anvatabart opadotin (JNJ-0683) / J&J 
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 0 Diseases   18 Trials   18 Trials   164 News 
19 Trials

   

 
Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
anvatabart opadotin (JNJ-0683) / J&J
ACE-Gastric-02, CTR20211583: Study on the efficacy and safety of ARX788 in patients with HER2-positive advanced gastric cancer and gastroesophageal junction adenocarcinoma

Recruiting
3
765
China
anvatabart opadotin (ARX788) - Ambrx, irinotecan - Generic mfg., docetaxel - Generic mfg.
Zhejiang Xinma Biopharmaceutical Co., Ltd./Zhejiang Pharmaceutical Co., Ltd.
HER2-positive advanced gastric cancer and gastroesophageal junction adenocarcinoma
 
 
ACE-Breast-02, CTR20201708: Clinical study evaluating ARX788 in the treatment of HER2-positive advanced breast cancer

Recruiting
2/3
440
China
capecitabine - Generic mfg., lapatinib - Generic mfg., anvatabart opadotin (ARX788) - Ambrx
Zhejiang Pharmaceutical Co., Ltd./Zhejiang Xinma Biopharmaceutical Co., Ltd.
HER2-positive breast cancer
 
 
NCT05426486: 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
2/3
136
RoW
ARX788, Pyrotinib maleate, Trastuzumab, Pertuzumab, Docetaxel, Carboplatin
Caigang Liu, Jiangsu HengRui Medicine Co., Ltd.
HER2-positive Breast Cancer
12/25
12/28
2021-001246-36: A clinical research study to test different doses of a study drug (ARX788), to see which dose is safest and its effectiveness(shrinks tumor size) in patients with advanced cancer. Estudio de investigación clínica para probar diferentes dosis del fármaco del estudio (ARX788), para ver qué dosis es la más segura y su efectividad (redución tamaño del tumor) en pacientes con cáncer avanzado.

Not yet recruiting
2
210
Europe
ARX788, ARX788, Solution for infusion
Ambrx, Inc., Ambrx, Inc.
Metastatic Breast Cancer Resistant or Refractory Cáncer de mama metastásico resistente o refractario, Advanced Cancer that is metastasic Cáncer avanzado metastásico, Diseases [C] - Cancer [C04]
 
 
NCT05018702: ARX788 in HER2-positive Breast Cancer Patients With Brain Metastases

Recruiting
2
32
RoW
ARX788
Fudan University
HER2-positive, Metastatic Breast Cancer
12/22
06/23
NCT05018676: ARX788 in Breast Cancer With Low Expression of HER2

Recruiting
2
54
RoW
ARX788
Fudan University
Breast Cancer With Low Expression of HER2
12/22
06/23
ACE-Pan Tumor-02, NCT05023330: ARX788 in Selected HER2-mutated or HER2-amplified Solid Tumors

Not yet recruiting
2
250
NA
ARX788, antibody drug conjugate (ADC)
Ambrx, Inc.
HER2 Mutation-Related Tumors, HER2 Amplification
11/23
11/24
ACE-Breast-10, NCT06578286: ARX788 in HER2-positive Metastatic Breast Cancer Patients Who Were Previously Treated With T-DXd

Not yet recruiting
2
44
NA
ARX788
Fudan University
Breast Cancer
09/26
09/30
ACE-Breast-09, NCT06663748: ARX788 in HER2-positive Metastatic Breast Cancer Patients

Not yet recruiting
2
44
NA
ARX788
Henan Cancer Hospital
HER2-positive, Metastatic Breast Cancer
11/25
11/29
ACE-BREAST-03, NCT04829604 / 2021-001246-36: ARX788 in HER2-positive, Metastatic Breast Cancer Subjects (ACE-Breast-03)

Recruiting
2
71
Europe, US, RoW
ARX788, antibody drug conjugate (ADC)
Ambrx, Inc., Ambrx, Inc.
HER2 Positive Metastatic Breast Cancer
12/26
06/27
NCT06224673: ARX788 for Treating Patients With HER2-low Locally Advanced Unresectable or Metastatic Breast Cancer

