Nimotuzumab

Summary

Nimotuzumab (CHEMBL2108359) is a phase-3 clinical-stage antibody; indicated across 33 conditions including squamous cell carcinoma and carcinoma of esophagus; with CIViC clinical evidence for 3 variant-indication associations (e.g. EGFR Expression in glioblastoma).

At a glance

• Status: Max clinical phase 3 (not approved)
• Modality: Antibody
• Indications: 33 conditions
• Clinical trials: 125
• Precision-oncology evidence (CIViC): 3 variant–indication associations

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL2108359
Name	Nimotuzumab
Type	Antibody
Max phase	3

Also known as: Nimotuzumab, OSAG 101, THERACIM-HR3, THERALOC, NIMOTUZUMAB

Targets

Targets

No target linkage available.

Bioactivity

No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).

Target pathways

No target-pathway data for this drug (no mapped target genes).

Indications & clinical

Indications

33 indications (0 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).

Indication	Trial phase	MONDO	EFO
squamous cell carcinoma	3	MONDO:0005096	EFO:0000707
carcinoma of esophagus	3	MONDO:0019086	EFO:0002916
nasopharyngeal neoplasm	3	MONDO:0005375	EFO:0004252
exocrine pancreatic carcinoma	3	MONDO:0005192	EFO:0002618
glioblastoma	3	MONDO:0018177	EFO:0000519
head and neck squamous cell carcinoma	3	MONDO:0010150	EFO:0000181
adenocarcinoma	3	MONDO:0004970	EFO:0000228
esophageal squamous cell carcinoma	3	MONDO:0005580	EFO:0005922
head and neck cancer	3	MONDO:0005627	EFO:0006859
carcinoma	3	MONDO:0004993	EFO:0000313
diffuse intrinsic pontine glioma	3	MONDO:0006033	EFO:1000026
malignant pancreatic neoplasm	3	MONDO:0009831	EFO:1000359
nasopharyngeal carcinoma	3	MONDO:0015459	MONDO:0015459
non-small cell lung carcinoma	2	MONDO:0005233	EFO:0003060
gastric neoplasm	2	MONDO:0021085	EFO:0003897
rectal cancer	2	MONDO:0006519	EFO:1000657
hypopharyngeal carcinoma	2	MONDO:0005216	EFO:0002938
oropharynx cancer	2	MONDO:0004608	EFO:1001931
brainstem cancer	2	MONDO:0002912	MONDO:0002914
breast neoplasm	2	MONDO:0021100	MONDO:0007254
lung neoplasm	2	MONDO:0021117	MONDO:0008903
oral cavity squamous cell carcinoma	2	MONDO:0004958	EFO:0000199
penile neoplasm	2	MONDO:0006895	MONDO:0001325
pancreatic neuroendocrine neoplasm	2	MONDO:0005815	EFO:0007331
hepatocellular carcinoma	2	MONDO:0007256	EFO:0000182
paraganglioma	2	MONDO:0000448	EFO:1000453
colorectal neoplasm	2	MONDO:0005335	MONDO:0005575
neoplasm	1	MONDO:0005070	EFO:0000616

5 further indication records had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.

Clinical trials

Total trials: 125.

Phase distribution

Phase	Trials
PHASE2	77
PHASE3	19
Not specified	9
PHASE2/PHASE3	6
PHASE1/PHASE2	6
PHASE1	6
PHASE4	2

