An Initial Evaluation of AN8025 in Solid Tumors
ConditionAdvanced Solid Tumor (Phase 1)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorAdlai Nortye Biopharma Co., Ltd.
About this trial
The goal of this clinical trial is to determine the appropriate dose of AN8025 for use in the treatment of advanced solid tumors. This study will be conducted in in adults \>18 years of age. The main questions to answer:
1. Determine which dose level of AN8025 is safe and tolerability in participants with advanced solid tumors 2. To determine the maximum tolerated of AN8025 for future testing.
Participants will visit their study site in 3 week cycles, during which they will be under go treatment with AN8025 and visit their clinical site during each cycle for check ups and testing.
Eligibility criteria
Qualifiers
Aged ≥18 years old.
Able to provide informed consent obtained before any study-related activities and according to local guidelines.
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
Have an estimated life expectancy ≥ 12 weeks, in the judgment of the investigator.
Disqualifiers
Are currently enrolled in a clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.
Have a serious concomitant systemic disorder that, in the judgment of the investigator, would compromise the participant's ability to adhere to the protocol.
Known human immunodeficiency virus (HIV) infection per HIV 1 and/or 2 antibodies.
Hepatitis B virus (HBV) viral load ≤2500 copies or ≤500 IU/mL before study enrollment, and participants with active HBV need to be on anti-HBV suppression ≥3 months, throughout treatment and for 6 months after; and
Trial design
Treatments tested in this trial
- AN8025 is a multifunctional antibody fusion protein
Treatment groups
91 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov