Actively Recruiting
A Study of HDM2012 in Patients With Advanced Solid Tumor
Led by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. · Updated on 2025-08-08
129
Participants Needed
1
Research Sites
147 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a first-in-human (FIH) study to evaluate the safety and preliminary efficacy of experimental drug HDM2012 in patients with advanced solid tumors.
CONDITIONS
Official Title
A Study of HDM2012 in Patients With Advanced Solid Tumor
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants or their legal guardians must voluntarily sign an informed consent form approved by the ethics board.
- Male or female participants aged 18 to 75 years.
- For dose escalation: confirmed advanced or metastatic solid tumors previously treated with no standard options remaining.
- For dose expansion and backfill cohorts: confirmed advanced or metastatic gastric or colorectal cancer.
- Tumor tissue samples must be sent for immunohistochemical testing.
- ECOG performance status of 0 or 1.
- Expected survival longer than 3 months.
- At least one evaluable or measurable tumor lesion per RECIST v1.1 criteria.
- Adequate organ function as shown by lab tests without recent growth factor or corrective treatments.
- Women and men of reproductive potential must agree to use highly effective birth control methods during treatment and for specified periods after.
- Willing and able to complete all study visits and procedures.
You will not qualify if you...
- Prior treatment with antibody-drug conjugates containing topoisomerase I inhibitors.
- Major surgery within 4 weeks before first dose, except minor procedures.
- Radiation to bone marrow or extensive radiation within 4 weeks before first dose; local radiotherapy within 2 weeks before first dose.
- Continuous systemic corticosteroids over 10 mg/day prednisone equivalent within 2 weeks before first dose.
- Other systemic anti-tumor therapies within 4 weeks or 5 half-lives before first dose unless justified.
- Active malignancies within the past 2 years except studied cancer and certain cured localized tumors.
- Unresolved treatment-related adverse events above grade 1, except some mild conditions.
- Active central nervous system metastases unless stable and treated.
- Cardiovascular or cerebrovascular diseases or conditions.
- Active infections like syphilis, HIV, or active hepatitis except asymptomatic chronic carriers.
- History or evidence of certain lung diseases or pneumonia.
- Intestinal obstruction or risk of it.
- Other diseases affecting study drug safety or efficacy.
- Large or poorly controlled pleural, pericardial effusion, or ascites.
- Unstable thrombotic events within 6 months.
- Previous solid organ transplant.
- Known allergy to study drug components.
- Pregnant or breastfeeding women.
- Investigator judgment deeming participant unsuitable.
- Recent use or anticipated need for strong or moderate CYP3A4 inhibitors or inducers interfering with study drug.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Zhongshan Hospital, Fudan University
Shanghai, China
Actively Recruiting
Research Team
H
Hua Liu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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