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Advanced Solid Tumor (Phase 1)Phase 1NCT07639047

An Initial Evaluation of AN8025 in Solid Tumors

A Phase 1 study testing AN8025 is a multifunctional antibody fusion protein in people with Advanced Solid Tumor (Phase 1), run by Adlai Nortye Biopharma Co., Ltd. at 1 site in Australia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumor (Phase 1)
What is being tested?
AN8025 is a multifunctional antibody fusion protein
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
91 participants
Where
1 siteAustralia
Study dates
1 Nov 2025to Jan 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to 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 that are known to provide clinical benefit.
  • Part A Dose Escalation only: Participants have unresectable advanced or metastatic solid tumors, with no preference of cancer type.
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  • 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. Participants must be primary refractory or non-responding to anti-PD-1 monotherapy as defined by:
  • 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 first documented PD to rule out pseudo-progression.
  • 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 eligible for Part B.
  • 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 on archival or fresh tumor tissue.
  • 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 formalin-fixed, paraffin embedded (FFPE) tissue blocks or at least 15 freshly-sectioned slides. Tissue should be obtained from surgical resection or core needle biopsy. Fine-needle aspiration (FNA), pleural effusion, or ascitic fluid samples are not acceptable. FFPE blocks are preferred to slides and newly obtained biopsies are preferred to archival tissue. For participants who have consented to provide newly obtained fresh biopsy of baseline tumor tissue, the biopsy is required to be collected during the screening period. Tissue requirements may be waived on a case-by-case basis after discussion with the sponsor if tissue or biopsy is not available or feasible.
  • 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" cohorts.
  • 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 potential include pre-menopausal women and women within the first 2 years of the onset of menopause. Women of childbearing potential must have a negative pregnancy test ≤ 7 days prior to the first dose of the study treatment.

Who cannot join

  • 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 therapy during the study.
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  • Note: The necessity of conducting HBV DNA/HCV RNA quantitative testing is based on the local epidemiology and local clinical practice.
  • 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 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.
  • 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, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed. This criterion does not apply to participants with:
  • 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, noninfectious pneumonitis; or (c) history of noninfectious pneumonitis that required corticosteroid therapy or immune related pneumonitis.
  • 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 (except controlled endocrinopathies). Participants with a history of Grade ≥3 irAEs attributed to prior anti-CTLA4 (e.g. ipilimumab) combined with anti-PD(L)1 (e.g. pembrolizumab, nivolumab, atezolizumab) are eligible for enrollment if the irAE occurred during combination therapy, and they subsequently tolerated anti-PD(L)1 monotherapy without recurrence of Grade ≥3 irAEs.
  • 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, mycophenolate, cyclophosphamide) will be excluded.
  • 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.
  • 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, Bacillus Calmette-Guérin, and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (for example, FluMist®) are live attenuated vaccines and are not allowed.
  • 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 is not in the best interest of the participant to participate, in the opinion of the treating investigator.
  • 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 determined by the study investigator

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Regulatory Operations contact

848-230-7430

ANRegCTG@adlainortye.com

Australia1 site, 1 recruiting

  • Linear Clinical Research Ltd

    Nedlands, Western Australia, 6009

    L Warburton, MD, +61 8 6382 5100, adminaus@TigermedGrp.com

    Recruiting

Other trials in Australia

About this study

Official title: Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of AN8025 in Participants With Unresectable Advanced or Metastatic Solid Tumors

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.

Read the detailed description

This is a first-in-human, open label, multi-center, multiple-ascending dose escalation, phase I study to test AN8025. After confirmation of meeting the study entry criteria, participants with advanced solid tumors will be in 1 of two parts of the study: Part A (dose escalation) and Part B (dose expansion). The study will take place in Australia and China, with approximately 4 sites in each country.

