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 groups

6

Treatment groups

See each treatment group below.

Locations

7
China
Beijing Cancer Hospital100142, BeijingBeijing Municipality, China
Harbin Medical University Cancer Hospital150081, HarbinHeilongjiang, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology430000, WuhanHubei, China
United States
Hackensack University Medical Center07601, HackensackNew Jersey, United States

Sponsors and collaborators

Adlai Nortye Biopharma Co., Ltd.

Lead sponsor