An Initial Evaluation of AN8025 in Solid Tumors

NCT07639047 | Recruiting Phase 1 DMC

• 1 other identifier: AN8025S0101
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

Brief 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. 1.Determine which dose level of AN8025 is safe and tolerability in participants with advanced solid tumors
2. 2.To determine the maximum tolerated of AN8025 for future testing.

Conditions

Advanced Solid Tumor (Phase 1)

Keywords

Advance Solid tumors; Tri-specific; PD-L1

Outcome Measures

Primary Outcomes (2)

• 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

  24 months

• Minimum Tolerated Dose/Recommended Dose for Expansion (MTD/RDE)

  Nature and frequency of dose limiting toxicities (DLTs)

  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)

• Determine the pharmacokinetics (PK) of AN8025

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

• Preliminary anti-tumor activity of AN8025, Objective Response Rate (ORR)

  24 months

• Preliminary anti-tumor activity of AN8025, Disease Control Rate (DCR)

  24 Months

• Preliminary anti-tumor activity of AN8025, Duration of Response (DOR)

  24 Months

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

  24 months

Study Arms (1)

AN2025 Treatment

EXPERIMENTAL

AN8025 is a tri-functional antibody that is a reconstituted liquid intravenously administered over the period of 60 mins.

Drug: AN8025 is a multifunctional antibody fusion protein

Interventions

AN8025 is a multifunctional antibody fusion protein DRUG

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

AN2025 Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Adlai Nortye Biopharma Co., Ltd.: lead

Study Sites (1)

Linear Clinical Research Ltd

Nedlands, Western Australia, 6009, Australia

RECRUITING

Central Study Contacts

Regulatory Operations

CONTACT

848-230-7430; ANRegCTG@adlainortye.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2025
• First Posted: June 10, 2026
• Study Start: November 1, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)