraception during the study and after, and must have a negative serum human chorionic gonadotropin (HCG) test within 7 days before dosing.
- Willing and able to complete regular visits, treatment plans, laboratory tests, and other study procedures.
You will not qualify if you...
- Previous treatment with ADC containing exatecan or an ADC primarily targeting EGFR and/or HER3.
- 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; stable low-dose corticosteroids allowed.
- Anti-tumor treatments within 4 weeks before first dose or within 5 half-lives of last anticancer therapy.
- Use of Traditional Chinese medicines with approved anticancer indications within 2 weeks before first dose.
- Other malignant tumors within past 5 years except locally cured tumors.
- Unresolved adverse events from previous treatments except alopecia and less than or equal to Grade 2 sensory neuropathy.
- Known weight loss greater than 10% within 2 months before first dose or signs of severe malnutrition.
- Serious complications or medical histories involving important organs.
- Active central nervous system metastasis.
- Any cardiovascular or cerebrovascular disorders, symptoms, or manifestations.
- Active syphilis, history of HIV infection, active hepatitis B or C (except asymptomatic carriers).
- History of interstitial pneumonia or moderate to severe lung disorders affecting lung function.
- Severe infection during screening.
- Other diseases affecting study drug efficacy or safety.
- Uncontrolled pericardial effusion, pleural effusion, or significant ascites during screening.
- Unstable thrombotic events requiring treatment within 6 months before screening (excluding thrombosis related to infusion devices).
- Live vaccine within 30 days before first dose or planned during study.
- Use of strong CYP3A4 inhibitors or inducers within 1 week before dosing or expected long-term use during and 30 days after study.
- History of solid organ transplant.
- Known or suspected severe allergy to study drug components or analogues.
- Pregnant or lactating women.
- Deemed unsuitable for study by investigator (e.g., poor compliance).
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai East Hospital
Shanghai, Shanghai Municipality, China, 200123
Actively Recruiting
Research Team
Z
Zhou Caicun
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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