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AN4005 for Advanced Solid Tumors and Lymphoma

This study is testing a new drug called AN4005 in people with advanced solid tumors or advanced lymphoma. It's the first time AN4005 is being given to humans, and the main goal is to find out how safe it is and what dose can be given without causing too many side effects. Researchers will also look at how your body handles the drug. You might be able to join if you are at least 18 years old, have a good general health status (ECOG Performance Status of 0 or 1), and are expected to live for at least 3 months. The study is considered successful if researchers can identify a safe and tolerable dose of AN4005.

Study design
This is an open-label, multi-center study, meaning both you and your doctors will know which treatment you are receiving. It aims to enroll 31 participants and uses a dose escalation design to find the safest and most effective dose.
What's involved
You will receive AN4005, starting at a low dose, which may be increased over time. Safety will be monitored through blood tests, vital signs, physical exams, and checking for any side effects for up to approximately one year.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be monitored for approximately 90 days after your last dose of AN4005.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04999384

First in Human, Dose Escalation Study of AN4005

Recruiting
PHASE1Ages 18+InterventionalTreatment
Adlai Nortye Biopharma Co., Ltd.
~31 participants
Updated 2025-11-18 on ClinicalTrials.gov
What's tested:AN4005-dose level 0AN4005-dose level 1AN4005-dose level 2AN4005-dose level 3AN4005-dose level 4AN4005-food effect

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with any adverse events (AEs), serious adverse events (SAEs), withdrawal due to AEs, dose interruptions and reductions
Measured over Up to approximately 1 year
+2 more outcomes measured

Conditions

Advanced Solid Tumor
Advanced Lymphoma

Explore related trials

LymphomaSolid Neoplasm

NCT04999384

Where you'd take part

This study runs at 7 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, Chinastudy coordinator listed

    Recruiting

  • Hackensack University Medical Center

    Hackensack, New Jerseystudy coordinator listed

    Recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, Chinastudy coordinator listed

    Recruiting

  • Montefiore Einstein Cancer Center

    The Bronx, New Yorkstudy coordinator listed

    Recruiting

  • Next Virginia

    Fairfax, Virginiastudy coordinator listed

    Recruiting

  • Prisma Health Institute for Translational Oncology Research

    Greenville, South Carolinastudy coordinator listed

    Recruiting

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei, Chinastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Kevin Dryer · STUDY_DIRECTOR · Adlai Nortye USA Inc

Who to contact

Kirsten Lee
[email protected]
614 362 2760
Email the study team

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Eligibility criteria

Inclusion

1\. Age ≥ 18 years at the time of informed consent and have provided signed informed consent for the trial.
Total abstinence: When this is in line with the preferred and usual lifestyle of the patient. (Periodic abstinence \[e.g., calendar, ovulation, symptothermal, post-ovulation methods\] and withdrawal are not acceptable methods of contraception.)
Female sterilization: When the female study patient has had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment.
Male partner sterilization (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate). For female study patients, the vasectomized male partner should be the sole partner for that patient.
Using a combination of any two of the following:
Placement of an intrauterine device (IUD) or intrauterine system (IUS), and
Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository.
Hormonal contraception methods (e.g., oral, injected, implanted).

What this trial measures

  • Number of participants with any adverse events (AEs), serious adverse events (SAEs), withdrawal due to AEs, dose interruptions and reductionsUp to approximately 1 year

    All AEs, SAEs and dose modifications will be collected

  • Number of participants with dose limiting toxicities (DLTs)Up to 28 days

    An event is considered to be a DLT if the event occurs within the first 28 days of treatment and meets the dose-limiting toxicity criteria, unless it can be clearly established that the event is unrelated to treatment

  • Number of participants with clinically significant changes in laboratory parameters, vital signs, physical examination and organ-specific parametersUp to approximately 1 year

    Blood and urine samples will be collected for analysis of lab parameters. Vital signs, physical examinations and organ-specific parameters will be collected at specified time points