Actively Recruiting
A Study of HDM2006 in Patients With Advanced Solid Tumor
Led by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. · Updated on 2026-01-30
48
Participants Needed
1
Research Sites
112 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 HDM2006 in patients with advanced solid tumors.
CONDITIONS
Official Title
A Study of HDM2006 in Patients With Advanced Solid Tumor
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understand and voluntarily sign informed consent.
- Male or female aged 18 years or older.
- For dose escalation: confirmed advanced or metastatic solid tumors with prior treatment failure or intolerance.
- For dose expansion: confirmed advanced or metastatic specific tumor types with prior treatment failure or intolerance, including head and neck squamous cell carcinoma, renal cell carcinoma, cervix carcinoma, and others.
- Ability and willingness to provide fresh or archival tumor tissue samples for biomarker analysis.
- ECOG performance status of 0 or 1.
- Expected survival time greater than 3 months.
- At least one evaluable lesion (dose escalation phase) or at least one measurable lesion (dose expansion phase) per RECIST v1.1.
- Adequate organ function based on laboratory tests without recent corrective medications.
- Women of childbearing potential must use effective contraception during and for 6 months after treatment; men must agree to contraception during and for 6 months after treatment.
- Willingness and ability to comply with study visits and procedures.
You will not qualify if you...
- Participation in another interventional clinical study unless in survival follow-up or observational study.
- Major surgery within 4 weeks before first dose (minor surgery allowed).
- Bone marrow or extensive radiotherapy within 28 days or local radiotherapy within 7 days before first dose.
- Previous treatment with HPK1 inhibitors.
- History of active malignancies within past 2 years, except certain cured local tumors.
- Unrecovered adverse events from prior treatments that pose safety risks.
- Unstable brain metastasis or CNS complications requiring emergency surgery.
- Epilepsy requiring treatment or history of psychotropic drug abuse without abstinence.
- Significant cardiac abnormalities including prolonged QTc, serious ECG changes, or low left ventricular ejection fraction.
- Active infections with HIV, hepatitis B or C (excluding asymptomatic carriers).
- Diagnosed interstitial lung disease or risk factors for lung toxicity.
- Active infections requiring antibiotics within 14 days before treatment.
- Active or history of autoimmune diseases requiring medication.
- History of primary immunodeficiency or active tuberculosis.
- Significant pleural, pericardial effusions or ascites poorly controlled.
- Gastrointestinal disorders impairing drug intake or absorption.
- History of solid organ transplant.
- Known allergy to study drug or analogues.
- Pregnant or breastfeeding women.
- Investigator judgment deeming participation unsuitable due to safety or compliance concerns.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, China, 200032
Actively Recruiting
Research Team
L
LingLuo
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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