Not yet recruiting
2
36
US
ARX788, Anvatabart Opadotin, Antibody-drug Conjugate ARX788, Anti-Her2 Mab PAF- MMAF Toxin Oxime Conjugate ARX-788, Anti-Her2 ADC, Computed Tomography (CT), CT Scan, PET/CT, Biospecimen Collection, Specimen Collection, Biological Sample Collection, Amiloride, Amiloride Topical Eye Drops
Laura Huppert, MD, BA, Ambrx, Inc.
HER2 Low Breast Carcinoma, Triple Negative Breast Cancer, Hormone-receptor-positive Breast Cancer, Hormone Receptor Positive Breast Carcinoma
10/28
10/28
ChiCTR2100048560: Efficacy and safety of pyrotinib maleate combined with ARX788 neoadjuvant treatment in stage II-III HER2-positive breast cancer patients who have poor outcomes after treatment with trastuzumab and pertuzumab: study protocol for a prospective, single-arm, multi-center, phase II clinical trial

Not yet recruiting
2
30
 
pyrotinib combined with ARX788 neoadjuvant therapy
Shengjing Hospital of China Medical University; Shengjing Hospital of China Medical University, None
Breast cancer
 
 
NCT04983121: Efficacy and Safety of Pyrotinib Maleate Combined With ARX788 Neoadjuvant Treatment in Breast Cancer Patients

Recruiting
2
30
RoW
Next-generation Site-specific human epidermal growth factor receptor 2 (HER2)-targeting Antibody-drug Conjugate (ARX788), pyrotinib maleate
Shengjing Hospital
Breast Neoplasms
08/27
08/27
I-SPY 2, NCT01042379: I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer

Hourglass Jan 2023 - Dec 2023 : From P2 I-SPY 2 trial for invasive breast cancer
Checkmark Presentation of data from I-SPY trial for HR+/HER2- and TNBC breast cancer at SABCS 2022
Dec 2022 - Dec 2022: Presentation of data from I-SPY trial for HR+/HER2- and TNBC breast cancer at SABCS 2022
Checkmark Data from trial evaluating T-DM1+pertuzumab in the adjuvant setting
Nov 2018 - Nov 2018: Data from trial evaluating T-DM1+pertuzumab in the adjuvant setting
More
Recruiting
2
5000
US
Standard Therapy, Paclitaxel (Taxol); Doxorubicin (Adriamycin), AMG 386 with or without Trastuzumab, AMG 386 (Trebananib); (Trastuzumab) Herceptin, AMG 479 (Ganitumab) plus Metformin, Ganitumab, MK-2206 with or without Trastuzumab, (Trastuzumab) Herceptin, AMG 386 and Trastuzumab, AMG 386 (Trebananib); Trastuzumab (Herceptin), T-DM1 and Pertuzumab, T-DM1 (Trastuzumab emtansine); Pertuzumab (Perjeta), Pertuzumab and Trastuzumab, Pertuzumab (Perjeta); Trastuzumab (Herceptin), Ganetespib, ABT-888, Veliparib, Neratinib, PLX3397, Pembrolizumab - 4 cycle, Talazoparib plus Irinotecan, Patritumab and Trastuzumab, Pembrolizumab - 8 cycle, SGN-LIV1A, Durvalumab plus Olaparib, SD-101 + Pembrolizumab, Tucatinib plus trastuzumab and pertuzumab, Cemiplimab, Cemiplimab plus REGN3767, Trilaciclib with or without trastuzumab + pertuzumab, Trilaciclib (G1T28); Pertuzumab (Perjeta); Trastuzumab (Herceptin), SYD985 ([vic-]trastuzumab duocarmazine), Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) + Carboplatin with or without trastuzumab, Oral Paclitaxel + Encequidar (Oraxol); Dostarlimab (TSR-042); Trastuzumab (Herceptin), Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) with or without trastuzumab, Amcenestrant, SAR439859, Amcenestrant + Abemaciclib, Amcenestrant (SAR439859), Abemaciclib (Verzenio), Amcenestrant + Letrozole, Amcenestrant (SAR439859), Letrozole (Femara), ARX788, ARX788 + Cemiplimab, VV1 + Cemiplimab, VOYAGER V1™, VSV-IFNβ-NIS, Datopotamab deruxtecan, Dato-DXd, Datopotamab deruxtecan + Durvalumab, Zanidatamab, Lasofoxifene, Z-endoxifen, ARV-471, ARV-471 + Letrozole, ARV-471 + Abemaciclib, Endoxifen + Abemaciclib, Rilvegostomig + TDXd, Dan222 + Niraparib, Sarilumab + Cemiplimab + Paclitaxel, GSK 5733584, GSK 5733584 + Dostarlimab
QuantumLeap Healthcare Collaborative
Breast Neoplasms, Breast Cancer, Breast Tumors, Angiosarcoma, TNBC - Triple-Negative Breast Cancer, HER2-positive Breast Cancer, HER2-negative Breast Cancer, Hormone Receptor Positive Tumor, Hormone Receptor Negative Tumor, Early-stage Breast Cancer, Locally Advanced Breast Cancer
12/30
12/31
CTR20211816: Study on the efficacy and safety of ARX788 in patients with HER2-positive advanced solid tumors

