TheraCIM (nimotuzumab) / Daiichi Sankyo, Biocon, Biotech Pharma - LARVOL DELTA

A novel 2+2 IgG-like bispecific antibody-drug conjugate targeting EBV GP220/350 and EGFR for selective treatment of nasopharyngeal carcinoma (AACR 2026) - "Epidermal growth factor receptor (EGFR) is also overexpressed in >80% of NPC cases and is a validated therapeutic target (e.g., cetuximab). Binding affinity, in vitro cytotoxicity and in vivo efficacy were assessed. DXA038-CPT113 showed superior activity both in vitro and in vivo compared to nimotuzumab-CPT113.This bispecific ADC represents a promising therapeutic strategy for EBV-positive NPC, addressing unmet needs in precision oncology."

ADC • Bispecific • Nasopharyngeal Carcinoma • Oncology • Solid Tumor • EGFR

CXCR4/LITAF as predictive biomarkers for nimotuzumab plus AG therapy in pancreatic cancer with liver metastasis: Integrative single-cell and spatial analysis (AACR 2026) - P2 | "While Gemcitabine plus Nab-paclitaxel (AG) remains the NCCN-recommended regimen for fit patients, outcomes remain suboptimal. Nimotuzumab plus AG demonstrates favorable disease control and conversion potential in PCLM. Integrative single-cell and spatial analyses identify CXCR4 and LITAF as candidate biomarkers linked to treatment response. The CXCR4/LITAF combined spatial score offers a quantitative imaging tool for predicting response to Nimotuzumab + AG in metastatic pancreatic cancer."

Biomarker • Hepatocellular Cancer • Oncology • Pancreatic Cancer • Solid Tumor • CXCR4 • KRAS

Phase III trial of adjuvant nimotuzumab plus cisplatin-based chemoradiotherapy in resected stage III/IV head and neck squamous cell carcinoma (ESMO 2025) - P3 | "Weekly cisplatin had lower toxicity than 3-weekly regimens without compromising efficacy. Investigator-initiated multi-centre trials such as this demonstrate the potential of assembling institutions beyond existing cooperative groups, using well-established independent QA systems in place."

Clinical • P3 data • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • EGFR

Impact of p16 Status on the Efficacy of Pembrolizumab Combined Nimotuzumab in Recurrent/Unresectable/Metastatic Head and Neck Squamous Cell Carcinoma Patients. (PubMed, Oral Dis) - "The combination of Pembrolizumab and Nimotuzumab demonstrates a notable enhancement in ORR and OS, maintaining a dependable safety profile. Differential p16 expression in HNSCC patients may influence the efficacy of immune-combined targeted therapy, highlighting the importance of considering p16 in the formulation of therapeutic strategies."

Journal • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Sequential nimotuzumab plus gemcitabine and nab-paclitaxel chemotherapy followed by irreversible electroporation in advanced pancreatic ductal adenocarcinoma: a retrospective real-world analysis. (PubMed, Cancer Biol Med) - No abstract available

Journal • Real-world evidence • Retrospective data • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma

Neoadjuvant chemoradiation with camrelizumab and nimotuzumab for initially inoperable esophageal squamous cell carcinoma: A single-arm phase 2 trial. (PubMed, Eur J Cancer) - P2 | "NCRCN regimen was a promising treatment strategy with a high surgical conversion rate in initially inoperable patients with LAESCC. TRIAL REGISTRATION CLINICALTRIALS."

Journal • P2 data • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastrointestinal Disorder • Hematological Disorders • Neutropenia • Oncology • Squamous Cell Carcinoma • CD8 • FOXP3

Efficacy and Safety of Neo-CRT Plus Serplulimab, Nimotuzumab in Patients With Locally Advanced Resectable ESCC (clinicaltrials.gov) - P2 | N=46 | Recruiting | Sponsor: Tianjin Medical University Cancer Institute and Hospital

New P2 trial • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma

Efficacy of Tunlametinib in Combination With Anti-EGFR Monoclonal Antibody in Patients With RAS-Mutated Advanced Gastrointestinal Malignancies (clinicaltrials.gov) - P2 | N=90 | Not yet recruiting | Sponsor: Chinese PLA General Hospital

New P2 trial • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

Postoperative Radiotherapy Combined With Nimotuzumab Followed by Bemcentinib in High-Risk Patients With Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - P3 | N=370 | Not yet recruiting | Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

New P3 trial • Head and Neck Cancer • Oncology • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Thyroid Gland Carcinoma • EGFR • PD-L1

Efficacy, safety, and survival outcomes of radiotherapy combined with nimotuzumab following induction chemotherapy in locally advanced head and neck cancer. (PubMed, Front Oncol) - "Given that nasopharyngeal carcinoma constituted the majority of the cohort, this combination regimen represents a particularly promising therapeutic strategy for nasopharyngeal carcinoma. However, because only a small number of non-nasopharyngeal head and neck cancers were included, the observed overall survival benefit should not be generalized to non-nasopharyngeal head and neck cancers, and further prospective studies in more homogeneous populations are warranted to validate these findings."

