Health TrialsbyHealthPanel

First in Human, Dose Escalation Study of AN4005

ConditionsAdvanced Solid TumorAdvanced Lymphoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorAdlai Nortye Biopharma Co., Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. Age ≥ 18 years at the time of informed consent and have provided signed informed consent for the trial.

Absolute neutrophil count (ANC) ≥1.5 x 109/L.

Hemoglobin ≥8 g/dL (which may be reached by transfusion).

Platelets ≥100 x 109/L (which may be reached by transfusion).

Disqualifiers

Have been discontinued treatment due to a Grade 3 or higher immune-related AE (irAE) from prior anti-PD-1or anti-PD-L1 therapy, or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137).

Have received prior systemic anti-cancer therapy including investigational oncology agents within 4 weeks or 5 half-lives, whichever is shorter.

At least 6 weeks must have elapsed since CAR-T infusion and subjects must have experienced disease progression, and not have residual circulating CAR-T cells in peripheral blood (based on local assessment). Any encountered treatment-related toxicities must have resolved to Grade ≤1.

Have received prior palliative radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤ 2 weeks of radiotherapy) to non-central nervous system (CNS) disease.

Trial design

Design model

Sequential

Treatments tested in this trial

  • 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

Treatment groups

31 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: AN4005 dose level 0Active comparator 1 intervention
Group B: AN4005 dose level 1Active comparator 1 intervention
Group C: AN4005 dose level 2Active comparator 1 intervention
Group D: AN4005 dose level 3Active comparator 1 intervention
Group E: AN4005 dose level 4Active comparator 1 intervention
Group F: AN4005 food effectActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants with any adverse events (AEs), serious adverse events (SAEs), withdrawal due to AEs, dose interruptions and reductions

All AEs, SAEs and dose modifications will be collected

Time frame
Up to approximately 1 year
2

Number of participants with dose limiting toxicities (DLTs)

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

Time frame
Up to 28 days
3

Number of participants with clinically significant changes in laboratory parameters, vital signs, physical examination and organ-specific parameters

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

Time frame
Up to approximately 1 year

Secondary outcomes

1

Maximum observed plasma concentration (Cmax) of AN4005

Blood samples will be collected at given time points to determine the Cmax of AN4005

Time frame
Baseline and up to approximately 1 year
2

Area under the plasma concentration-time curve (AUC) extrapolated from time zero to infinity (AUC[0-inf]) of AN4005

Blood samples will be collected at given time points to determine the AUC (0-inf) of AN4005

Time frame
Up to approximately 1 year
3

AUC from time zero to the last quantifiable concentration after dosing (AUC[0-t]) of AN4005

Blood samples will be collected at given time points to determine the AUC (0-t) of AN4005

Time frame
Up to approximately 1 year
4

AUC over the dosing interval tau (AUC[0-tau]) of AN4005

Blood samples will be collected at given time points to determine the AUC (0-tau) of AN4005

Time frame
Up to approximately 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Adlai Nortye Biopharma Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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