Recruiting
1b/2
85
China
anvatabart opadotin (ARX788) - Ambrx
Zhejiang Pharmaceutical Co., Ltd.
HER2-positive advanced solid tumors
 
 
CTR20171162: Phase Ia trial of recombinant humanized anti-HER2 monoclonal antibody-AS269 conjugated injection

Recruiting
1a
21
China
anvatabart opadotin (ARX788) - Ambrx
Zhejiang Pharmaceutical Co., Ltd.
HER2-positive breast cancer
 
 
ACE-COMBO-02, CTR20222247: A Phase I clinical study to evaluate the efficacy and safety of recombinant humanized anti-HER2 monoclonal anti-AS269 conjugate (ARX788) in combination with toripalimab in patients with HER2-expressing or mutated advanced solid tumors

Recruiting
1
85
China
anvatabart opadotin (ARX788) - Ambrx, Loqtorzi (toripalimab) - Shanghai Junshi Biosci, Coherus Biosci
Zhejiang Xinma Biopharmaceutical Co., Ltd
HER2-expressing or mutated advanced solid tumors
 
 
ZMC-ARX788-112, CTR20190639: A single-arm, unblinded, safety and efficacy phase I clinical study of ARX788 in patients with HER2-positive advanced metastatic gastric cancer and gastroesophageal junction adenocarcinoma

Completed
1
90
China
anvatabart opadotin (ARX788) - Ambrx
Zhejiang Pharmaceutical Co., Ltd
HER2-positive advanced gastric cancer
 
 
ACE-Pan Tumor 01, NCT03255070: A Dose-escalation, Expansion Study of ARX788, in Advanced Solid Tumors Subjects With HER2 Expression

Completed
1
106
US, RoW
ARX788, antibody drug conjugate (ADC)
Ambrx, Inc.
Breast Neoplasms, Gastric Neoplasm, Solid Tumors
09/23
10/23
Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
anvatabart opadotin (JNJ-0683) / J&J
ACE-Gastric-02, CTR20211583: Study on the efficacy and safety of ARX788 in patients with HER2-positive advanced gastric cancer and gastroesophageal junction adenocarcinoma

Recruiting
3
765
China
anvatabart opadotin (ARX788) - Ambrx, irinotecan - Generic mfg., docetaxel - Generic mfg.
Zhejiang Xinma Biopharmaceutical Co., Ltd./Zhejiang Pharmaceutical Co., Ltd.
HER2-positive advanced gastric cancer and gastroesophageal junction adenocarcinoma
 
 
ACE-Breast-02, CTR20201708: Clinical study evaluating ARX788 in the treatment of HER2-positive advanced breast cancer

Recruiting
2/3
440
China
capecitabine - Generic mfg., lapatinib - Generic mfg., anvatabart opadotin (ARX788) - Ambrx
Zhejiang Pharmaceutical Co., Ltd./Zhejiang Xinma Biopharmaceutical Co., Ltd.
HER2-positive breast cancer
 
 
NCT05426486: 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
2/3
136
RoW
ARX788, Pyrotinib maleate, Trastuzumab, Pertuzumab, Docetaxel, Carboplatin
Caigang Liu, Jiangsu HengRui Medicine Co., Ltd.
HER2-positive Breast Cancer
12/25
12/28
2021-001246-36: A clinical research study to test different doses of a study drug (ARX788), to see which dose is safest and its effectiveness(shrinks tumor size) in patients with advanced cancer. Estudio de investigación clínica para probar diferentes dosis del fármaco del estudio (ARX788), para ver qué dosis es la más segura y su efectividad (redución tamaño del tumor) en pacientes con cáncer avanzado.

