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DRUG CLASS:
HER3 inhibitor
DRUG CLASS:
HER3 inhibitor
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News alerts, weekly reports and conference planners
Related drugs:
‹
zenocutuzumab-zbco (16)
MM-121 (12)
Ac-225 ErbB3 targeted radiotherapy (4)
ISU104 (4)
AV-203 (1)
LJM-716 (1)
SI-B001 (1)
U3-1287 (1)
177Lu-HER3 ARC (0)
CDX-3379 (0)
GSK2849330 (0)
MM 111 (0)
Sym013 (0)
INCB7839 (0)
MEHD7945A (0)
MM-141 (0)
RG7116 (0)
AZD8931 (0)
zenocutuzumab-zbco (16)
MM-121 (12)
Ac-225 ErbB3 targeted radiotherapy (4)
ISU104 (4)
AV-203 (1)
LJM-716 (1)
SI-B001 (1)
U3-1287 (1)
177Lu-HER3 ARC (0)
CDX-3379 (0)
GSK2849330 (0)
MM 111 (0)
Sym013 (0)
INCB7839 (0)
MEHD7945A (0)
MM-141 (0)
RG7116 (0)
AZD8931 (0)
›
Associations
(40)
News
Trials
Phase
Status
Apply
Phase
Status
Apply
INCB7839 in Treating Children With Recurrent/Progressive High-Grade Gliomas (NCT04295759)
Phase 1
Pediatric Brain Tumor Consortium
Pediatric Brain Tumor Consortium
Completed
Phase 1
Pediatric Brain Tumor Consortium
Completed
Last update posted :
02/19/2025
Initiation :
07/27/2020
Primary completion :
12/31/2023
Completion :
12/01/2024
HER-2 • CD4 • ADAM10
|
aderbasib (INCB7839)
A Clinical Study of SI-B001 Combined With Docetaxel in the Treatment of Non-small Cell Lung Adenocarcinoma and Lung Squamous Cell Carcinoma (NCT05943795)
Phase 3
Sichuan Baili Pharmaceutical Co., Ltd.
Sichuan Baili Pharmaceutical Co., Ltd.
Recruiting
Phase 3
Sichuan Baili Pharmaceutical Co., Ltd.
Recruiting
Last update posted :
02/11/2025
Initiation :
07/14/2023
Primary completion :
07/01/2026
Completion :
07/01/2026
EGFR • HER-2 • KRAS • BRAF • ALK • ROS1 • NTRK
|
KRAS mutation • KRAS G12C • BRAF mutation • HER-2 amplification • BRAF V600 • KRAS G12D • EGFR wild-type • RET mutation • ALK wild-type • ROS1 fusion • ROS1 rearrangement • RET rearrangement • KRAS G12 • KRAS amplification • NTRK fusion
|
docetaxel • izalontamab (SI-B001)
Early Access Program Providing HER2/HER3 Bispecific Antibody, MCLA-128, for a Patient With Advanced NRG1-Fusion Positive Solid Tumor (NCT04100694)
Phase N/A
Merus N.V.
Merus N.V.
Available
Phase N/A
Merus N.V.
Available
Last update posted :
02/05/2025
NRG1
|
NRG1 fusion
|
Bizengri (zenocutuzumab-zbco)
Study Evaluating Zenocutuzumab in Patients With or Without Molecularly Defined Cancers (NCT05588609)
Phase 2
Merus N.V.
Merus N.V.
Active, not recruiting
Phase 2
Merus N.V.
Active, not recruiting
Last update posted :
02/04/2025
Initiation :
11/17/2022
Primary completion :
10/01/2025
Completion :
03/01/2026
NRG1
|
NRG1 fusion
|
Gilotrif (afatinib) • Xtandi (enzalutamide) • abiraterone acetate • Bizengri (zenocutuzumab-zbco)
A Study of Zenocutuzumab (MCLA-128) in Patients With Solid Tumors Harboring an NRG1 Fusion (eNRGy) (NCT02912949)
Phase 2
Merus N.V.
Merus N.V.
Active, not recruiting
Phase 2
Merus N.V.
Active, not recruiting
Last update posted :
02/03/2025
Initiation :
01/01/2015
Primary completion :
12/31/2026
Completion :
12/31/2026
NRG1
|
NRG1 fusion
|
Bizengri (zenocutuzumab-zbco)
Clinical Study of SI-B001+SI-B003± Chemotherapy in Patients With Locally Advanced or Metastatic Head and Neck Squamous Cell Carcinoma (NCT05668858)
Phase 1/2
Sichuan Baili Pharmaceutical Co., Ltd.
Sichuan Baili Pharmaceutical Co., Ltd.
