ARX788

DRUG11 trials

Sponsors

QuantumLeap Healthcare Collaborative, Zhejiang Medicine Co., Ltd., Ambrx, Inc., Fudan University, Caigang Liu

Conditions

AngiosarcomaBreast CancerBreast Cancer With Low Expression of HER2Breast NeoplasmsBreast TumorsEarly-stage Breast CancerGastric NeoplasmHER2 Amplified Solid Tumors

Phase 1

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

TerminatedNCT02512237

Zhejiang Medicine Co., Ltd.Breast Neoplasms, Stomach Neoplasms

Start: 2016-03-31End: 2017-01-31Updated: 2020-06-05

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

CompletedNCT03255070

Ambrx, Inc.Breast Neoplasms, Gastric Neoplasm, Solid Tumors

Start: 2018-03-20End: 2023-10-18Updated: 2024-02-01

Phase 2

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

RecruitingNCT01042379

QuantumLeap Healthcare CollaborativeAngiosarcoma, Breast Cancer, Breast Neoplasms +8

Start: 2010-03-01End: 2031-12-01Target: 5000Updated: 2026-03-13

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

Active, not recruitingNCT04829604

Ambrx, Inc.HER2 Positive Metastatic Breast Cancer

Start: 2021-10-26End: 2027-06-01Updated: 2026-03-09

ARX788 in Breast Cancer With Low Expression of HER2

Fudan UniversityBreast Cancer With Low Expression of HER2

Start: 2021-10-20End: 2023-06-30Target: 54Updated: 2022-04-25

ARX788 in HER2-positive Breast Cancer Patients With Brain Metastases

Fudan UniversityHER2-positive, Metastatic Breast Cancer

Start: 2021-07-14End: 2023-06-30Target: 32Updated: 2022-06-01

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

WithdrawnNCT05041972

Ambrx, Inc.HER2 Amplified Solid Tumors, HER2 Mutation-Related Tumors

Start: 2021-11-05End: 2022-04-20Updated: 2022-09-13

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 recruitingNCT05426486

Caigang LiuHER2-positive Breast Cancer

Start: 2022-05-23End: 2028-12-30Target: 136Updated: 2024-10-30

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

Not yet recruitingNCT06224673

Laura Huppert, MD, BAHER2 Low Breast Carcinoma, Hormone-receptor-positive Breast Cancer, Hormone Receptor Positive Breast Carcinoma +1

Start: 2026-03-01End: 2029-06-30Target: 36Updated: 2026-02-13

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

Not yet recruitingNCT06578286

Fudan UniversityBreast Cancer

Start: 2024-09-30End: 2030-09-30Target: 44Updated: 2024-08-29

ARX788 in HER2-positive Metastatic Breast Cancer Patients

Not yet recruitingNCT06663748

Henan Cancer HospitalHER2-positive, Metastatic Breast Cancer

Start: 2024-11-20End: 2029-11-20Target: 44Updated: 2024-10-29

Related Papers

Longitudinal DCE MRI Vascular Textures: Radiologic and Biologic Insights for pCR Prediction in HER2-Negative Breast Cancer.

2026-03-25

Abstract PS3-11-10: Neoadjuvant HSP90 inhibition with ganetespib significantly improves distant relapse-free survival in I-SPY2 patients with HER2-negative breast cancer with low expression of immune genes and no DNA repair deficiency

Clinical Cancer Research2026-02-17

Abstract PS1-01-09: Real-time monitoring for drug-induced interstitial lung disease with Trastuzumab Deruxtecan and Rilvegostomig combination therapy prevents persistent, symptomatic disease: Safety insights from the I-SPY2.2 platform trial

Clinical Cancer Research2026-02-17

Abstract RF5-06: Pathologic complete response rates (pCR) after the novel HER2 ADC ARX788: Results from the I-SPY2.2 trial

Clinical Cancer Research2026-02-17

Abstract PS2-11-06: Quiescent-like phenotype characterizes treatment-resistant early-stage HER2-negative breast cancers and suggests novel therapeutic targets; analysis of over 2000 patients from the I-SPY2 trial

Clinical Cancer Research2026-02-17

Abstract PS5-08-11: Trial in Progress: Phase II Open-Label Study of ARX788 (anti-HER2 Antibody Drug Conjugate (ADC)) for Patients with HER2-Low Locally Advanced Unresectable or Metastatic Breast Cancer

Clinical Cancer Research2026-02-17

Efficacy and safety of ARX788 for individuals with HER2-positive breast cancer and brain metastases (ACE-Breast-06): a single-arm, phase 2 trial in China.

2025-10-30

CHFR expression and sensitivity of breast cancer cells to antimitotic agents in vitro and in the I-SPY trial.

2025-10-24

Detection of serum HER2 in patients treated with neratinib or trastuzumab: analysis of the I-SPY Trial

Frontiers in Oncology2025-07-24

A two-stage dual-task learning strategy for early prediction of pathological complete response to neoadjuvant chemotherapy for breast cancer using dynamic contrast-enhanced magnetic resonance images

Physics in Medicine and Biology2025-07-101 citations

Radiomics-based Machine Learning Prediction of Neoadjuvant Chemotherapy Response in Breast Cancer Using Physiologically Decomposed Diffusion-weighted MRI.

2025-07-012 citations

Neoadjuvant ARX788 plus pyrotinib versus trastuzumab, pertuzumab, docetaxel and carboplatin for HER2-positive breast cancer: a randomised phase 2b trial.

2025-07-012 citations

Combined prognostic impact of initial clinical stage and residual cancer burden after neoadjuvant systemic therapy in triple-negative and HER2-positive breast cancer: an analysis of the I-SPY2 randomized clinical trial

Breast Cancer Research2025-06-233 citations

Abstract P2-10-20: ACE-BREAST-03: A phase 2 trial evaluating ARX788, an anti-HER2 antibody drug conjugate (ADC), for the treatment of HER2+ metastatic breast cancer (mBC) in patients who have been previously treated with trastuzumab deruxtecan (T-DXd)

Clinical Cancer Research2025-06-13

Abstract P2-01-23: A 140-gene Machine Learning Classifier Predicts Survival and Response to Chemotherapy and Immunotherapy in 2500 TNBC

Clinical Cancer Research2025-06-13

Circulating tumor DNA (ctDNA) in patients with stage 2/3 HR+HER2-negative breast cancer (BC) treated with neoadjuvant endocrine therapy (NET) in the I-SPY2 endocrine optimization pilot (EOP) trial.

Journal of Clinical Oncology2025-05-283 citations

Serum estradiol (sE2) levels in premenopausal (PreM) women receiving neoadjuvant ovarian function suppression (OFS) with the oral SERD amcenestrant, alone, or in combination with letrozole or abemaciclib in the I-SPY2 Endocrine Optimization Pilot (EOP).

Journal of Clinical Oncology2025-05-28

I-SPY2 endocrine optimization pilot (EOP): Neoadjuvant lasofoxifene (Laso) in molecularly selected patients with hormone receptor positive (HR+)/HER2 negative (HER2-) stage 2/3 breast cancer (BC).

Journal of Clinical Oncology2025-05-28

Early adverse symptoms to predict response to treatment among patients in the I-SPY trial.

Journal of Clinical Oncology2025-05-28

Causal analyses of the impact of comorbid conditions and concomitant medications on response to neoadjuvant chemotherapy in breast cancer: analysis of a multicenter prospective cohort study (CANTO).

2025-05-15

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