Actively Recruiting
First in Human, Dose Escalation Study of AN4005
Led by Adlai Nortye Biopharma Co., Ltd. · Updated on 2025-11-18
31
Participants Needed
7
Research Sites
270 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Open-label, multicenter, phase 1 study to investigate the safety, tolerability, and PK of AN4005 in patients with advanced tumors. This study is a first-in-human, dose escalation study with the objective to establish the MTD and/or RP2D of AN4005. Except for Dose Level 0 (50 mg), a traditional "3 + 3 design" will be utilized for dose finding with dose escalation and/or de-escalation as appropriate.
CONDITIONS
Official Title
First in Human, Dose Escalation Study of AN4005
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at the time of consent
- Willing and able to follow all study procedures
- ECOG Performance Status of 0 or 1
- Life expectancy of at least 3 months
- Histologically or cytologically confirmed advanced solid tumors that are metastatic or unresectable, or relapsed/refractory lymphoma
- No available or suitable standard therapy
- Patients with or without measurable disease are eligible
- Provided archival or new tumor tissue samples
- Left ventricular ejection fraction greater than 50%
- Adequate organ function including specified blood counts, liver enzymes, bilirubin, and kidney function
- Female participants must not be pregnant or breastfeeding and either not of childbearing potential or agree to contraception during treatment and 90 days after
- Male participants agree to use contraception during treatment and for 90 days after
You will not qualify if you...
- Prior treatment stopped due to severe immune-related adverse events
- Received systemic anti-cancer or investigational therapy within 4 weeks
- Less than 6 weeks since CAR-T infusion or residual circulating CAR-T cells present
- Received palliative radiotherapy within 2 weeks
- Uncontrolled tumor-related pain
- Received live vaccines within 30 days before study drug
- Currently in another investigational study within 4 weeks
- Allogenic tissue or solid organ transplant within 5 years
- Immunodeficiency or recent immunosuppressive therapy
- History of other primary malignancy within 2 years except certain treated cancers
- Severe hypersensitivity to study drug components
- Active autoimmune disease requiring systemic treatment in past 2 years
- History or current pneumonitis requiring steroids
- Active infection needing systemic therapy within 2 weeks
- Significant cardiovascular impairment or recent major cardiac events
- Major surgery within 4 weeks
- Inability to take oral medication or uncontrolled gastrointestinal conditions
- Conditions interfering with study participation or results
- Psychiatric or substance abuse disorders affecting cooperation
- Pregnant, breastfeeding, or expecting to conceive/father children
- Uncontrolled effusions requiring frequent drainage
- Leptomeningeal disease
- Untreated or unstable spinal cord compression
- Recent oral or IV antibiotics (except prophylactic)
- Active tuberculosis
- Treatment with certain drugs affecting metabolism that cannot be stopped
- History of non-compliance to medical treatment or inability to consent
AI-Screening
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Trial Site Locations
Total: 7 locations
1
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
2
Montefiore Einstein Cancer Center
The Bronx, New York, United States, 10461
Actively Recruiting
3
Prisma Health Institute for Translational Oncology Research
Greenville, South Carolina, United States, 29605
Actively Recruiting
4
Next Virginia
Fairfax, Virginia, United States, 22031
Actively Recruiting
5
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
6
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China, 150081
Actively Recruiting
7
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China, 430000
Actively Recruiting
Research Team
K
Kirsten Lee
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
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