Recruiting
Phase 1/2
Sichuan Baili Pharmaceutical Co., Ltd.
Recruiting
Last update posted :
04/04/2024
Initiation :
02/10/2023
Primary completion :
12/01/2024
Completion :
12/01/2024
PD-L1
|
carboplatin • izalontamab (SI-B001) • danvilostomig (SI-B003)
SI-B001 Combined With Chemotherapy in the Treatment of EGFR/ALK WT Recurrent or Metastatic NSCLC. (NCT05020457)
Phase 2
Sichuan Baili Pharmaceutical Co., Ltd.
Sichuan Baili Pharmaceutical Co., Ltd.
Recruiting
Phase 2
Sichuan Baili Pharmaceutical Co., Ltd.
Recruiting
Last update posted :
01/31/2024
Initiation :
12/07/2021
Primary completion :
04/01/2024
Completion :
04/01/2024
EGFR • ALK
|
EGFR wild-type • ALK wild-type • EGFR wild-type + ALK wild-type
|
cisplatin • Tagrisso (osimertinib) • paclitaxel • docetaxel • pemetrexed • izalontamab (SI-B001)
A Phase Ⅰa Clinical Study Exploring Efficacy of SIBP-03 When Treating the Patients With Advanced Malignant Solid Tumors. (NCT05203601)
Phase 1
Shanghai Institute Of Biological Products
Shanghai Institute Of Biological Products
Completed
Phase 1
Shanghai Institute Of Biological Products
Completed
Last update posted :
12/27/2023
Initiation :
11/26/2020
Primary completion :
12/06/2022
Completion :
12/06/2022
EGFR • HER-2 • TP53 • PIK3CA • ERBB3 • NOTCH1 • NRG1 • NOTCH2 • FAT1 • NOTCH4
|
HER-2 overexpression
|
docetaxel
A Study of SI-B001+SI-B003± Chemotherapy in the Treatment of Locally Advanced or Metastatic Non-small Cell Lung Cancer (NCT05949606)
Phase 1/2
Sichuan Baili Pharmaceutical Co., Ltd.
Sichuan Baili Pharmaceutical Co., Ltd.
Recruiting
Phase 1/2
Sichuan Baili Pharmaceutical Co., Ltd.
Recruiting
Last update posted :
11/29/2023
Initiation :
10/30/2023
Primary completion :
11/01/2025
Completion :
11/01/2025
HER-2 • KRAS • BRAF • ALK • MET • ROS1 • NTRK
|
BRAF mutation • BRAF V600 • EGFR wild-type • MET exon 14 mutation • ALK fusion • RET mutation • ROS1 fusion • ROS1 rearrangement • RET rearrangement • NTRK fusion
|
izalontamab (SI-B001) • danvilostomig (SI-B003)
Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors (CRESTONE) (NCT04383210)
Phase 2
Elevation Oncology
Elevation Oncology
Active, not recruiting
Phase 2
Elevation Oncology
Active, not recruiting
Last update posted :
08/08/2023
Initiation :
09/29/2020
Primary completion :
01/01/2025
Completion :
03/01/2025
NRG1
|
NRG1 fusion
|
seribantumab (MM-121)
Open-Label Study Evaluating the Safety and Tolerability of LJM716, BYL719 and Trastuzumab in Patients With Metastatic HER2+ Breast Cancer (NCT02167854)
Phase 1
Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center
Completed
Phase 1
Memorial Sloan Kettering Cancer Center
Completed
Last update posted :
07/09/2021
Initiation :
06/16/2014
Primary completion :
07/07/2021
Completion :
07/07/2021
HER-2 • PIK3CA
|
HER-2 amplification • PIK3CA mutation
|
Herceptin (trastuzumab) • Piqray (alpelisib) • elgemtumab (LJM-716)
Study of Erlotinib With or Without Investigational Drug (U3-1287) in Subjects With Advanced Non-small Cell Lung Cancer (NCT01211483)
Phase 1b/2
Daiichi Sankyo, Inc.
Daiichi Sankyo, Inc.
Completed
Phase 1b/2
Daiichi Sankyo, Inc.
