drugsProductPhase 3

ARX788

ARX788 is a HER2 ADC with a precisely placed, non-cleavable payload that beat lapatinib-capecitabine in China and showed activity in brain metastases.

Ambrx (acquired by J&J 2024) and NovoCodex. ACE-Breast-02 phase 3: PFS 11.3 vs 8.2 months (HR 0.64). ACE-Breast-06: intracranial activity in active brain metastases. Ocular and interstitial lung toxicities; FDA Fast Track; Chinese marketing application planned.

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Payload: AS269 (PEG4-aminooxy-MMAF) · 2D coordinates (no PubChem conformer)

PubChem

How it works, step by step · animated schematic, not to scale

Antibody-drug conjugate (ADC) →

Modality

ADC

Mechanism

Site-specific pAF conjugation gives homogeneous DAR ~2; non-cleavable linker limits bystander effect but improves stability.

Payload

AS269 (MMAF-like tubulin inhibitor), DAR ~1.9

Linker

Non-natural amino acid, non-cleavable

Where it is approved

USEUUKJPCNunder reviewAUcompare regions →

Compare all products across the US, EU, UK, Japan, China and Australia →

Trials

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ClinicalTrials.gov · phase 2/3

refreshed 2026-09-09

10 studies3 recruiting10 Phase 21 Phase 3

Search “ARX788” on ClinicalTrials.gov →

Counts are from a name search and may include unrelated studies; up to 100 studies are summarised.

Recruiting now (live from ClinicalTrials.gov)

Recruiting trials near you · live from ClinicalTrials.gov

ARX788

intervention: ARX788

Open on ClinicalTrials.gov →

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Landmark trials in OnCo

ACE-Breast-02

Latest papers

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Literature trend4 papers in the last 12 monthsHow this is computed

Connected

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Pages like this

not linked directly; found by shared links

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Technology
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Company
Araris Biotech (Taiho)
Shares Site-specific conjugation & linker chemistry, Antibody-drug conjugate (ADC).

Evidence strength57/100 · Solid

How much and what kind of evidence, not how big the benefit. Click for the breakdown.

Status: phase-3+22
Best linked trial: ACE-Breast-02 (77)+35
0 approval entries0

Formula disclosed on the evidence page.

Not yet reviewedNeeds expert (regulatory) and expert (clinical) and patient advocate review. Review this page or see the review queue and roster.

ProvenanceLast edited 2026-09-09 · Jude Gomila · Editing pass: every TL;DR and summary stands alone · diff · file · history

Data

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