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DRUG:

TheraCIM (nimotuzumab)

i
Company:
Biocon, Daiichi Sankyo, Oncoscience
Drug class:
EGFR inhibitor
Related drugs:
2d
AG Plus Nimotuzumab Sequential Irreversible Electroporation Ablation for Locally Advanced Pancreatic Cancer (clinicaltrials.gov)
P2, N=48, Not yet recruiting, Tianjin Medical University Cancer Institute and Hospital
New P2 trial
|
gemcitabine • albumin-bound paclitaxel • TheraCIM (nimotuzumab)
12d
Neoadjuvant toripalimab plus nimotuzumab combined with taxol-based chemotherapy in locally advanced penile squamous cell carcinoma. (PubMed, Cancer Cell)
Biomarker analysis identified PD-L1 expression, TP53 mutation status, and CD8+ T cell density as potential predictive markers. Therefore, neoadjuvant TNT shows promising anti-tumor activity and acceptable toxicity.
Journal • PD(L)-1 Biomarker • IO biomarker
|
PD-L1 (Programmed death ligand 1) • TP53 (Tumor protein P53) • CD8 (cluster of differentiation 8)
|
PD-L1 expression • TP53 mutation
|
paclitaxel • Loqtorzi (toripalimab-tpzi) • TheraCIM (nimotuzumab)
15d
Trial completion date • Trial primary completion date
|
EGFR (Epidermal growth factor receptor)
|
docetaxel • TheraCIM (nimotuzumab)
16d
New P2 trial
|
Loqtorzi (toripalimab-tpzi) • TheraCIM (nimotuzumab)
22d
New P2 trial
|
EGFR (Epidermal growth factor receptor)
|
cisplatin • paclitaxel • Tevimbra (tislelizumab-jsgr) • TheraCIM (nimotuzumab)
22d
New P1/2 trial
|
KRAS (KRAS proto-oncogene GTPase) • CA 19-9 (Cancer antigen 19-9)
|
KRAS mutation • KRAS G12D • KRAS G12
|
TheraCIM (nimotuzumab) • HRS-4642
22d
Clinical study of nimotuzumab combination regimen in locally advanced hypopharyngeal/laryngeal cancer (ChiCTR2500096991)
P=N/A, N=27, Recruiting, Bejing Tongren Hospital, Capital Medical Uniersity; Bejing Tongren Hospital, Capital Medical Uniersity
New trial
|
EGFR (Epidermal growth factor receptor)
|
EGFR expression
|
TheraCIM (nimotuzumab)
29d
Enrollment open
|
TheraCIM (nimotuzumab) • HRS-4642
1m
An Anti-EGFR Antibody-Drug Radioconjugate Labeled with Actinium-225 Elicits Durable Anti-Tumor Responses in KRAS and BRAF Mutant Colorectal Cancer. (PubMed, Cancer Res)
PET imaging using the non-overlapping anti-EGFR radioimmunoconjugate [89Zr]Zr-DFO-matuzumab before and after treatment of orthotopic CRC xenografts showed that 1/5 mice from the treatment group had complete remission while metastatic spread was prevented in the other mice (4/5). These results show that treatment with [225Ac]Ac-macropa-nimotuzumab-PEG6-DM1 is a potential therapeutic approach for KRAS mutant and BRAFV600E mutant metastatic CRC.
Journal
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KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene)
|
BRAF V600E • KRAS mutation • BRAF mutation • BRAF V600 • EGFR positive
|
TheraCIM (nimotuzumab) • matuzumab (EMD 72000)
1m
Colorectal Cancer: Risk Factors, Novel Approaches in Molecular Screening and Treatment. (PubMed, Int J Mol Cell Med)
Medications like Nimotuzumab, Cetuximab, and Panitumumab target the Epidermal Growth Factor Receptor (EGFR), which EGF activates. HER2, activated by ligands, is the focus of drugs like Trastuzumab and Pertuzumab. The PD-1/PD-L1 and CTLA-4 pathways, as the immune checkpoints, which involve T cells, are targeted by medications like Ipilimumab...HIF1A-AS1, CRNDE-h, NEAT1, ZFAS1, and GAS5, along with IGFBP-2, have demonstrated significant CRC diagnostic capacity. Compared to CRC patients with low HIF1A-AS1 expression, individuals with high expression levels were linked to a worse 5-year survival rate.
