First in Human, Dose Escalation Study of AN4005

Part of paid clinical trials in Hackensack, New Jersey.

Sponsor
Adlai Nortye Biopharma Co., Ltd.
Study ID
NCT04999384
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Advanced Lymphoma
  • Advanced Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • AN4005-dose level 0 — DRUG
    50mg BID
  • AN4005-dose level 1 — DRUG
    100mg BID
  • AN4005-dose level 2 — DRUG
    200mg BID
  • AN4005-dose level 3 — DRUG
    400mg BID
  • AN4005-dose level 4 — DRUG
    600mg BID
  • AN4005-food effect — DRUG
    Dose to be determined upon the MTD determination

Study Details

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.

Key Dates

Start date
Sep 27, 2021
Status verified
Nov 2025
Primary completion
Nov 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
31 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Active Comparator: AN4005 dose level 0
    One sentinel patient will be orally dosed at 50 mg AN4005 BID. If this dose for one cycle is deemed to be tolerable upon review of safety data and PK data, the dose of AN4005 will be escalated to next level: dose level 1.
  • Active Comparator: AN4005 dose level 1
    Three patients will be orally dosed at 100 mg AN4005 BID. Based on the number of DLT events during the first cycle, dosing decisions will be made, including add 3 patients at the same dose level (1 DLT), escalation to dose level 3 (\<1/6 DLT), de-escalate to lower dose or stop (\>1/6 DLT).
  • Active Comparator: AN4005 dose level 2
    Three patients will be orally dosed at 200 mg AN4005 BID. Based on the number of DLT events during the first cycle, dosing decisions will be made, including add 3 patients at the same dose level (1 DLT), escalation to dose level 3 (\<1/6 DLT), de-escalate to lower dose or stop (\>1/6 DLT).
  • Active Comparator: AN4005 dose level 3
    Three patients will be orally dosed at 400 mg AN4005 BID. Based on the number of DLT events during the first cycle, dosing decisions will be made, including add 3 patients at the same dose level (1 DLT), escalation to dose level 4 (\<1/6 DLT), de-escalate to lower dose or stop (\>1/6 DLT).
  • Active Comparator: AN4005 dose level 4
    Three patients will be orally dosed at 600 mg AN4005 BID. Based on the number of DLT events during the first cycle, dosing decisions will be made, including add 3 patients at the same dose level (1 DLT), de-escalate to lower dose or stop (\>1/6 DLT).
  • Active Comparator: AN4005 food effect
    The effect of a high-fat meal on the PK of AN4005 will be evaluated in a separate cohort of approximately 6 patients after a safe and clinically relevant dose is identified during the dose finding part of the study.

Primary Outcome Measure

Number of participants with any adverse events (AEs), serious adverse events (SAEs), withdrawal due to AEs, dose interruptions and reductions [ Time Frame: Up to approximately 1 year ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Hackensack University Medical CenterHackensackNew Jersey07601
Chelsea M
[email protected]
551-996-4725
Montefiore Einstein Cancer CenterThe BronxNew York10461
Gunnar Lauer
[email protected]
718-405-8124
Prisma Health Institute for Translational Oncology ResearchGreenvilleSouth Carolina29605
Fiona Davidson
[email protected]
864-455-3737
Next VirginiaFairfaxVirginia22031
Melissa Galan
[email protected]
210-580-9500

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Hackensack University Medical Center· Hackensack, NJMontefiore Einstein Cancer Center· The Bronx, NYPrisma Health Institute for Translational Oncology Research· Greenville, SCNext Virginia· Fairfax, VA

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