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Clinical Trials List

Protocol NumberAN4005X0101
Active

2024-11-01 - 2028-09-30

Phase I

Not yet recruiting5

Recruiting2

ICD-10D49.0

Neoplasm of unspecified behavior of digestive system

ICD-9239.0

Neoplasm of unspecified nature of digestive system

An Open-Label, Multicenter, Phase 1 Study of AN4005 in Patients with Advanced Tumors

  • Trial Applicant

    IQVIA RDS Taiwan Ltd.

  • Sponsor

    Adlai Nortye USA Inc.

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Jih-Hsiang Lee Division of Hematology & Oncology
National Taiwan University Hospital Hsin-Chu Branch

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Chia-Chi Lin Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Chia-Lun Chang Division of Hematology & Oncology
Taipei WanFang Hospital (Managed by Taipei Medical Univeristy)

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Mu-Hsin Chang Division of Hematology & Oncology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Yu-Li Su Division of Hematology & Oncology
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 曹朝榮 Division of Hematology & Oncology
Chi Mei Hospital, Liouying

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Wei-Hong Cheng
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Advanced Tumors

Objectives

To evaluate the safety and tolerability of AN4005 in subjects with advanced tumors and determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) • To further evaluate the safety and tolerability of AN4005 in selected indications at two dose levels in the expansion phase

Test Drug

tablets

Active Ingredient

AN4005

Dosage Form

116

Dosage

50mg/200mg

Endpoints

To characterize the pharmacokinetic (PK) profile of AN4005
• To assess the effect of food on the bioavailability of AN4005
• To evaluate the preliminary efficacy of AN4005 as assessed by: objective response rate (ORR), progression-free survival (PFS), disease control rate (DCR), and duration of response (DOR) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
• To evaluate the preliminary efficacy of AN4005 as assessed by: ORR, PFS, DCR, complete remission rate (CRR) and DOR according to the Lugano 2014 Criteria for Lymphomas
• To assess overall survival (OS)

Inclution Criteria

1. Age ≥18 years at the time of informed consent and have provided signed informed consent for the trial.
2. Willing and able to comply with all aspects of the protocol.
3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
4. Life expectancy ≥3 months.
5. a. For first-in-human dose escalation phase (Part 1) and food effect assessment (Part 2): Subjects with histologically or cytologically confirmed advanced solid tumors that are metastatic or unresectable, or relapse or refractory (r/r) lymphoma, and for whom standard life-prolonging measures are not available. Types of lymphoma may include, but are not limited to, natural killer (NK)/T-cell lymphoma, classic Hodgkin lymphoma (cHL), peripheral T-cell lymphoma (PTCL), and diffuse large B-cell lymphoma (DLBCL).
Note: Subjects diagnosed with relapsed or refractory (r/r) lymphoma if received at least one prior systemic therapy, meanwhile meeting one of the following conditions are eligible for this study:
• Not achieving a partial response (PR) or complete response (CR) after receiving two or more treatment cycles.
• Progression or recurrence after achieving PR/CR.
For CD20+ B-cell non-Hodgkin lymphoma (B-NHL) patients, have received at least one line of treatment that includes Rituximab.

Exclusion Criteria

1. Patients who have previously received immunotherapy and discontinued treatment due to a Grade 3 or higher immune-related AE (irAE) from prior anti-PD-(L)1 therapy, or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137).
2. Have received systemic anti-cancer therapy including investigational oncology agents, or investigational device within 3 weeks or 5 half-lives (whichever is shorter) prior to the first study drug administration.
Note: Participants must have recovered from all AEs due to previous therapies to ≤ Grade 1 or returned to baseline. Participants with ≤ Grade 2 neuropathy, alopecia, or hypothyroidism on thyroid hormone replacement may be eligible.

The Estimated Number of Participants

  • Taiwan

    20 participants

  • Global

    80 participants

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