Review • Journal • PD(L)-1 Biomarker • IO biomarker
|
EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • HIF1A (Hypoxia inducible factor 1, alpha subunit) • NEAT1 (Nuclear Paraspeckle Assembly Transcript 1) • IGFBP2 (Insulin-like growth factor binding protein 2) • GAS5 (Growth Arrest Specific 5) • ZFAS1 (ZNFX1 Antisense RNA 1) • CRNDE (Colorectal Neoplasia Differentially Expressed)
|
Herceptin (trastuzumab) • Erbitux (cetuximab) • Yervoy (ipilimumab) • Vectibix (panitumumab) • Perjeta (pertuzumab) • TheraCIM (nimotuzumab)
1m
New P4 trial
|
cisplatin • TheraCIM (nimotuzumab)
2ms
Concurrent Chemoradiotherapy with Nimotuzumab for High Risk Nasopharyngeal Carcinoma (clinicaltrials.gov)
P2, N=246, Active, not recruiting, Sun Yat-sen University | Trial primary completion date: Dec 2022 --> Aug 2024
Trial primary completion date
|
cisplatin • TheraCIM (nimotuzumab)
2ms
Cost-effectiveness analysis of nimotuzumab combined with gemcitabine for K-Ras wild type locally advanced or metastatic pancreatic cancer in China. (PubMed, Sci Rep)
The ICER consistently well exceeded the willingness-to-pay (WTP) threshold and negative INHBs were observed across all patient subcategories with zero alteration recorded as cost-effective in the subgroup analyses. Nimotuzumab plus gemcitabine, relative to gemcitabine alone, is not a cost-effective first-line treatment among patients with K-Ras wild type LA or mPC at the current prices offered in China.
Journal • HEOR • Cost-effectiveness
|
KRAS (KRAS proto-oncogene GTPase) • RAS (Rat Sarcoma Virus)
|
RAS wild-type
|
gemcitabine • TheraCIM (nimotuzumab)
2ms
New trial
|
gemcitabine • TheraCIM (nimotuzumab)
2ms
Predicting progression-free survival using dynamic contrast-enhanced imaging-based radiomics in advanced nasopharyngeal carcinoma patients treated with nimotuzumab. (PubMed, Eur Radiol)
Question How can the response to nimotuzumab treatment in patients with locally advanced nasopharyngeal carcinoma be accurately predicted using non-invasive imaging methods? Findings A combined clinical and radiomic model using dynamic contrast-enhanced magnetic resonance imaging showed improved predictive performance for progression-free survival in patients treated with nimotuzumab. Clinical relevance The study provides evidence for using a combined clinical and radiomic approach, offering a non-invasive method to predict treatment response and guide personalized treatment strategies for patients with locally advanced nasopharyngeal carcinoma, potentially improving patient outcomes.
Journal
|
EGFR (Epidermal growth factor receptor)
|
EGFR expression
|
TheraCIM (nimotuzumab)
2ms
Latest Advancements in the Management of H3K27M-Mutant Diffuse Intrinsic Pontine Glioma: A Narrative Review. (PubMed, Cancers (Basel))
These include nimotuzumab (an anti-EGFR drug) and vinorelbine (a semisynthetic vinca alkaloid) in combination, Panobinostat (a histone deacetylase inhibitor), ONC201 (a drug that blocks the dopamine receptor D2 and inactivates Akt and ERK kinases), and chimeric antigen receptor (CAR) T cells. Because the H3K27M mutation is linked to higher malignancy, a slightly higher dose could be used for the second round of local irradiation. Additionally, irradiating the entire craniospinal axis could help control both local and leptomeningeal disease.