Completed
Last update posted :
06/16/2021
Initiation :
09/01/2010
Primary completion :
10/01/2013
Completion :
11/23/2013
KEAP1 • NRG1
|
erlotinib • patritumab (U3-1287)
A Phase I Study of LJM716 in Squamous Cell Carcinoma of Head and Neck, or HER2+ Breast Cancer or Gastric Cancer (NCT01598077)
Phase 1
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Completed
Phase 1
Novartis Pharmaceuticals
Completed
Last update posted :
12/19/2020
Initiation :
07/01/2012
Primary completion :
03/01/2014
Completion :
03/01/2014
HER-2
|
elgemtumab (LJM-716)
A Phase I Study of LJM716 in Japanese Patients With Advanced Solid Tumors (NCT01911936)
Phase 1
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Completed
Phase 1
Novartis Pharmaceuticals
Completed
Last update posted :
12/17/2020
Initiation :
09/01/2013
Primary completion :
03/01/2015
Completion :
03/01/2015
HER-2
|
HER-2 overexpression
|
elgemtumab (LJM-716)
A Window of Opportunity Study of KTN3379 in Surgically Resectable Head and Neck Cancer Patients (NCT02473731)
Phase 1
Celldex Therapeutics
Celldex Therapeutics
Completed
Phase 1
Celldex Therapeutics
Completed
Last update posted :
08/01/2019
Initiation :
10/01/2015
Primary completion :
09/22/2016
Completion :
10/10/2016
ERBB3
|
CDX-3379
Dose Escalation Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of GSK2849330 in Subjects With Advanced Her3-Positive Solid Tumors (NCT01966445)
Phase 1
GlaxoSmithKline
GlaxoSmithKline
Completed
Phase 1
GlaxoSmithKline
Completed
Last update posted :
07/01/2019
Initiation :
11/26/2013
Primary completion :
09/18/2017
Completion :
09/18/2017
ERBB3 • CA 19-9
|
GSK2849330
Immuno Positron Emission Tomography Study of GSK2849330 in Subjects With Human Epidermal Growth Factor Receptor 3-Positive Solid Tumors (NCT02345174)
Phase 1
GlaxoSmithKline
GlaxoSmithKline
Completed
Phase 1
GlaxoSmithKline
Completed
Last update posted :
02/21/2019
Initiation :
03/19/2015
Primary completion :
06/02/2016
Completion :
06/02/2016
ERBB3
|
ERBB3 expression
|
GSK2849330
A Phase 2 Study of MM-141 Plus Nab-paclitaxel and Gemcitabine in Front-line Metastatic Pancreatic Cancer (CARRIE) (NCT02399137)
Phase 2
Merrimack Pharmaceuticals
Merrimack Pharmaceuticals
Completed
Phase 2
Merrimack Pharmaceuticals
Completed
Last update posted :
09/18/2018
Initiation :
05/01/2015
Primary completion :
08/01/2018
Completion :
08/01/2018
IGF1
|
gemcitabine • albumin-bound paclitaxel • istiratumab (MM-141)
Open-Label Study to Assess the Safety/Tolerability in Patients With Solid Tumors (NCT00820560)
Phase 1
Incyte Corporation
Incyte Corporation
Completed
Phase 1
Incyte Corporation
Completed
Last update posted :
01/17/2018
Initiation :
01/01/2005
Primary completion :
01/01/2009
Completion :
01/01/2009
HER-2
|
aderbasib (INCB7839)
A Study to Evaluate Lumretuzumab in Combination With Pertuzumab and Paclitaxel in Participants With Metastatic Breast Cancer Expressing Human Epidermal Growth Factor Receptor (HER) 3 and HER2 Protein (NCT01918254)
Phase 1
Hoffmann-La Roche
Hoffmann-La Roche
Completed
Phase 1
Hoffmann-La Roche
Completed
Last update posted :
09/12/2017
Initiation :
08/06/2013
Primary completion :
10/07/2016
Completion :
10/07/2016
HER-2 • ERBB3
|
HER-2 expression
|
paclitaxel • Perjeta (pertuzumab) • lumretuzumab (RG7116)
A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of KTN3379 in Adult Subjects With Advanced Tumors (NCT02014909)
Phase 1
Celldex Therapeutics
Celldex Therapeutics
Completed
Phase 1
Celldex Therapeutics
Completed
Last update posted :
07/24/2017
Initiation :
01/01/2014
Primary completion :
05/25/2017
Completion :
06/05/2017
EGFR • HER-2 • KRAS • BRAF
|
HER-2 positive • BRAF V600E • BRAF V600 • EGFR expression • EGFR wild-type • RAS wild-type
|
CDX-3379
A Study of RO5479599 Alone or in Combination With Cetuximab or Erlotinib in Participants With Metastatic and/or Locally Advanced Malignant Human Epidermal Growth Factor Receptor (HER3) Expressing Solid Tumors of Epithelial Cell Origin (NCT01482377)
Phase 1a/1b
Hoffmann-La Roche
Hoffmann-La Roche
Completed
Phase 1a/1b
Hoffmann-La Roche
Completed
Last update posted :
01/27/2017
Initiation :
12/01/2011
Primary completion :
02/01/2016
Completion :
02/01/2016
EGFR • ERBB3
|
EGFR expression • ERBB3 expression • EGFR positive
|
Erbitux (cetuximab) • erlotinib • lumretuzumab (RG7116)
Safety and Efficacy Study of MEHD7945A + FOLFIRI Versus Cetuximab + FOLFIRI as Second Line Therapy in Participants With KRAS Wild-Type Metastatic Colorectal Cancer (mCRC) (NCT01652482)
Phase 2
Genentech, Inc.
