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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
AN8025 is a multifunctional antibody fusion protein
DrugAN8025 is being developed for the treatment of advanced or metastatic solid tumors, which may include PD(L)-1 refractory advanced solid tumors
Treatment groups
91 Participants
are divided into 1 treatment groupGroup A: AN2025 TreatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety of AN8025
Incidence, nature and severity of adverse events (AEs) according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time frame
24 months2
Minimum Tolerated Dose/Recommended Dose for Expansion (MTD/RDE)
Nature and frequency of dose limiting toxicities (DLTs)
Time frame
At the end of the DLT cycle, defined as 28 days from the first dose of study treatment (Cycle1 Day1) or from Cycle1 Day1 through Cycle2 Day7, whichever is longer. Note: Treatment cycles are 21 days in length and the DLT cycle is 28 days in length.Secondary outcomes
1
Determine the pharmacokinetics (PK) of AN8025
Serum concentrations of AN8025 will be summarized using descriptive statistics. maximum concentration (CMax) for single dose and multiple dose administration will be determined and summarized using descriptive statistics by dose level.
Time frame
Days 1,2,3,8,15 during identified cycles (Cycles 1-5)2
Preliminary anti-tumor activity of AN8025, Objective Response Rate (ORR)
Derived based on RECIST v.1.1, ORR is defined as the proportion of participants with best overall response of Complete Response (CR) or Partial Response (PR) by investigator review.
Time frame
24 months3
Preliminary anti-tumor activity of AN8025, Disease Control Rate (DCR)
DCR is defined as the proportion of participants with a Best Overall Response (BOR) of CR, PR, stable disease (SD) or non-CR/non-PD by investigator review.
Time frame
24 Months4
Preliminary anti-tumor activity of AN8025, Duration of Response (DOR)
DOR is defined only for the responder subset (i.e., participants with confirmed CR or PR). DOR is defined as the elapsed time between the date of first documented response (CR or PR) and the earlier date of the first documented progression or death due to any caus
Time frame
24 MonthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov