^
3d
INCB7839 in Treating Children With Recurrent/Progressive High-Grade Gliomas (clinicaltrials.gov)
P1, N=13, Active, not recruiting, Pediatric Brain Tumor Consortium | Trial completion date: Jun 2024 --> Mar 2025
Trial completion date
|
HER-2 (Human epidermal growth factor receptor 2) • CD4 (CD4 Molecule) • ADAM10 (ADAM Metallopeptidase Domain 10)
|
aderbasib (INCB7839)
17d
New P2 trial
|
izalontamab (SI-B001) • danvilostomig (SI-B003)
1m
Clinical Trial of SIBP-03 in Patients With Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov)
P2, N=81, Recruiting, Shanghai Institute Of Biological Products | Not yet recruiting --> Recruiting
Enrollment open • Metastases
|
Erbitux (cetuximab)
1m
SI-B001 Combined With Irinotecan in the Treatment of Recurrent Metastatic Esophageal Squamous Cell Carcinoma. (clinicaltrials.gov)
P2, N=40, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Aug 2024 --> Jun 2025 | Trial primary completion date: Aug 2024 --> Jun 2025
Trial completion date • Trial primary completion date • Metastases
|
irinotecan • izalontamab (SI-B001)
1m
A Clinical Study to Evaluate the Efficacy and Safety of SI-B001 in the Treatment of Recurrent and Metastatic HNSCC (clinicaltrials.gov)
P2, N=30, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Aug 2024 --> Jun 2025 | Trial primary completion date: Aug 2024 --> Jun 2025
Trial completion date • Trial primary completion date • Metastases
|
izalontamab (SI-B001)
1m
A Clinical Study of SI-B001 in Combination With Paclitaxel in the Treatment of Recurrent and Metastatic HNSCC (clinicaltrials.gov)
P2, N=30, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Aug 2024 --> Jun 2025 | Trial primary completion date: Aug 2024 --> Jun 2025
Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
paclitaxel • izalontamab (SI-B001)
1m
A Study of SI-B001, an EGFR/HER3 Bispecific Antibody, in Locally Advanced or Metastatic Epithelial Tumors (clinicaltrials.gov)
P1, N=60, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Aug 2024 --> Jun 2025 | Trial primary completion date: Aug 2024 --> Jun 2025
Trial completion date • Trial primary completion date • Metastases
|
izalontamab (SI-B001)
1m
SI-B001 Combined With Osimertinib Mesylate Tablets in the Treatment of Recurrent Metastatic Non-small Cell Lung Cancer. (clinicaltrials.gov)
P2/3, N=14, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Aug 2024 --> Jun 2025 | Trial primary completion date: Aug 2024 --> Jun 2025
Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
EGFR mutation • EGFR T790M negative
|
Tagrisso (osimertinib) • izalontamab (SI-B001)
1m
SI-B001 Combined With Chemotherapy in the Treatment of EGFR/ALK WT Recurrent or Metastatic NSCLC. (clinicaltrials.gov)
P2, N=60, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Aug 2024 --> Jun 2025 | Trial primary completion date: Aug 2024 --> Jun 2025
Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
|
EGFR wild-type • ALK wild-type • EGFR wild-type + ALK wild-type
|
cisplatin • paclitaxel • docetaxel • pemetrexed • izalontamab (SI-B001)
1m
Immune microenvironment modulation following neoadjuvant therapy for oesophageal adenocarcinoma: a translational analysis of the DEBIOC clinical trial. (PubMed, ESMO Open)
OAC may be subdivided into three immune-related subgroups which undergo modulation in response to neoadjuvant therapy with marked suppression of the immune microenvironment in HER2-positive/immune-high tumours.