Review • Journal
|
DRD2 (Dopamine Receptor D2)
|
vinorelbine tartrate • Farydak (panobinostat) • TheraCIM (nimotuzumab) • dordaviprone (ONC201)
2ms
Phase IIa Study of Nimotuzumab to Treat Colorectal Cancer (clinicaltrials.gov)
P1/2, N=31, Completed, Biotech Pharmaceutical Co., Ltd. | Phase classification: P2a --> P1/2
Phase classification
|
KRAS (KRAS proto-oncogene GTPase) • RAS (Rat Sarcoma Virus)
|
irinotecan • TheraCIM (nimotuzumab)
3ms
New trial
|
TheraCIM (nimotuzumab)
3ms
New P2 trial
|
PD-L1 (Programmed death ligand 1)
|
cisplatin • Loqtorzi (toripalimab-tpzi) • albumin-bound paclitaxel • Aqupla (nedaplatin) • TheraCIM (nimotuzumab)
3ms
New P2 trial
|
gemcitabine • albumin-bound paclitaxel • TheraCIM (nimotuzumab)
3ms
New P1/2 trial
|
TheraCIM (nimotuzumab) • HRS-4642
3ms
New P2 trial
|
KRAS (KRAS proto-oncogene GTPase)
|
gemcitabine • albumin-bound paclitaxel • TheraCIM (nimotuzumab) • HRS-4642
3ms
CC11: Nimotuzumab High-risk, Locally Advanced Squamous Cell Carcinoma of the Cervix (clinicaltrials.gov)
P2, N=43, Active, not recruiting, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
New P2 trial
|
TheraCIM (nimotuzumab)
3ms
Neurobiology of COVID-19-Associated Psychosis/Schizophrenia: Implication of Epidermal Growth Factor Receptor Signaling. (PubMed, Neuropsychopharmacol Rep)
In agreement, the anticancer drugs targeting EGFR such as Nimotuzumab and tyrosine kinase inhibitors are markedly effective on COVID-19...These animal models also display postpubertal abnormality in soliloquy-like self-vocalization as well as in intercortical functional connectivity. Here, we discuss neuropsychiatric implication of coronavirus infection and its interaction with the EGFR system, by searching related literatures in PubMed database as of the end of 2023.
Review • Journal
|
EGFR (Epidermal growth factor receptor)
|
TheraCIM (nimotuzumab)
3ms
The inhibitory effects of nimotuzumab on CD276 expression and immune escape in head and neck squamous cell carcinoma: Insights into anticancer mechanisms. (PubMed, Int Immunopharmacol)
However, no significant changes were observed in the populations of NK cells, DC cells, and neutrophils. These findings offer new insights into the anticancer mechanisms of nimotuzumab and its underlying synergy in combined treatments with immunotherapy for HNSCC.
Journal • IO biomarker
|
CD276 (CD276 Molecule) • TGFB1 (Transforming Growth Factor Beta 1)
|
CD276 expression
|
TheraCIM (nimotuzumab)
4ms
Neoadjuvant CRT Combined With Camrelizumab and Nimotuzumab for Initially Inoperable Patients With Esophageal Carcinoma (clinicaltrials.gov)
P2, N=35, Completed, Anhui Provincial Hospital | Recruiting --> Completed | Phase classification: P1/2 --> P2 | N=57 --> 35 | Trial completion date: Dec 2025 --> Mar 2024
Trial completion • Phase classification • Enrollment change • Trial completion date
|
AiRuiKa (camrelizumab) • TheraCIM (nimotuzumab)
4ms
Neoadjuvant CRT Combined With Camrelizumab and Nimotuzumab for Initially Inoperable Patients With Esophageal Carcinoma (clinicaltrials.gov)
P2, N=35, Completed, Anhui Provincial Hospital | Phase classification: P1/2 --> P2 | N=57 --> 35 | Trial completion date: Dec 2025 --> Mar 2024 | Recruiting --> Completed
Trial completion • Phase classification • Enrollment change • Trial completion date
|
AiRuiKa (camrelizumab) • TheraCIM (nimotuzumab)
4ms
The surgical safety margin after neoadjuvant chemotherapy combined with nimotuzumab leading to tumor regression. (PubMed, J Chin Med Assoc)
In summary, although there is no significant statistical difference between neoadjuvant chemotherapy with nimotuzumab combined with APF and APF alone in the pathological remission rate of locally advanced oral squamous cell carcinoma, there is a trend indicating that nimotuzumab combined with APF is superior.
Journal
|
EGFR (Epidermal growth factor receptor) • TP53 (Tumor protein P53)
|
EGFR expression • TP53 expression
|
cisplatin • 5-fluorouracil • albumin-bound paclitaxel • TheraCIM (nimotuzumab)
4ms
Enrollment change • Trial withdrawal • Surgery
|
carboplatin • gemcitabine • TheraCIM (nimotuzumab)
5ms
New P2 trial
|
gemcitabine • albumin-bound paclitaxel • TheraCIM (nimotuzumab)
5ms
New P2 trial • Metastases
|
cisplatin • paclitaxel • Tyvyt (sintilimab) • TheraCIM (nimotuzumab)
5ms
Nimotuzumab and irinotecan synergistically induce ROS-mediated apoptosis by endoplasmic reticulum stress and mitochondrial-mediated pathway in cervical cancer. (PubMed, Biotechnol Appl Biochem)
According to these observations, NmAb enhances the effectiveness of CPT-11 in fighting cancer by stimulating cell death in the HeLa cells. Therefore, NmAb has the potential to improve the efficacy of CPT-11 as a future cervical cancer treatment in humans.