Each part of this study has 3 phases of participation: Screening Phase (up to 35 days prior to dosing), Treatment Phase (21-day cycles, dosing on the first day of each cycle), and a Follow Up Phase . Participants will have up to 35 days to enter the study (the screening phase), during which it will be determined if they qualify for the study. After confirmation of eligibility, participants will be enrolled into the treatment phase of the study for up to 24 months, or until experiencing drug toxicity, progressive disease, withdrawal of consent or death. Participant follow up will include an End of Treatment Visit (EoT), a 30-day safety follow up visit, and survival follow up contact every 3 months after the EoT visit until 6 months after EoT visit or 12 months from Cycle 1 Day1, whichever is longer. The study is projected to last approximately 50 months.

During the course of the study, treatment will be once every 21 days, with visits to the clinic required to undergo testing to determine the side effects, safety and efficacy of AN8025, including testing to characterized the drug level in a participants blood.

The goal of the study is to determine the dose level of AN8025 that is safe and tolerable to treat patients with advanced solid tumors. Once identified, the study will enroll in up 2, 20 patient expansion cohorts in advanced solid tumors (to be identified based on dose expansion). The pharmacokinetic (PK) profile of AN2025 will be determined in this population, along with any preliminary anti-tumor activity.

Being tested
AN8025 is a multifunctional antibody fusion protein
Keywords
Advance Solid tumors, Tri-specific, PD-L1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AN8025 is a multifunctional antibody fusion proteinDrug

    AN8025 is being developed for the treatment of advanced or metastatic solid tumors, which may include PD(L)-1 refractory advanced solid tumors

Study groups in NCT07639047
Study groupRoleWhat they receive
AN2025 TreatmentExperimentalAN8025 is a tri-functional antibody that is a reconstituted liquid intravenously administered over the period of 60 mins.
Receives: Drug: AN8025 is a multifunctional antibody fusion protein

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 24 months

  2. Minimum Tolerated Dose/Recommended Dose for Expansion (MTD/RDE)

    Nature and frequency of dose limiting toxicities (DLTs)

    Measured: 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 (9)

  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.

    Measured: 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.

    Measured: 24 months

  3. 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.

    Measured: 24 Months

  4. 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

    Measured: 24 Months

  5. Preliminary anti-tumor activity of AN8025, Progression Free Survival (PFS)

    PFS is defined as the time from the date of the first dose of study drug to the date of the first documentation of disease progression or death, whichever occurs first.

    Measured: 24 months

  6. Determine the pharmacokinetics (PK) of AN8025

    Time to maximum serum concentration of AN8025 will be summarized using descriptive statistics for single dose and multiple dose administration.

    Measured: Days 1,2,3,8,15 during identified cycles (Cycles 1-5)

  7. Determine the pharmacokinetics (PK) of AN8025

    Serum trough concentrations of AN8025 will be summarized using descriptive statistics by scheduled time-points and dose level.

    Measured: Days 1,2,3,8,15 during identified cycles (Cycles 1-5)

  8. Determine the pharmacokinetics (PK) of AN8025

    Area under the curve serum concentration for AN8025 will be summarized using descriptive statistics by scheduled time-points and dose level.

    Measured: Days 1,2,3,8,15 during identified cycles (Cycles 1-5)

  9. Determine the pharmacokinetics (PK) of AN8025

    Half-life analyses for serum concentrations of AN8025 will be evaluated to determine the persistence of drug exposure and characterize the elimination kinetics following for single dose and multiple dose administration.

    Measured: Days 1,2,3,8,15 during identified cycles (Cycles 1-5)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2026
  2. Study start1 Nov 2025
  3. Primary completionJul 2027 (estimated)
  4. Study completionJan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
91 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07639047
Sponsor's protocol ID
AN8025S0101
Status last verified
Jun 2026
First submitted
30 Jun 2025
Last updated
10 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AN8025 is a multifunctional antibody fusion protein in people with Advanced Solid Tumor (Phase 1), run by Adlai Nortye Biopharma Co., Ltd. at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Regulatory Operations (848-230-7430, ANRegCTG@adlainortye.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety of AN8025 (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07639047.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.

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