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Clinical Study Protocol AN4005X0101 An Open-Label, Multicenter, Phase 1 Study of AN4005 in Patients With Advanced Tumors
Led by Adlai Nortye Biopharma Co., Ltd. · Updated on 2025-11-18
31
Participants Needed
7
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and pharmacokinetics of AN4005 in adults with advanced solid tumors or lymphoma for whom standard treatments are not available or suitable. This is a first-in-human, open-label, multicenter phase 1 trial designed to find the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) of AN4005. The study uses a dose escalation design to carefully assess safety and side effects in participants. Participants receive oral doses of AN4005 starting with a sentinel patient at 50 mg twice daily (BID). Subsequent cohorts of three patients receive increasing doses ranging from 100 mg BID up to 600 mg BID, with dose adjustments based on safety and dose-limiting toxicities observed during initial treatment cycles. A separate group will evaluate how a high-fat meal affects the drug's pharmacokinetics after a safe dose is identified. Dose escalation decisions are made jointly by investigators and sponsors. During the study, participants will be closely monitored for adverse events, serious adverse events, and dose-limiting toxicities over about one year. Laboratory tests, vital signs, physical exams, and organ function assessments will be performed. Researchers will measure drug concentrations in the blood to understand its behavior and will assess cancer response using established criteria. Follow-up includes safety evaluations up to 90 days after treatment ends.
CONDITIONS
Brief 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 informed consent
- Willing and able to follow all study procedures
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Life expectancy of at least 3 months
- Confirmed advanced solid tumors or relapsed/refractory lymphoma without standard treatment options
- Patients with or without measurable disease; measurable disease must be assessed by local investigator
- Provided tumor tissue samples or biopsies as required
- Left ventricular ejection fraction greater than 50%
- Adequate organ function including specific blood counts, liver enzymes, bilirubin levels, and kidney function
- Female participants must not be pregnant or breastfeeding and must follow contraceptive guidelines if of childbearing potential
- Male participants must agree to use contraception during treatment and for 90 days after
You will not qualify if you...
- Prior Grade 3 or higher immune-related adverse events from anti-PD-1/PD-L1 or other T-cell therapies
- Received systemic anti-cancer therapy or investigational agents within 4 weeks or 5 half-lives prior to study
- Less than 6 weeks since CAR-T infusion or presence of circulating CAR-T cells
- Recent palliative radiotherapy within 2 weeks without recovery
- Uncontrolled tumor-related pain
- Received live vaccines or certain COVID-19 vaccines within 30 days prior to study
- Participation in other investigational studies within 4 weeks prior to study
- History of allogenic tissue or solid organ transplant within 5 years
- Immunodeficiency or recent immunosuppressive therapy
- Recent or active other malignancies with specified exceptions
- Known severe hypersensitivity to study drug components
- Active autoimmune disease requiring recent systemic treatment
- History or presence of pneumonitis requiring steroids
- Active infection requiring systemic therapy within 2 weeks
- Significant cardiovascular impairment or arrhythmias
- Major surgery within 4 weeks without recovery
- Inability to take oral medications or gastrointestinal issues affecting drug absorption
- Psychiatric or substance abuse disorders affecting study compliance
- Pregnancy, breastfeeding, or plans to conceive during study
- Uncontrolled pleural, pericardial effusion, or ascites requiring frequent drainage
- Leptomeningeal disease or untreated spinal cord compression
- Recent use of oral or IV antibiotics (except prophylactic)
- Active tuberculosis
- Use of certain medications that cannot be stopped prior to study
- History of non-compliance or inability to consent
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 - Repeated 28-day cycles until disease progression or discontinuation
Participants receive escalating doses of the study drug AN4005, starting with a sentinel patient at 50 mg twice daily. Subsequent cohorts of 3 patients receive increasing doses up to 600 mg twice daily depending on safety and tolerability. Dose escalation decisions are based on safety data from each cohort.
Visits occur regularly during each treatment cycle for safety and dosing assessments
Duration - Approximately 3 months
Participants are monitored for approximately 90 days after the end of treatment to assess adverse events and safety outcomes.
Approximately 6 post-treatment visits for safety monitoring
Trial Site Locations
Total: 7 locations
1
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
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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
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5
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
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6
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China, 150081
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7
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China, 430000
Actively Recruiting
Research Team
K
Kirsten Lee
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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