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New treatment option for Advanced Solid Tumor (Phase 1)
Official title An Initial Evaluation of AN8025 in Solid Tumors
ClinicalTrials.gov ID: NCT07639047
What this study is testing
What is AN8025 is a multifunctional antibody fusion protein?
AN8025 is a multifunctional antibody fusion protein is an investigational medicine, being studied as a potential treatment for advanced solid tumor (phase 1).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Time commitment: about 24 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
- Have histological or cytological evidence of a diagnosis of cancer that is advanced and/or metastatic with progression after treatment with available...
You likely can't join if
- Are currently enrolled in a clinical study involving an investigational product or any other type of medical research judged not to be scientifically...
- Have a serious concomitant systemic disorder that, in the judgment of the investigator, would compromise the participant's ability to adhere to the...
- Known human immunodeficiency virus (HIV) infection per HIV 1 and/or 2 antibodies.
- Participants with evidence of Hepatitis B or Hepatitis C infections (positive for Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody) must...
- 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...
- Hepatitis C virus (HCV) viral load ≤lower limits of detection, participants with curable or controllable HCV infection are eligible. Participants...
See the full eligibility criteria
Who can join
- 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.
- 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...
- Part A Dose Escalation only: Participants have unresectable advanced or metastatic solid tumors, with no preference of cancer type.
- Part B Dose Expansion only: Participants enrolled into tumor-specific cohorts have unresectable advanced metastatic disease. Participants must also have progressed after treatment with the appropriate targeted therapy...
- The participant has received at least 2 doses of an approved anti-PD-1/PD-L1 monoclonal antibody
- The participant has demonstrated progressive disease (PD) after anti-PD-1/PD-L1 therapy as defined by RECIST Version 1.1, which was subsequently confirmed by a second assessment no less than 4 weeks from the date of the...
- Participants who have received anti-PD-1/PD-L1 therapy as part of their adjuvant therapy but experienced recurrence with locally advanced or metastatic disease within 6 months after completing adjuvant therapy may be...
- Part B Dose Expansion only: Participants enrolled into the expansion cohort must have documented PD-L1 tumor expression on ≥1% tumor cells (i.e. TPS or TC ≥1%) as assessed by validated immunohistochemistry (IHC) assay...
- Participants have consented to provide archival tumor tissue collected within 5 years or a newly obtained core or excisional biopsy of a tumor lesion not previously irradiated. Archival tumor tissue can be...
- Have at least one measurable lesion as defined per RECIST v1.1. Bone metastases are not considered measurable. Participants who only have non-measurable lesion(s) may be eligible for Part A, except for "back-filled"...
- Have adequate hematologic function and major organ function, defined by laboratory assessment documented within 7 days prior to first dose of study treatment:
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L.
- Hemoglobin ≥ 9 g/dL (which may be reached by transfusion).
- Platelets ≥ 100 x 109/L (which may be reached by transfusion).
- International normalized ratio (INR) ≤ 1.5.
- 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.
- Total bilirubin ≤ 1.5 x ULN or ≤ 3.0 x ULN if Gilbert's syndrome is present.
- Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCL) \> 50 mL/min.
- 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.
- Have discontinued previous cancer treatment and recovered from the acute toxicity of therapy. Participants must have discontinued from previous treatment with length of time prior to first dose of study treatment.
- Fertile men and women of childbearing potential must agree to use an effective method of birth control from providing signed consent and for 180 days after the last study treatment administration. Women of childbearing...
What rules you out
- 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.
- 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:
- 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
- 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...
- Active tuberculosis.
- Active infection requiring intravenous therapy.
- 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...
- Have an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine...
- Resolved childhood asthma/atopy or who require intermittent use of bronchodilators or corticosteroid;
- Raynaud's syndrome; or
- Sjogren's syndrome. Use of topical, ophthalmic, inhaled, and intranasal corticosteroids are permitted.
- 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...
- Moderate or severe cardiovascular disease, including:
- A myocardial infarction or any other arterial thrombotic event including cerebrovascular accident or transient ischemic attack within 6 months prior to enrollment;
- Unstable angina pectoris;
- New York Heart Association Class III/IV congestive heart failure;
- Aneurysm of major vessels or heart;
- Left ventricular ejection fraction \<50% (evaluation based on institutional lower limit of normal);
- Uncontrolled hypertension;
- Severe, moderate, or clinically significant valvulopathy;
- Documented major ECG abnormalities that, in the judgment of the investigator, are clinically significant (for example, arrhythmia requiring treatment)
- Mean QTc ≥470 ms calculated using Fridericia's correction and confirmed by triplicate ECG.
- History of Grade ≥ 3 immune related Adverse Events (irAE) related to prior immune checkpoint inhibitor therapy or any active or unresolved AE from prior anti-cancer therapy that has not resolved to ≤ Grade 1 or baseline...
- Participants permanently discontinued due to any immune-related toxicity requiring prolonged (≥10 weeks) high-dose corticosteroids (≥20 mg/day prednisone equivalent) or other immunosuppressants (e.g., infliximab...
- 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...
- Have received a live vaccine within 30 days before the first dose of study treatment. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, rabies...
- Are pregnant or planning to become pregnant during the study or within 6 months following the last dose of AN8025. Plan to be breastfeeding from C1D1 of study or within 6 months following the last dose of AN8025.
- 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...
- Use of other herbal supplements, traditional medicines, or prescription medications that are known or suspected to interact with the investigational product or effect disease treatment/side effect management, as...
The study team makes the final eligibility decision.
Where it's taking place
- Nedlands, Western Australia, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 24 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nedlands, Western Australia, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.