Top trials by phase / activity

NCT	Phase	Status	Title
NCT06879691	PHASE4	ACTIVE_NOT_RECRUITING	A Trial of Nimotuzumab and Pinkiller Efficacy and Pain in Advanced Head and Neck Squamous Cell Carcinoma
NCT02293356	PHASE4	UNKNOWN	Phase IV Clinical Trial of Nimotuzumab in the Treatment of Nasopharyngeal Carcinoma
NCT04821778	PHASE3	RECRUITING	Chemoradiotherapy in Esophageal or Esophagogastric Junction Cancer
NCT04821843	PHASE3	RECRUITING	Neoadjuvant Treatment Modalities in Esophageal Cancer
NCT05772208	PHASE3	RECRUITING	Intensified Treatments for Patients With Locally Advanced Nasopharyngeal Carcinoma With Detectable EBV DNA After One Cycle GP Regime Neoadjuvant Chemotherapy
NCT06026878	PHASE3	RECRUITING	GNT Induction Treatment in Locally Advanced NPC
NCT06333821	PHASE3	NOT_YET_RECRUITING	A Study of Nimotuzumab Plus Concurrent Chemoradiotherapy Sequential Maintenance Treatment for Cervical Carcinoma
NCT06343116	PHASE3	NOT_YET_RECRUITING	Nimotuzumab Combined With Trifluridine/Tipiracil in the Treatment of Refractory Metastatic Colorectal Cancer
NCT06409429	PHASE2/PHASE3	NOT_YET_RECRUITING	Nimotuzumab Combined With GX as Postoperative Adjuvant Therapy in Pancreatic Cancer
NCT06561763	PHASE3	NOT_YET_RECRUITING	TPC VS. GP Induced Chemotherapy Combined With Nimotuzumab and Toripalimab in the Treatment of Locally Advanced Nasopharyngeal Carcinoma
NCT07333274	PHASE3	RECRUITING	Compare Radiotherapy Plus Nimotuzumab Versus Radiotherapy Alone in Platinum-ineligible Patients With Locoregionally Advanced Head and Neck Squamous Cell Carcinoma
NCT07445048	PHASE3	RECRUITING	Postoperative Radiotherapy Combined With Nimotuzumab Followed by Benmelstobart in High-Risk Patients With Head and Neck Squamous Cell Carcinoma
NCT07535567	PHASE2/PHASE3	NOT_YET_RECRUITING	Postoperative Radiotherapy With Nimotuzumab ± Benmelstobart in Intermediate-Risk Head and Neck Squamous Cell Carcinoma
NCT00561990	PHASE2/PHASE3	COMPLETED	Nimotuzumab in Adults With Pancreatic Cancer
NCT00753246	PHASE3	COMPLETED	Nimotuzumab in Adults With Glioblastoma Multiforma
NCT00957086	PHASE3	UNKNOWN	Study of Post-Op Adjuvant Concurrent Chemo-RT With or Without Nimotuzumab for Head & Neck Cancer
NCT01074021	PHASE3	UNKNOWN	Nimotuzumab in Combination With Chemoradiation for Nasopharyngeal Cancer
NCT01249352	PHASE2/PHASE3	COMPLETED	A Study of Chemoradiation Associated with Nimotuzumab As the Treatment of Locally Advanced Esophageal Cancer
NCT01345084	PHASE3	WITHDRAWN	Study Comparing Radiation Therapy and Chemotherapy With or Without Nimotuzumab
NCT01402180	PHASE2/PHASE3	UNKNOWN	Chemoradiation With or Without Nimotuzumab in Treating Esophageal Cancer Patients Who Suffer With Recurrence in Regional Lymph Nodes After Esophagectomy
NCT01813253	PHASE3	TERMINATED	Phase 3 Study of Nimotuzumab and Irinotecan as Second Line With Advanced or Recurrect Gastric and Gastroesophageal Junction Cancer
NCT02272699	PHASE2/PHASE3	WITHDRAWN	Neoadjuvant Treatment of Nimotuzumab With Chemotherapy or Radiotherapy in Resectable Esophageal Squamous Cell Carcinoma
NCT02395016	PHASE3	COMPLETED	A Study of Nimotuzumab Combinated With Gemcitabine in K-RAS Wild-type Locally Advanced and Metastatic Pancreatic Cancer
NCT02409186	PHASE3	UNKNOWN	A Phase III Study of Nimotuzumab Plus Concurrent Chemoradiotherapy in Loco-regional Esophageal Squamous Cell Carcinoma
NCT02611700	PHASE3	UNKNOWN	Nimotuzumab in Combined With Paclitaxel and Cisplatin for Treatment of Metastatic Esophageal Squamous Cell Carcinoma
NCT03837808	PHASE3	UNKNOWN	Radiotherapy Plus Concurrent Nimotuzumab or Cisplatin in Stage II-III Nasopharyngeal Carcinoma
NCT06781073	PHASE3	COMPLETED	Nimotuzumab in Combined With Chemotherapy for Treatment of IVB Stage,Rrecurrent or Persistent Cervical Carcinoma
NCT04223024	PHASE2	ACTIVE_NOT_RECRUITING	Concurrent Chemoradiotherapy With Nimotuzumab for High Risk Nasopharyngeal Carcinoma
NCT05316480	PHASE2	NOT_YET_RECRUITING	Nimotuzumab in EGFR Highly Expressed Pancreatic Neuroendocrine Neoplasms
NCT06389760	PHASE2	RECRUITING	Nimotuzumab Combined With mFOLFIRINOX/GX as Postoperative Adjuvant Therapy in Pancreatic Cancer
NCT06404840	PHASE2	RECRUITING	Evaluating Nimotuzumab in Combination With AG Regimen for Pancreatic Cancer With Liver Metastases : A Prospective, Single-Arm, Phase II Study
NCT06413017	PHASE2	RECRUITING	Nimotuzumab Combined With ICIs for the Treatment of Advanced Liver Cancer After First Line Treatment Failure
NCT06422156	PHASE2	NOT_YET_RECRUITING	SBRT Combined With Nimotuzumab and Mono-chemotherapy in Locally Advanced Pancreatic Cancer
NCT06429904	PHASE2	ACTIVE_NOT_RECRUITING	Nimotuzumab Plus NALIRIFOX in Locally Advanced Pancreatic Cancer
NCT06490341	PHASE2	NOT_YET_RECRUITING	GP Combined With Nimotuzumab and Sintilimab as Induction Therapy for Nasopharyngeal Carcinoma
NCT06509009	PHASE2	RECRUITING	Nimotuzumab Combined With TGP as First-line Therapy in Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma
NCT06718205	PHASE2	RECRUITING	Nimotuzumab Combined With Sintilimab and Chemotherapy for Advanced Esophageal Squamous Cell Carcinoma
NCT06722911	PHASE2	RECRUITING	Study of Adjuvant Nimotuzumab Combined with Nab-paclitaxel+ Gemcitabine in EGFR-positive Pancreatic Cancer
NCT06770452	PHASE2	RECRUITING	HRS-4642 With Nimotuzumab and Chemotherapy for First-line Treatment of Advanced Pancreatic Cancer Patients
NCT06771596	PHASE2	ACTIVE_NOT_RECRUITING	Nimotuzumab High-risk, Locally Advanced Squamous Cell Carcinoma of the Cervix

Clinical evidence (CIViC)

Variant × indication × effect (3 predictive associations from 3 curated evidence items):

Variant	Indication	Effect	Therapy	Level	CIViC
EGFR Expression	Glioblastoma	Sensitivity/Response	Temozolomide + Nimotuzumab + 3-Dimensional Conformal Radiation Therapy	CIViC B	EID8299
EGFR Overexpression	Esophagus Squamous Cell Carcinoma	Sensitivity/Response	Nimotuzumab	CIViC B	EID783
EGFR VIII	Brain Glioma	Sensitivity/Response	Nimotuzumab	CIViC D	EID1017

Pharmacology

Pharmacogenomics

No PharmGKB pharmacogenomic data curated for this drug.

Related molecules

Related molecules

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).