Journal
|
EGFR (Epidermal growth factor receptor) • CASP3 (Caspase 3) • CASP8 (Caspase 8) • ANXA5 (Annexin A5)
|
irinotecan • TheraCIM (nimotuzumab)
6ms
New P2 trial • Metastases
|
Tevimbra (tislelizumab-jsgr) • TheraCIM (nimotuzumab)
7ms
Successful treatment of GEMOX regimen combined with nimotuzumab in the pancreatic cancer with wild KRAS and mutant BRCA: a report of two cases. (PubMed, AME Case Rep)
We used the combined chemotherapy of gemcitabine (1,000 mg/m2) + oxaliplatin (135 mg/m2) + nimotuzumab (400 mg). Then, the patients were treated with oral olaparide (600 mg/day) for one year, and survived without tumor progress for more than 1.5 years. These two cases achieved excellent effects of precise chemotherapy, which provided an important reference for the treatment of pancreatic cancer patients with wild KRAS and mutant BRCA.
Journal • BRCA Biomarker
|
EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • BRCA (Breast cancer early onset)
|
KRAS mutation • KRAS wild-type • RAS wild-type • EGFR negative • BRCA mutation
|
gemcitabine • oxaliplatin • TheraCIM (nimotuzumab)
7ms
A Real-World Comparison of Surgery Followed by Radiotherapy and Radical Radiotherapy for Cervical Cancer Based on Multicentre Retrospective Cohort in China (ChiCTR2400088002)
P=N/A, N=980, Completed, Xiangya Hospital of Central South University; Xiangya Hospital of Central South University
New trial • Real-world evidence • Surgery • Real-world
|
TheraCIM (nimotuzumab)
8ms
GASTO 1010: Neoadjuvant Nimotuzumab Plus Gemcitabine and Carboplatin in Unresectable Stage III Squamous Cell Lung Carcinoma (clinicaltrials.gov)
P2, N=37, Recruiting, Sun Yat-sen University | Unknown status --> Recruiting | Trial completion date: Oct 2020 --> Oct 2027 | Trial primary completion date: Oct 2018 --> Oct 2025
Enrollment open • Trial completion date • Trial primary completion date • Surgery
|
carboplatin • gemcitabine • TheraCIM (nimotuzumab)
8ms
Enrollment open • Metastases
|
EGFR (Epidermal growth factor receptor)
|
paclitaxel • TheraCIM (nimotuzumab)
8ms
Multispectral fluorescence imaging of EGFR and PD-L1 for precision detection of oral squamous cell carcinoma: a preclinical and clinical study. (PubMed, BMC Med)
EGFR and PD-L1 are highly expressed in OSCC, the combination of which is important for a precise prognosis of OSCC. EGFR and PD-L1 expression can be sensitively detected using the newly synthesized multispectral fluorescence imaging probes Nimotuzumab-ICG and Atezolizumab-Cy5.5, which can facilitate the sensitive and specific detection of OSCC and improve treatment outcomes.
Preclinical • Journal • PD(L)-1 Biomarker • IO biomarker
|
EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1)
|
Tecentriq (atezolizumab) • TheraCIM (nimotuzumab)
8ms
New P3 trial • Head-to-Head • Metastases
|
Opdivo (nivolumab) • cisplatin • gemcitabine • Loqtorzi (toripalimab-tpzi) • capecitabine • albumin-bound paclitaxel • TheraCIM (nimotuzumab)
9ms
Nimotuzumab Combined With TGP as First-line Therapy in Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma (clinicaltrials.gov)
P2, N=30, Not yet recruiting, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
New P2 trial • Metastases
|
cisplatin • gemcitabine • Loqtorzi (toripalimab-tpzi) • TheraCIM (nimotuzumab)
9ms
New P2 trial
|
PD-L1 (Programmed death ligand 1)
|
Opdivo (nivolumab) • Tevimbra (tislelizumab-jsgr) • TheraCIM (nimotuzumab)
9ms
A prospective, single arm study of Nimotuzumab combined with NALIRIFOX in the treatment of locally advanced pancreatic cancer (ChiCTR2400084660)
P2, N=31, Not yet recruiting, Peking Union Medical College Hospital; Peking Union Medical College Hospital
New P2 trial
|
EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase)
|
5-fluorouracil • oxaliplatin • leucovorin calcium • TheraCIM (nimotuzumab) • Onivyde (nanoliposomal irinotecan)