Not yet recruiting
2
210
Europe
ARX788, ARX788, Solution for infusion
Ambrx, Inc., Ambrx, Inc.
Metastatic Breast Cancer Resistant or Refractory Cáncer de mama metastásico resistente o refractario, Advanced Cancer that is metastasic Cáncer avanzado metastásico, Diseases [C] - Cancer [C04]
 
 
NCT05018702: ARX788 in HER2-positive Breast Cancer Patients With Brain Metastases

Recruiting
2
32
RoW
ARX788
Fudan University
HER2-positive, Metastatic Breast Cancer
12/22
06/23
NCT05018676: ARX788 in Breast Cancer With Low Expression of HER2

Recruiting
2
54
RoW
ARX788
Fudan University
Breast Cancer With Low Expression of HER2
12/22
06/23
ACE-Pan Tumor-02, NCT05023330: ARX788 in Selected HER2-mutated or HER2-amplified Solid Tumors

Not yet recruiting
2
250
NA
ARX788, antibody drug conjugate (ADC)
Ambrx, Inc.
HER2 Mutation-Related Tumors, HER2 Amplification
11/23
11/24
ACE-Breast-10, NCT06578286: ARX788 in HER2-positive Metastatic Breast Cancer Patients Who Were Previously Treated With T-DXd

Not yet recruiting
2
44
NA
ARX788
Fudan University
Breast Cancer
09/26
09/30
ACE-Breast-09, NCT06663748: ARX788 in HER2-positive Metastatic Breast Cancer Patients

Not yet recruiting
2
44
NA
ARX788
Henan Cancer Hospital
HER2-positive, Metastatic Breast Cancer
11/25
11/29
ACE-BREAST-03, NCT04829604 / 2021-001246-36: ARX788 in HER2-positive, Metastatic Breast Cancer Subjects (ACE-Breast-03)

Recruiting
2
71
Europe, US, RoW
ARX788, antibody drug conjugate (ADC)
Ambrx, Inc., Ambrx, Inc.
HER2 Positive Metastatic Breast Cancer
12/26
06/27
NCT06224673: ARX788 for Treating Patients With HER2-low Locally Advanced Unresectable or Metastatic Breast Cancer

Not yet recruiting
2
36
US
ARX788, Anvatabart Opadotin, Antibody-drug Conjugate ARX788, Anti-Her2 Mab PAF- MMAF Toxin Oxime Conjugate ARX-788, Anti-Her2 ADC, Computed Tomography (CT), CT Scan, PET/CT, Biospecimen Collection, Specimen Collection, Biological Sample Collection, Amiloride, Amiloride Topical Eye Drops
Laura Huppert, MD, BA, Ambrx, Inc.
HER2 Low Breast Carcinoma, Triple Negative Breast Cancer, Hormone-receptor-positive Breast Cancer, Hormone Receptor Positive Breast Carcinoma
10/28
10/28
ChiCTR2100048560: Efficacy and safety of pyrotinib maleate combined with ARX788 neoadjuvant treatment in stage II-III HER2-positive breast cancer patients who have poor outcomes after treatment with trastuzumab and pertuzumab: study protocol for a prospective, single-arm, multi-center, phase II clinical trial

Not yet recruiting
2
30
 
pyrotinib combined with ARX788 neoadjuvant therapy
Shengjing Hospital of China Medical University; Shengjing Hospital of China Medical University, None
Breast cancer
 
 
NCT04983121: Efficacy and Safety of Pyrotinib Maleate Combined With ARX788 Neoadjuvant Treatment in Breast Cancer Patients

Recruiting
2
30
RoW
Next-generation Site-specific human epidermal growth factor receptor 2 (HER2)-targeting Antibody-drug Conjugate (ARX788), pyrotinib maleate
Shengjing Hospital
Breast Neoplasms
08/27
08/27
I-SPY 2, NCT01042379: I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer

Hourglass Jan 2023 - Dec 2023 : From P2 I-SPY 2 trial for invasive breast cancer
Checkmark Presentation of data from I-SPY trial for HR+/HER2- and TNBC breast cancer at SABCS 2022
Dec 2022 - Dec 2022: Presentation of data from I-SPY trial for HR+/HER2- and TNBC breast cancer at SABCS 2022
Checkmark Data from trial evaluating T-DM1+pertuzumab in the adjuvant setting
Nov 2018 - Nov 2018: Data from trial evaluating T-DM1+pertuzumab in the adjuvant setting
More
Recruiting
2
5000
US
Standard Therapy, Paclitaxel (Taxol); Doxorubicin (Adriamycin), AMG 386 with or without Trastuzumab, AMG 386 (Trebananib); (Trastuzumab) Herceptin, AMG 479 (Ganitumab) plus Metformin, Ganitumab, MK-2206 with or without Trastuzumab, (Trastuzumab) Herceptin, AMG 386 and Trastuzumab, AMG 386 (Trebananib); Trastuzumab (Herceptin), T-DM1 and Pertuzumab, T-DM1 (Trastuzumab emtansine); Pertuzumab (Perjeta), Pertuzumab and Trastuzumab, Pertuzumab (Perjeta); Trastuzumab (Herceptin), Ganetespib, ABT-888, Veliparib, Neratinib, PLX3397, Pembrolizumab - 4 cycle, Talazoparib plus Irinotecan, Patritumab and Trastuzumab, Pembrolizumab - 8 cycle, SGN-LIV1A, Durvalumab plus Olaparib, SD-101 + Pembrolizumab, Tucatinib plus trastuzumab and pertuzumab, Cemiplimab, Cemiplimab plus REGN3767, Trilaciclib with or without trastuzumab + pertuzumab, Trilaciclib (G1T28); Pertuzumab (Perjeta); Trastuzumab (Herceptin), SYD985 ([vic-]trastuzumab duocarmazine), Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) + Carboplatin with or without trastuzumab, Oral Paclitaxel + Encequidar (Oraxol); Dostarlimab (TSR-042); Trastuzumab (Herceptin), Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) with or without trastuzumab, Amcenestrant, SAR439859, Amcenestrant + Abemaciclib, Amcenestrant (SAR439859), Abemaciclib (Verzenio), Amcenestrant + Letrozole, Amcenestrant (SAR439859), Letrozole (Femara), ARX788, ARX788 + Cemiplimab, VV1 + Cemiplimab, VOYAGER V1™, VSV-IFNβ-NIS, Datopotamab deruxtecan, Dato-DXd, Datopotamab deruxtecan + Durvalumab, Zanidatamab, Lasofoxifene, Z-endoxifen, ARV-471, ARV-471 + Letrozole, ARV-471 + Abemaciclib, Endoxifen + Abemaciclib, Rilvegostomig + TDXd, Dan222 + Niraparib, Sarilumab + Cemiplimab + Paclitaxel, GSK 5733584, GSK 5733584 + Dostarlimab
QuantumLeap Healthcare Collaborative
Breast Neoplasms, Breast Cancer, Breast Tumors, Angiosarcoma, TNBC - Triple-Negative Breast Cancer, HER2-positive Breast Cancer, HER2-negative Breast Cancer, Hormone Receptor Positive Tumor, Hormone Receptor Negative Tumor, Early-stage Breast Cancer, Locally Advanced Breast Cancer
12/30
12/31
CTR20211816: Study on the efficacy and safety of ARX788 in patients with HER2-positive advanced solid tumors

Recruiting
1b/2
85
China
anvatabart opadotin (ARX788) - Ambrx
Zhejiang Pharmaceutical Co., Ltd.
HER2-positive advanced solid tumors
 
 
CTR20171162: Phase Ia trial of recombinant humanized anti-HER2 monoclonal antibody-AS269 conjugated injection

Recruiting
1a
21
China
anvatabart opadotin (ARX788) - Ambrx
Zhejiang Pharmaceutical Co., Ltd.
HER2-positive breast cancer
 
 
ACE-COMBO-02, CTR20222247: A Phase I clinical study to evaluate the efficacy and safety of recombinant humanized anti-HER2 monoclonal anti-AS269 conjugate (ARX788) in combination with toripalimab in patients with HER2-expressing or mutated advanced solid tumors

Recruiting
1
85
China
anvatabart opadotin (ARX788) - Ambrx, Loqtorzi (toripalimab) - Shanghai Junshi Biosci, Coherus Biosci
Zhejiang Xinma Biopharmaceutical Co., Ltd
HER2-expressing or mutated advanced solid tumors
 
 
ZMC-ARX788-112, CTR20190639: A single-arm, unblinded, safety and efficacy phase I clinical study of ARX788 in patients with HER2-positive advanced metastatic gastric cancer and gastroesophageal junction adenocarcinoma

Completed
1
90
China
anvatabart opadotin (ARX788) - Ambrx
Zhejiang Pharmaceutical Co., Ltd
HER2-positive advanced gastric cancer
 
 
ACE-Pan Tumor 01, NCT03255070: A Dose-escalation, Expansion Study of ARX788, in Advanced Solid Tumors Subjects With HER2 Expression

Completed
1
106
US, RoW
ARX788, antibody drug conjugate (ADC)
Ambrx, Inc.
Breast Neoplasms, Gastric Neoplasm, Solid Tumors
09/23
10/23

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