Journal
|
HER-2 (Human epidermal growth factor receptor 2) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3)
|
HER-2 positive • HER-2 expression • EGFR positive • EGFR negative
|
capecitabine • oxaliplatin • sapitinib (AZD8931)
2ms
Study Evaluating Zenocutuzumab in Patients with or Without Molecularly Defined Cancers (clinicaltrials.gov)
P2, N=90, Active, not recruiting, Merus N.V. | Recruiting --> Active, not recruiting
Enrollment closed
|
NRG1 (Neuregulin 1)
|
NRG1 fusion
|
Gilotrif (afatinib) • Xtandi (enzalutamide capsule) • abiraterone acetate • zenocutuzumab (MCLA-128)
2ms
Copper metabolism-related signature for prognosis prediction and MMP13 served as malignant factor for breast cancer. (PubMed, Heliyon)
Patients with higher CuScores had lower TMB and were more sensitive to Sapitinib and LCL161, while those with lower CuScores might respond better to anti-PD1 therapy. The identified copper metabolism-related gene signature has the potential to predict prognosis and guide clinical treatment for BC. Among these genes, MMP13 may act as a malignant factor in BC.
Journal • PD(L)-1 Biomarker • IO biomarker
|
CEACAM5 (CEA Cell Adhesion Molecule 5) • MAPK1 (Mitogen-activated protein kinase 1) • ATP7A (ATPase Copper Transporting Alpha) • SLC31A1 (Solute Carrier Family 31 Member 1)
|
LCL161 • sapitinib (AZD8931)
2ms
CRESTONE: Study of Seribantumab in Adult Patients with NRG1 Gene Fusion Positive Advanced Solid Tumors (clinicaltrials.gov)
P2, N=54, Terminated, Elevation Oncology | Trial completion date: Mar 2025 --> Feb 2024 | Active, not recruiting --> Terminated | Trial primary completion date: Jan 2025 --> Feb 2024; Business decision
Trial completion date • Trial termination • Trial primary completion date • Metastases
|
NRG1 (Neuregulin 1)
|
NRG1 fusion
|
seribantumab (MM-121)
3ms
Foundation Medicine Collaborates With Merus to Advance Treatment Options in NRG1 Fusion-Driven Tumors Using Foundation Medicine’s RNA Platform (Businesswire)
"Foundation Medicine...announced a collaboration to develop Foundation Medicine’s RNA platform as a companion diagnostic for Merus N.V.’s...bispecific antibody zenocutuzumab (Zeno) to treat patients with neuregulin 1 fusion (NRG1+) cancer. Zeno is a Biclonics that utilizes the Merus Dock & Block mechanism to inhibit the neuregulin/HER3 tumor-signaling pathway in solid tumors with NRG1 fusions (NRG1+ cancer)....'We anticipate this innovative molecular information will help detect more NRG1 fusions and provide healthcare providers with important information to inform their care decisions for patients'."
Licensing / partnership
|
zenocutuzumab (MCLA-128)
3ms
Clinical Trial of SIBP-03 in Patients With Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov)
P2, N=81, Not yet recruiting, Shanghai Institute Of Biological Products | Trial completion date: May 2025 --> Jul 2026 | Initiation date: Dec 2023 --> Aug 2024 | Trial primary completion date: May 2025 --> Jul 2026
Trial completion date • Trial initiation date • Trial primary completion date • Metastases
|
Erbitux (cetuximab)
5ms
SI-B001 Combined With Irinotecan in the Treatment of Recurrent Metastatic Esophageal Squamous Cell Carcinoma. (clinicaltrials.gov)
P2, N=40, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Apr 2024 --> Aug 2024 | Trial primary completion date: Apr 2024 --> Aug 2024
Trial completion date • Trial primary completion date • Metastases
|
irinotecan • izalontamab (SI-B001)
5ms
A Study of SI-B001, an EGFR/HER3 Bispecific Antibody, in Locally Advanced or Metastatic Epithelial Tumors (clinicaltrials.gov)
P1, N=60, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Apr 2024 --> Aug 2024 | Trial primary completion date: Apr 2024 --> Aug 2024
Trial completion date • Trial primary completion date • Metastases
|
izalontamab (SI-B001)
5ms
A Clinical Study to Evaluate the Efficacy and Safety of SI-B001 in the Treatment of Recurrent and Metastatic HNSCC (clinicaltrials.gov)
P2, N=30, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Apr 2024 --> Aug 2024 | Trial primary completion date: Apr 2024 --> Aug 2024
Trial completion date • Trial primary completion date • Metastases
|
izalontamab (SI-B001)
5ms
SI-B001 Combined With Chemotherapy in the Treatment of EGFR/ALK WT Recurrent or Metastatic NSCLC. (clinicaltrials.gov)
P2, N=60, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Apr 2024 --> Aug 2024 | Trial primary completion date: Apr 2024 --> Aug 2024
Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
|
cisplatin • paclitaxel • docetaxel • pemetrexed • izalontamab (SI-B001)
5ms
Targeting FTO suppresses hepatocellular carcinoma by inhibiting ERBB3 and TUBB4A expression. (PubMed, Biochem Pharmacol)
Moreover, FB23-2 disturbed the stability of the tubulin cytoskeleton, whereas overexpression of TUBB4A rescued the migration of HCC cells. Collectively, our study demonstrates that FTO plays a critical role in HCC by maintaining the proliferation and migration of cells and highlights the potential of FTO inhibitors for targeting HCC.
Journal
|
ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3) • FTO (Alpha-Ketoglutarate-Dependent Dioxygenase FTO)
7ms
New P2 trial
9ms
MCLA-128-CL02: MCLA-128 With Trastuzumab/Chemotherapy in HER2+ and With Endocrine Therapy in ER+ and Low HER2 Breast Cancer. (clinicaltrials.gov)
P2, N=105, Completed, Merus N.V. | Active, not recruiting --> Completed | Trial completion date: Feb 2024 --> Jul 2023
Trial completion • Trial completion date • Metastases
|
Herceptin (trastuzumab) • fulvestrant • letrozole • vinorelbine tartrate • anastrozole • zenocutuzumab (MCLA-128) • exemestane
9ms
A Clinical Study to Evaluate the Efficacy and Safety of SI-B001 in the Treatment of Recurrent and Metastatic HNSCC (clinicaltrials.gov)
P2, N=30, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Dec 2023 --> Apr 2024 | Trial primary completion date: Dec 2023 --> Apr 2024
Trial completion date • Trial primary completion date • Metastases
|
izalontamab (SI-B001)
9ms
A Clinical Study of SI-B001 in Combination With Paclitaxel in the Treatment of Recurrent and Metastatic HNSCC (clinicaltrials.gov)
P2, N=30, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Dec 2023 --> Jun 2024 | Trial primary completion date: Dec 2023 --> Jun 2024
Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
paclitaxel • izalontamab (SI-B001)
9ms
SI-B001 Combined With Irinotecan in the Treatment of Recurrent Metastatic Esophageal Squamous Cell Carcinoma. (clinicaltrials.gov)
P2, N=40, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Dec 2023 --> Apr 2024 | Trial primary completion date: Dec 2023 --> Apr 2024
Trial completion date • Trial primary completion date • Metastases
|
irinotecan • izalontamab (SI-B001)
9ms
SI-B001 Combined With Chemotherapy in the Treatment of EGFR/ALK WT Recurrent or Metastatic NSCLC. (clinicaltrials.gov)
P2, N=60, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Dec 2023 --> Apr 2024 | Trial primary completion date: Dec 2023 --> Apr 2024
Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
|
EGFR wild-type • ALK wild-type • EGFR wild-type + ALK wild-type
|
cisplatin • paclitaxel • docetaxel • pemetrexed • izalontamab (SI-B001)
9ms
A Study of SI-B001, an EGFR/HER3 Bispecific Antibody, in Locally Advanced or Metastatic Epithelial Tumors (clinicaltrials.gov)
P1, N=60, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Dec 2023 --> Apr 2024 | Trial primary completion date: Dec 2023 --> Apr 2024
Trial completion date • Trial primary completion date • Metastases
|
izalontamab (SI-B001)
9ms
The phase I/II eNRGy trial: Zenocutuzumab in patients with cancers harboring NRG1 gene fusions. (PubMed, Future Oncol)
Zenocutuzumab is a novel, bispecific IgG1 antibody that targets both HER2 and HER3 proteins and inhibits NRG1 binding through a 'Dock & Block®' mechanism of action. Here, we describe the rationale and design of the phase II component of the eNRGy trial, part of the overall, open-label phase I/II, multicenter trial exploring the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and antitumor activity of zenocutuzumab in patients with NRG1+ NSCLC, PDAC or other solid tumors.
P1/2 data • Review • Journal
|
HER-2 (Human epidermal growth factor receptor 2) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3) • NRG1 (Neuregulin 1)
|
NRG1 fusion • NRG1 fusion
|
zenocutuzumab (MCLA-128)
10ms
ERBB3 overexpression is enriched in diverse patient populations with castration-sensitive prostate cancer and is associated with a unique AR activity signature. (PubMed, Clin Cancer Res)
In diverse CSPC patient populations, ERBB3 OE was associated with high AR signaling despite low intraprostatic androgen. Mechanistic studies demonstrated a direct link between HER3 and enzalutamide resistance. ERBB3 OE as a biomarker could thus stratify patients for intensification of therapy in castration-sensitive disease, including targeting HER3 directly to improve sensitivity to AR-targeted therapies.
Journal
|
ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3)
|
ERBB3 expression • ERBB3 overexpression • AR expression
|
Xtandi (enzalutamide capsule) • patritumab (U3-1287)
10ms
The Therapeutic Significance of HER3 in Non-small Cell Lung Cancer (NSCLC): A Review Study. (PubMed, Curr Med Chem)
Monoclonal antibodies such as lumretuzumab, seribantumab, and patritumab have shown potential in targeting HER3 to overcome resistance to epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs). Additionally, antibody-drug conjugates (ADCs) like HER3-DXd (patritumab deruxtecan) are new drug candidates that have demonstrated selective delivery of cytotoxic chemicals to NSCLC cells by exploiting HER3's widespread expression, minimizing cytotoxicity. This review aims to evaluate the efficacy of current HER3 therapeutics in development and their therapeutic potential in NSCLC, incorporating evidence from clinical trials.
Review • Journal
|
HER-2 (Human epidermal growth factor receptor 2) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3)
|
ERBB3 expression
|
patritumab deruxtecan (U3-1402) • seribantumab (MM-121) • lumretuzumab (RG7116)
10ms
A Study of Zenocutuzumab (MCLA-128) in Patients With Solid Tumors Harboring an NRG1 Fusion (eNRGy) (clinicaltrials.gov)
P2, N=250, Recruiting, Merus N.V. | Trial completion date: Dec 2024 --> Dec 2026 | Trial primary completion date: Dec 2022 --> Dec 2026
Trial completion date • Trial primary completion date
|
NRG1 (Neuregulin 1)
|
NRG1 fusion • NRG1 fusion
|
zenocutuzumab (MCLA-128)
10ms
SIBP-03, a novel anti-HER3 antibody, exerts antitumor effects and synergizes with EGFR- and HER2-targeted drugs. (PubMed, Acta Pharmacol Sin)
Importantly, SIBP-03 enhanced the antitumor activity of EGFR- or HER2-targeted drugs (cetuximab or trastuzumab) in vitro and in vivo. The mechanisms underlying this synergy involve increased inhibition of HER3-mediated downstream signaling. Collectively, these results demonstrated that SIBP-03, which is currently undergoing a Phase I clinical trial in China, may offer a new treatment option for patients with cancers harboring activated HER3, particularly as part of a combinational therapeutic strategy.
Journal
|
EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2)
|
Herceptin (trastuzumab) • Erbitux (cetuximab)
11ms
Clinical Trial of SIBP-03 in Patients With Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov)
P2, N=69, Not yet recruiting, Shanghai Institute Of Biological Products
New P2 trial • Metastases
|
Erbitux (cetuximab)
11ms
Trial completion date • Trial primary completion date
|
NRG1 (Neuregulin 1)
|
NRG1 fusion
|
Gilotrif (afatinib) • Xtandi (enzalutamide capsule) • abiraterone acetate • zenocutuzumab (MCLA-128)
11ms
A Phase Ⅰa Clinical Study Exploring Efficacy of SIBP-03 When Treating the Patients With Advanced Malignant Solid Tumors. (clinicaltrials.gov)
P1, N=36, Completed, Shanghai Institute Of Biological Products | Recruiting --> Completed | N=68 --> 36
Trial completion • Enrollment change • Metastases
|
EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3) • NOTCH1 (Notch 1) • NRG1 (Neuregulin 1) • NOTCH2 (Notch 2) • FAT1 (FAT atypical cadherin 1) • NOTCH4 (Notch 4)
|
HER-2 overexpression
|
docetaxel
12ms
A Study of SI-B001+SI-B003± Chemotherapy in the Treatment of Locally Advanced or Metastatic Non-small Cell Lung Cancer (clinicaltrials.gov)
P1/2, N=160, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting | Trial completion date: Aug 2025 --> Nov 2025 | Initiation date: Aug 2023 --> Oct 2023 | Trial primary completion date: Aug 2025 --> Nov 2025
Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • MET (MET proto-oncogene, receptor tyrosine kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK (Neurotrophic receptor tyrosine kinase)
|
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)
1year
Role of tumor microenvironment derived NRG1 in androgen resistance: Implications for a novel prostate cancer treatment strategy (SUO 2023)
Lysates were collected and prepared for western blot analysis to assess for activation of downstream signaling cascades, both with and without zenocutuzumab and enzalutamide treatment. Here, we show that NRG1 promotes prostate cancer cell survival and resistance to AR inhibition in PTEN wild-type prostate cancer cells. Activation of downstream PI3K-AKT signaling in a prostate cancer epithelial cell line was seen after both recombinant NRG1 stimulation and culturing with cancer associated fibroblast conditioned media. This supports a paracrine mediated action of NRG1 whereby it is secreted by stromal cells in the tumor microenvironment to promote resistance through PI3K signaling.
HER-2 (Human epidermal growth factor receptor 2) • PTEN (Phosphatase and tensin homolog) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3) • NRG1 (Neuregulin 1)
|
Xtandi (enzalutamide capsule) • zenocutuzumab (MCLA-128)
1year
A Study of SI-B001, an EGFR/HER3 Bispecific Antibody, in Locally Advanced or Metastatic Epithelial Tumors (clinicaltrials.gov)
P1, N=60, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Aug 2023 --> Dec 2023 | Trial primary completion date: Aug 2023 --> Dec 2023
Trial completion date • Trial primary completion date • Metastases
|
izalontamab (SI-B001)
1year
A Clinical Study to Evaluate the Efficacy and Safety of SI-B001 in the Treatment of Recurrent and Metastatic HNSCC (clinicaltrials.gov)
P2, N=30, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Jul 2023 --> Dec 2023 | Trial primary completion date: Jul 2023 --> Dec 2023
Trial completion date • Trial primary completion date • Metastases
|
izalontamab (SI-B001)
1year
SI-B001 Combined With Irinotecan in the Treatment of Recurrent Metastatic Esophageal Squamous Cell Carcinoma. (clinicaltrials.gov)
P2, N=40, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Sep 2023 --> Dec 2023 | Trial primary completion date: Sep 2023 --> Dec 2023
Trial completion date • Trial primary completion date • Metastases
|
irinotecan • izalontamab (SI-B001)
1year
A Clinical Study of SI-B001 in Combination With Paclitaxel in the Treatment of Recurrent and Metastatic HNSCC (clinicaltrials.gov)
P2, N=30, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Jul 2023 --> Dec 2023 | Trial primary completion date: Jul 2023 --> Dec 2023
Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
paclitaxel • izalontamab (SI-B001)
1year
Durable efficacy of zenocutuzumab, a HER2 x HER3 bispecific antibody, in advanced NRG1 fusion-positive (NRG1+) non-small cell lung cancer (NSCLC) (ESMO Asia 2023)
No pt discontinued Zeno for a treatment related AE. Conclusions In this updated analysis, Zeno provides robust and durable efficacy in advanced NRG1+ NSCLC, with a well-tolerated safety profile.
Clinical • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3) • NRG1 (Neuregulin 1) • CD74 (CD74 Molecule) • SLC3A2 (Solute Carrier Family 3 Member 2)
|
NRG1 fusion • NRG1 fusion
|
zenocutuzumab (MCLA-128)