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DRUG:

TheraCIM (nimotuzumab)

i
Other names: DE-766, h-R3, OSAG101, anti-EGFR mAb hR3, DE 766, DE766, OSAG-101, OSAG 101
Company:
Biocon, Biotech Pharma, Daiichi Sankyo
Drug class:
EGFR inhibitor
Related drugs:
3d
Reversal of KRAS G12D inhibitor resistance by nimotuzumab via MEK/ERK-mediated unfolded protein response in pancreatic cancer. (PubMed, Cancer Lett)
Our findings not only reveal a clinically relevant resistance mechanism to KRAS G12D inhibition but also provide a rational, effective combined strategy. Ultimately, the combination of HRS-4642 with nimotuzumab offers a promising therapeutic strategy for PDAC patients harboring KRAS G12D mutations, laying a foundation for advancing clinical research in overcoming resistance to KRAS G12D-targeted therapies.
Journal
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KRAS (KRAS proto-oncogene GTPase)
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KRAS mutation • KRAS G12D
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TheraCIM (nimotuzumab) • HRS-4642
3d
Nimotuzumab combined with gemcitabine and nab-paclitaxel as first-line therapy for advanced pancreatic cancer: a single-arm, single-center Phase II prospective study. (PubMed, Front Med (Lausanne))
The NTZ-AG regimen demonstrated meaningful anti-tumor activity and an acceptable safety profile as first-line therapy for unselected advanced pancreatic cancer patients, providing a rational basis for larger randomized controlled trials. This trial was registered at the Chinese Clinical Trial Register (ChiCTR) under the registration number ChiCTR2300072843 having URL https://www.chictr.org.cn/showprojEN.html?proj=198791.
Clinical • P2 data • Journal
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KRAS (KRAS proto-oncogene GTPase)
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KRAS wild-type • RAS wild-type
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gemcitabine • albumin-bound paclitaxel • TheraCIM (nimotuzumab)
15d
Enrollment change
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KRAS (KRAS proto-oncogene GTPase)
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gemcitabine • albumin-bound paclitaxel • TheraCIM (nimotuzumab) • HRS-4642
22d
HRS-4642 Combined With Nimotuzumab in the Treatment of Recurrent or Metastatic Pancreatic Ductal Adenocarcinoma (clinicaltrials.gov)
P1/2, N=20, Active, not recruiting, West China Hospital | Trial primary completion date: Jan 2027 --> Aug 2026 | Recruiting --> Active, not recruiting
Enrollment closed • Trial primary completion date
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TheraCIM (nimotuzumab) • HRS-4642
23d
Pancreatic Ductal Adenocarcinoma with ITSN1-ALK Fusion: Sustained Response to Alectinib with 19-Month Progression-Free Survival. (PubMed, Oncologist)
Oncologists should consider broad next-generation sequencing, including fusion detection, for patients with KRAS-wildtype PDAC. When an ALK fusion is identified, ALK inhibitor therapy can yield durable disease control.
Journal
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KRAS (KRAS proto-oncogene GTPase) • TP53 (Tumor protein P53) • CA 19-9 (Cancer antigen 19-9)
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TP53 mutation • ALK positive • KRAS wild-type • ALK fusion • RAS wild-type
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gemcitabine • Alecensa (alectinib) • Lorbrena (lorlatinib) • capecitabine • albumin-bound paclitaxel • TheraCIM (nimotuzumab)
27d
New P2 trial
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PD-L1 (Programmed death ligand 1)
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Keytruda (pembrolizumab) • cisplatin • carboplatin • docetaxel • Tevimbra (tislelizumab-jsgr) • albumin-bound paclitaxel • TheraCIM (nimotuzumab)
1m
Efficacy and safety of targeted therapies for glioblastoma: a systematic review and network meta-analysis. (PubMed, BMC Cancer)
Bevacizumab was associated with improved PFS, but not OS compared to standard therapy and other targeted therapies in newly diagnosed GBM patients. Exploratory subgroup findings suggested that nivolumab may be associated with less favorable OS and PFS estimates in MGMT-unmethylated patients. SUCRA rankings should be interpreted as exploratory because most interventions were supported by limited trial evidence. However, certain targeted drugs exhibit inadequate safety profiles, and careful risk-benefit assessment is required. Future research should further explore safer and more effective multi-targeted combination strategies to overcome GBM's survival bottleneck.
Retrospective data • Journal
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MGMT (6-O-methylguanine-DNA methyltransferase)
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Opdivo (nivolumab) • Avastin (bevacizumab) • temozolomide • Recentin (cediranib) • TheraCIM (nimotuzumab) • depatuxizumab mafodotin (ABT-414) • marizomib (NPI-0052)
1m
Nimotuzumab Combined With Concurrent Curative Radiotherapy and S-1 in 75 Years and Older Patients With Stage II-IVB Esophageal Squamous Cell Carcinoma: A Phase II Study. (PubMed, Int J Cancer)
Among survivors, 45.5% reported high satisfaction with their QOL, and 84.8% did not experience weight loss. This combination therapy demonstrated promising efficacy and safety, suggesting it may be a viable treatment option for this patient population.
P2 data • Journal
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EGFR (Epidermal growth factor receptor)
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TheraCIM (nimotuzumab)
2ms
A multicenter, single-arm phase II clinical study of eribulin combined with inituzumab and pyrotinib in the treatment of HER2-positive advanced breast cancer (ChiCTR2600121825)
P2, N=76, Recruiting, Fifth Affiliated Hospital, Sun Yat-Sen University; Fifth Affiliated Hospital, Sun Yat-Sen University
New P2 trial
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 expression
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Irene (pyrotinib) • eribulin mesylate • TheraCIM (nimotuzumab)
2ms
A Prospective, Single-Arm, Phase II Study of Nimotuzumab Combined with Sintilimab and Neoadjuvant Chemotherapy in the Treatment of Locally Advanced Resectable Esophageal Squamous Cell Carcinoma (ChiCTR2600120859)
P2, N=36, Recruiting, Langfang Campus of Chinese Academy of Medical Sciences Cancer Hospital; Langfang Campus of Chinese Academy of Medical Sciences Cancer Hospital
New P2 trial
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Tyvyt (sintilimab) • TheraCIM (nimotuzumab)
2ms
New trial
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AiRuiKa (camrelizumab) • TheraCIM (nimotuzumab) • Tomudex (raltitrexed)
2ms
New P2 trial
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cisplatin • gemcitabine • Teysuno (gimeracil/oteracil/tegafur) • TheraCIM (nimotuzumab)