Genentech, Inc.
Completed
Phase 2
Genentech, Inc.
Completed
Last update posted :
11/02/2016
Initiation :
10/01/2012
Primary completion :
11/01/2014
Completion :
11/01/2014
KRAS
|
KRAS wild-type • RAS wild-type
|
Erbitux (cetuximab) • 5-fluorouracil • irinotecan • leucovorin calcium • duligotuzumab (MEHD7945A)
A Study of MM-121 in Combination With Paclitaxel in Patients With Advanced Gynecologic and Breast Cancers (NCT01209195)
Phase 1
Merrimack Pharmaceuticals
Merrimack Pharmaceuticals
Completed
Phase 1
Merrimack Pharmaceuticals
Completed
Last update posted :
09/08/2016
Initiation :
10/01/2010
Primary completion :
05/01/2014
Completion :
07/01/2014
HER-2
|
HER-2 overexpression
|
paclitaxel • seribantumab (MM-121)
Phase I Safety Study of the Drug MM-121 in Patients With Advanced Solid Tumors Resisting Ordinary Treatment (NCT00734305)
Phase 1
Merrimack Pharmaceuticals
Merrimack Pharmaceuticals
Completed
Phase 1
Merrimack Pharmaceuticals
Completed
Last update posted :
09/01/2016
Initiation :
07/01/2008
Primary completion :
05/01/2010
Completion :
09/01/2013
HER-2 • PGR
|
seribantumab (MM-121)
A Study of MEHD7945A and Cobimetinib in Patients With Locally Advanced or Metastatic Cancers With Mutant KRAS (NCT01986166)
Phase 1
Genentech, Inc.
Genentech, Inc.
Completed
Phase 1
Genentech, Inc.
Completed
Last update posted :
07/18/2016
Initiation :
11/01/2013
Primary completion :
01/01/2016
Completion :
01/01/2016
KRAS
|
KRAS mutation
|
Cotellic (cobimetinib) • duligotuzumab (MEHD7945A)
Trial of Exemestane +/- MM-121 in Postmenopausal Women With Locally Advanced or Metastatic Estrogen Receptor Positive and/or Progesterone Receptor Positive Her2 Negative Breast Cancer (NCT01151046)
Phase 2
Merrimack Pharmaceuticals
Merrimack Pharmaceuticals
Completed
Phase 2
Merrimack Pharmaceuticals
Completed
Last update posted :
05/12/2016
Initiation :
06/01/2010
Primary completion :
06/01/2014
Completion :
09/01/2014
HER-2
|
HER-2 negative
|
exemestane • seribantumab (MM-121)
A Trial of Preoperative MM-121 With Paclitaxel in HER2-negative Breast Cancer (NCT01421472)
Phase 2
Merrimack Pharmaceuticals
Merrimack Pharmaceuticals
Completed
Phase 2
Merrimack Pharmaceuticals
Completed
Last update posted :
05/03/2016
Initiation :
08/01/2011
Primary completion :
12/01/2013
Completion :
06/01/2014
HER-2 • ER
|
ER positive • HER-2 negative
|
paclitaxel • doxorubicin hydrochloride • cyclophosphamide • seribantumab (MM-121)
Phase I/II AZD8931/Paclitaxel in Treatment of Advanced Solid Tumours (Phase I) and Advanced Breast Cancer (Phase II) (THYME) (NCT00900627)
Phase 2
AstraZeneca
AstraZeneca
Completed
Phase 2
AstraZeneca
Completed
Last update posted :
01/20/2016
Initiation :
06/01/2009
Primary completion :
04/01/2012
Completion :
02/01/2015
HER-2
|
HER-2 expression
|
paclitaxel • sapitinib (AZD8931)
A Study of MM-111 in Combination With Multiple Treatments in Patients With HER2 Positive Cancer (NCT01304784)
Phase 1
Merrimack Pharmaceuticals
Merrimack Pharmaceuticals
Completed
Phase 1
Merrimack Pharmaceuticals
Completed
Last update posted :
12/16/2015
Initiation :
01/01/2011
Primary completion :
04/01/2014
Completion :
06/01/2014
HER-2
|
HER-2 positive
|
Herceptin (trastuzumab) • cisplatin • paclitaxel • docetaxel • lapatinib • capecitabine • MM 111
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