Adlai Nortye (NASDAQ: ANL) doses first patient in weekly AN9025 trial arm
Rhea-AI Filing Summary
Adlai Nortye Ltd. reported dosing the first U.S. patient in the intermittent weekly (QW) arm of its ongoing global Phase 1 trial of AN9025, an oral pan-RAS(ON) inhibitor for advanced or metastatic solid tumors with RAS mutations. With this milestone, both the once-daily (QD) and weekly (QW) dose-escalation arms are enrolling, and the company plans to share initial Phase 1 dose-escalation data from the QD arm in 1H27, with a potential early look at the QW arm.
The first-in-human, multicenter, open-label study evaluates the safety, tolerability, pharmacokinetics and anti-tumor activity of AN9025 and is being run as a multi-regional clinical trial in collaboration with ASK Pharm. Adlai Nortye holds ex-China rights to AN9025, while ASK Pharm retains rights in mainland China, Hong Kong and Macao. AN9025, described as an oral small molecule pan-RAS(ON) inhibitor with best-in-class potential based on preclinical data, is a key part of Adlai Nortye’s broader oncology pipeline alongside additional RAS pathway and PD-1/L1-targeting candidates.
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Key Figures
Trial phase: Phase 1
First patient dosing date: July 16, 2026
Initial data timing: 1H27
3 metrics
Trial phase
Phase 1
Phase 1 clinical trial of AN9025 in advanced or metastatic solid tumors with RAS mutations
First patient dosing date
July 16, 2026
Date the first U.S. patient was dosed in the intermittent weekly (QW) arm
Initial data timing
1H27
Planned timing to share initial Phase 1 dose-escalation data from the QD arm of AN9025
Key Terms
pan-RAS(ON) inhibitor, therapeutic window, multi-regional clinical trial, pharmacokinetics, +1 more
5 terms
pan-RAS(ON) inhibitor medical
"ongoing Phase 1 clinical trial of AN9025, a pan-RAS(ON) inhibitor"
A pan-RAS inhibitor is a drug designed to block the activity of the RAS family of proteins, which act like on/off switches controlling cell growth and survival. By targeting multiple RAS isoforms or mutation types at once, these medicines aim to stop signals that drive many cancers, so their trial results and approval potential can affect biotech valuations and the outlook for cancer-treatment pipelines much like a single key that can lock several similar doors at once.
therapeutic window medical
"weekly dosing could widen the therapeutic window, enabling higher dosing"
The "therapeutic window" is the optimal range of a medication's dosage where it effectively treats a condition without causing harmful side effects. For investors, understanding this concept highlights the importance of balance—just as too little medication may be ineffective and too much can be dangerous, financial strategies or investments need to be carefully managed within safe limits to achieve desired results without undue risk.
multi-regional clinical trial regulatory
"as a multi-regional clinical trial (MRCT) pursuant to a license agreement"
A multi-regional clinical trial tests a drug or medical device at study sites in several different countries or geographic regions at the same time, so results reflect how it works across diverse populations and health systems. For investors, these trials matter because they can speed enrollment, strengthen regulatory credibility and market access across territories, but also increase complexity, cost and timing—like testing a car in multiple climates to prove it works everywhere.
pharmacokinetics medical
"designed to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity"
Pharmacokinetics is the study of how a substance, such as a drug or chemical, moves through and is processed by the body over time. It tracks how it is absorbed, distributed, broken down, and eventually eliminated. For investors, understanding pharmacokinetics helps gauge the effectiveness, safety, and potential risks of new medications or treatments, which can influence a company’s success and valuation in the healthcare industry.
PD-L1 inhibitor medical
"AN4005, a first-in-class oral PD-L1 inhibitor"
A PD-L1 inhibitor is a type of cancer drug that blocks a protein tumors use to hide from the immune system, allowing immune cells to recognize and attack cancer. Think of it as removing a stealth cloak or releasing a brake on the body’s defenses; that can shrink tumors or slow growth. Investors watch these drugs because successful trials, approvals, or partnerships can drive sales, affect a company’s valuation, and reshape treatment standards.
AI-generated analysis. How Rhea-AI works. Not financial advice.
FAQ
What did Adlai Nortye (ANL) announce about its AN9025 clinical trial?
Adlai Nortye announced that the first U.S. patient was dosed in the intermittent weekly (QW) arm of its global Phase 1 trial of pan-RAS(ON) inhibitor AN9025. Both the once-daily (QD) and weekly (QW) dose-escalation arms in advanced RAS-mutant solid tumors are now enrolling.
What is AN9025 in Adlai Nortye’s (ANL) pipeline and which cancers is it targeting?
AN9025 is an oral small molecule pan-RAS(ON) inhibitor designed to target a broad spectrum of RAS mutations across tumor types. Preclinical studies showed potent and durable activity in RAS-mutant cancers, including pancreatic, lung and colorectal adenocarcinomas, with results comparable or superior to a benchmark agent.
How is the Phase 1 AN9025 study for Adlai Nortye (ANL) designed?
The AN9025 study is a first-in-human, multicenter, open-label Phase 1 trial. It evaluates safety, tolerability, pharmacokinetics and anti-tumor activity in patients with advanced or metastatic solid tumors harboring RAS mutations, and is being conducted as a multi-regional clinical trial in collaboration with ASK Pharm.
When does Adlai Nortye (ANL) expect initial Phase 1 data for AN9025?
Adlai Nortye plans to share initial Phase 1 dose-escalation data from the once-daily (QD) arm of AN9025 in 1H27, with a potential early look at the intermittent weekly (QW) arm. This timing guidance relates specifically to the ongoing global first-in-human study.
How are rights to AN9025 divided between Adlai Nortye (ANL) and ASK Pharm?
Under a license agreement, Adlai Nortye retains ex-China rights to AN9025, while Jiangsu Aosaikang Pharmaceutical Co. Ltd. (ASK Pharm) holds rights in mainland China, Hong Kong and Macao. The current multi-regional Phase 1 trial is being conducted collaboratively under this structure.
What other oncology programs are in Adlai Nortye’s (ANL) portfolio besides AN9025?
Adlai Nortye’s pipeline includes precision RAS pathway therapies like AN4035, a CEACAM5-targeting ADC from its RASiCA platform, and next-generation PD-1/L1 immunotherapies such as AN8025, a multi-functional fusion protein, and AN4005, a first-in-class oral PD-L1 inhibitor.