First in Human, Dose Escalation Study of AN4005
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
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
Treatments tested in this trial
- AN4005-dose level 0
- AN4005-dose level 1
- AN4005-dose level 2
- AN4005-dose level 3
- AN4005-dose level 4
- AN4005-food effect
Treatment groups
31 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov