None listed
Conditions
Brief summary
This study will assess the safety and tolerability of a new anti-cancer drug, AN8025, to determine the safest dose that can be given to adults with advanced or metastatic solid tumours. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with an advanced or metastatic cancer, this may be non-small cell lung cancer, melanoma (skin cancer) or another type of cancer that presents as solid tumours. Participants will also need to complete additional health checks by a doctor to determine if it is safe for them to enter this study. Study details All participants who choose to enrol in this study will be given AN8025 once every 3 weeks. Treatment will continue until the body can no longer tolerate the drug, the disease progresses, or the participant decides to stop taking part in the study. Different groups of participants will be enrolled to test higher doses of AN8025, once the starting dose has been determined to be safe. Participants will be asked to provide blood samples and keep a diary of any side effects that they experience after taking AN8025. It is hoped this research will determine that use of AN8025 is safe and tolerable for patients with advanced or metastatic cancer, and that this study will determine the highest safe dose for patients with cancer. Once the safest dose is determined, a larger study enrolling a greater number of cancer patients may go ahead.
Interventions
This is a first-in-human phase I study to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of AN8025 in participants with unresectable advanced or metastatic solid tumours. The maximum tolerated dose (MTD) and the recommended dose for expansion (RDE) will also be investigated in this study. AN8025 is given 7.5 microgram (mg) as the starting dose, every 3 weeks by intravenous infusion until unacceptable toxicity or disease progression. When it’s
This is a first-in-human phase I study to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of AN8025 in participants with unresectable advanced or metastatic solid tumours. The maximum tolerated dose (MTD) and the recommended dose for expansion (RDE) will also be investigated in this study. AN8025 is given 7.5 microgram (mg) as the starting dose, every 3 weeks by intravenous infusion until unacceptable toxicity or disease progression. When it’s safe, 25mg, 75mg, 250mg, 750mg, 1200mg, 1500mg will be studied separately in order to establish a safe and recommended dose for further study. AN8025 is given only under the supervision of study investigators.
Sponsors
Adlai Nortye Biopharma Co., Ltd.
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Aged >=18 years old. 2. Able to provide informed consent obtained before any study-related activities and according to local guidelines. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. 4. Have an estimated life expectancy >=12 weeks, in the judgment of the investigator. 5. Have histological or cytological evidence of a diagnosis of cancer that is advanced and/or metastatic with progression after treatment with available standard therapies or are intolerant to or refuse standard therapies that are known to provide clinical benefit. 6. Have adequate hematologic function and major organ function, defined by laboratory assessment documented within 7 days prior to first dose of study treatment: a. Absolute neutrophil count (ANC) >=1.5 x 109/L. b. Hemoglobin >= 9 g/dL (which may be reached by transfusion >=2 weeks prior to the sample collection at screening). c. Platelets >= 100 x 109/L (which may be reached by transfusion >=2 weeks prior to the sample collection at screening). d. International normalized ratio (INR) <= 1.5. e. Alanine aminotransferase (AST) and aspartate aminotransferase (ALT) <=2.5 x upper limit of normal (ULN) or <= 5.0 x ULN if liver metastases are present. f. Total bilirubin <= 1.5 x ULN or <= 3.0 x ULN if Gilbert’s syndrome is present. g. Serum creatinine 50 mL/min. h. Thyroid stimulating hormone (TSH) within normal limits. If TSH is not within normal limits at baseline, the participant will still be eligible if total T3 or free T3 (FT3) and free T4 (FT4) are within the normal limits. 7. Have discontinued previous cancer treatment and recovered from the acute toxicity of therapy.
Exclusion criteria
1. 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. 2. Have a serious concomitant systemic disorder that, in the judgment of the investigator, would compromise the participant’s ability to adhere to the protocol. 3. Known human immunodeficiency virus (HIV) infection per HIV 1 and/or 2 antibodies. 4. Participants with evidence of Hepatitis B or Hepatitis C infections (positive for Hepatitis B surface antigen [HBsAg] or Hepatitis C antibody) must fulfill the following criteria in order to be eligible for the study: a. Hepatitis B virus (HBV) viral load <= 2500 copies or =3 months, throughout treatment and for 6 months after; and b. Hepatitis C virus (HCV) viral load <= lower limits of detection, participants with curable or controllable HCV infection are eligible. Participants with detectable HCV RNA can remain on continuous, effective antiviral therapy during the study. Note: The necessity of conducting HBV DNA/HCV RNA quantitative testing is based on the local epidemiology and local clinical practice. 5. Active tuberculosis. 6. Active infection requiring intravenous therapy. 7. Prior or second concurrent primary malignancies that, in the judgment of the investigator, may affect the interpretation of results. Participants with carcinoma in situ of any origin and participants with prior malignancies who are in remission and whose likelihood of recurrence is very low (such as basal cell carcinoma), as judged by the investigator, are eligible for this study. 8. Evidence of (a) interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity (for example, interstitial lung disease); (b) active, noninfectious pneumonitis; or (c) history of noninfectious pneumonitis that required corticosteroid therapy or immune related pneumonitis. 9. Moderate or severe cardiovascular disease, including: a. A myocardial infarction or any other arterial thrombotic event including cerebrovascular accident or transient ischemic attack within 6 months prior to enrollment; b. Unstable angina pectoris; c. New York Heart Association Class III/IV congestive heart failure; d. Aneurysm of major vessels or heart; e. Left ventricular ejection fraction <50% (evaluation based on institutional lower limit of normal); f. Uncontrolled hypertension; g. Moderate, severe or clinically significant valvulopathy; h. Documented major ECG abnormalities that, in the judgment of the investigator, are clinically significant (for example, arrhythmia requiring treatment) i. Mean QTc =470 ms calculated using Fridericia’s correction and confirmed by triplicate ECG. 10. Have symptomatic central nervous system (CNS) malignancy or metastasis (screening not required). Participants with treated CNS metastases are eligible for this study if they are not requiring concurrent treatment, including but not limited to surgery, radiation, corticosteroids and/or anticonvulsants to treat CNS metastases, and their disease is asymptomatic and radiographically stable for at least 30 days. 11. Have a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant’s participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.
Outcome results
None listed