ARX788

Phase 3Small molecule

FFudan University

ARX788 is one of 76 small molecule programs targeting Breast Cancer. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Breast CancerActive, not recruiting

Metastatic Breast CancerRecruiting

Breast CancerPhase 3

Active, not recruiting

Metastatic Breast CancerPhase 2

Recruiting

Competition

Competitive Landscape

706 competitors in Breast Cancer

#DrugCompanyPhaseTrials

ARX788

FFudan University

Phase 3

7 2

Adenocard

Astellas

Preclinical

2 3

Voltaren

Novartis

Preclinical

1 4

Blenoxane

Bristol-Myers Squibb

Preclinical

1 5

Duragesic-100

CCephalon

Preclinical

2 6

Tricor

JJagotec

Preclinical

1 7

Cortef

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Preclinical

1 8

Neoadjuvant Treatment

SShanghai Zhongshan Hospital

Preclinical

1 9

Recombinant Human Endostatin

PPeking University Third Hospital

Preclinical

1 10

Tianeptine

Pfizer

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q2 2027

Phase 2Active, not recruiting

Breast Cancer

NCT04829604

Q4 2028

Phase 2/3Active, not recruiting

Breast Cancer

NCT05426486

Q2 2029

Phase 2Not yet recruiting

Breast Cancer

NCT06224673

Q4 2029

Phase 2Recruiting

Metastatic Breast Cancer

NCT06663748

Clinical

Trials by Indication[1]

Breast Cancer7 trials

ARX788 for Treating Patients With HER2-low Locally Advanced Unresectable or Metastatic Breast Cancer

Not yet recruiting·LLaura Huppert, MD, BA·Phase 2·NCT06224673·36 enrolled

ARX788 in Breast Cancer With Low Expression of HER2

Unknown status·FFudan University·Phase 2·NCT05018676·54 enrolled

I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer

Recruiting·QQuantumLeap Healthcare Collaborative·Phase 2·NCT01042379·5,000 enrolled

Show 4 more trials

A Study of ARX788 Combined With Pyrotinib Maleate Versus TCBHP (Trastuzumab Plus Pertuzumab With Docetaxel and Carboplatin) as Neoadjuvant Treatment in HER2-positive Breast Cancer Patients

Active, not recruiting·CCaigang Liu·Phase 2/3·NCT05426486·136 enrolled

ARX788 in HER2-positive Breast Cancer Patients With Brain Metastases

Unknown status·FFudan University·Phase 2·NCT05018702·32 enrolled

ARX788 in HER2-positive, Metastatic Breast Cancer Subjects (ACE-Breast-03)

Active, not recruiting·AAmbrx, Inc.·Phase 2·NCT04829604·72 enrolled

ARX788 in HER2-positive Metastatic Breast Cancer Patients Who Were Previously Treated With T-DXd

Not yet recruiting·FFudan University·Phase 2·NCT06578286·44 enrolled

Advanced Cancers1 trial

A Dose-escalation Study of ARX788, IV Administered in Subjects With Advanced Cancers With HER2 Expression

Terminated·ZZhejiang Medicine Co., Ltd.·Phase 1·NCT02512237·9 enrolled

Advanced Solid Tumors1 trial

A Dose-escalation, Expansion Study of ARX788, in Advanced Solid Tumors Subjects With HER2 Expression (ACE-Pan Tumor 01)

Completed·AAmbrx, Inc.·Phase 1·NCT03255070·106 enrolled

Solid Tumors1 trial

ARX788 in Selected HER2-mutated or HER2-amplified/Overexpressed Solid Tumors (ACE-Pan Tumor-02)

Withdrawn·AAmbrx, Inc.·Phase 2·NCT05041972

Metastatic Breast Cancer1 trial

Evaluate the Efficacy and Safety of ARX788 Given Every 6 Weeks in Patients With HER2-positive Advanced Breast Cancer

Recruiting·HHenan Cancer Hospital·Phase 2·NCT06663748·44 enrolled

Sources

References

[1]
ClinicalTrials.gov — 11 trial records for ARX788. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — ARX788 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for ARX788. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Fudan University company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: FFudan University

ARX788

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q2 2027

Q4 2028

Q2 2029

Q4 2029

Trials by Indication[1]

Breast Cancer7 trials

Advanced Cancers1 trial

Advanced Solid Tumors1 trial

Solid Tumors1 trial

Metastatic Breast Cancer1 trial

References

Drug Info

Quick Facts

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