Journal • Head and Neck Cancer • Nasopharyngeal Carcinoma • Non Nasopharyngeal Head and Neck Cancer • Oncology • Solid Tumor

Efficacy, safety, and survival outcomes of radiotherapy combined with nimotuzumab following induction chemotherapy in locally advanced head and neck cancer (Front Oncol) - "In terms of long-term outcomes, the median overall survival was significantly longer in the observation group (42.3 months vs. 31.7 months, P = 0.008). Multivariate Cox regression analysis further confirmed nimotuzumab use as an independent protective factor for survival (HR = 0.62, 95% CI: 0.41–0.93, P = 0.021), while advanced T stage (T3–T4) and clinical stage (III–IV) were identified as independent risk factors."

Retrospective data • Head and Neck Cancer

Nimotuzumab Combined With Toripalimab and Chemotherapy for Locally Advanced Tonsillar Cancer (clinicaltrials.gov) - P2 | N=10 | Recruiting | Sponsor: Tang-Du Hospital

New P2 trial • Head and Neck Cancer • Oncology • Solid Tumor

Neoadjuvant toripalimab plus nimotuzumab combined with taxol-based chemotherapy in locally advanced penile squamous cell carcinoma. (PubMed, Cancer Cell) - P2 | "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."

IO biomarker • Journal • Oncology • Penile Cancer • Squamous Cell Carcinoma • CD8 • PD-L1 • TP53

HRS-4642 in Combination With Nimotuzumab and Chemotherapy for BRPC With KRAS G12D Mutation (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: Zhejiang University | Not yet recruiting ➔ Recruiting | Initiation date: Nov 2025 ➔ Feb 2026

Enrollment open • Trial initiation date • Oncology • Pancreatic Cancer • Solid Tumor • KRAS

PIONEER-HN: A Single-Arm Phase II Clinical Study of Docetaxel Combined With Nimotuzumab and Pucotenlimab as Second-Line and Beyond Therapy for Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: Sun Yat-sen University

New P2 trial • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

HRS-4642 combined with Nimotuzumab in the treatment of recurrent or metastatic pancreatic ductal adenocarcinoma with KRAS G12D mutation that has failed systemic therapy (ChiCTR) - P1/2 | N=20 | Recruiting | Sponsor: West China Hospital,Sichuan University; West China Hospital,Sichuan University | N=10 ➔ 20

Enrollment change • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • CA 19-9 • KRAS

Adebrelimab Neoadjuvant Treatment for Resectable ESCC (clinicaltrials.gov) - P=N/A | N=22 | Not yet recruiting | Sponsor: Tianjin Medical University Cancer Institute and Hospital

New trial • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma

A Prospective, Single-Arm, Phase II Clinical Study of Nimotuzumab Combined with Tislelizumab as Neoadjuvant Therapy for Patients with Locally Advanced Head and Neck Squamous Cell Carcinoma Who Are Intolerant to Platinum-Based Chemotherapy (ChiCTR) - P4 | N=48 | Not yet recruiting | Sponsor: Beijing Cancer Hospital; Beijing Cancer Hospital

New P4 trial • Head and Neck Cancer • Hypopharyngeal Cancer • Oncology • Oral Cancer • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • EGFR • PD-L1

Nimotuzumab Combined With Chemoradiotherapy in the Treatment of Unresectable Locally Advanced or Oligometastatic Pancreatic Cancer (clinicaltrials.gov) - P2 | N=30 | Enrolling by invitation | Sponsor: Peking University First Hospital

New P2 trial • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

A prospective, single arm, phase II clinical study of nimotuzumab combined with concurrent radiotherapy in the treatment of moderate risk patients after head and neck squamous cell carcinoma surgery (ChiCTR) - P2 | N=63 | Not yet recruiting | Sponsor: Tianjin Cancer Hospital; Tianjin Cancer Hospital

New P2 trial • Head and Neck Cancer • Oncology • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • EGFR

Neoadjuvant Treatment Modalities in Esophageal Cancer (clinicaltrials.gov) - P3 | N=2000 | Recruiting | Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Trial completion date: Dec 2025 ➔ Dec 2030 | Trial primary completion date: Dec 2025 ➔ Dec 2030

Trial completion date • Trial primary completion date • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Oncology

Radiotherapy combined with nimotuzumab versus radiotherapy alone in patients with platinum-intolerant locally advanced head and neck squamous cell carcinoma (ChiCTR) - P3 | N=335 | Not yet recruiting | Sponsor: Shandong First Medical University Affiliated Cancer Hospital; Shandong First Medical University Affiliated Cancer Hospital

New P3 trial • Head and Neck Cancer • Oncology • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • EGFR

Nimotuzumab plus concurrent chemoradiotherapy for locally advanced cervical squamous cell carcinoma: The randomized, phase 3 CC3 study. (ASCO 2024) - P=N/A | " All patients with locally advanced cervical squamous cell carcinoma were randomized (1:1) to receive nimotuzumab (400mg, iv, weekly, for 6 weeks) combined with CCRT (cisplatin: 40 mg/m 2 , weekly, for 6 weeks; IMRT/VMAT: 45-50.4 Gy/25-28f; high-dose rate brachytherapy: 30-40 Gy, in 8 weeks) or CCRT alone. Nimotuzumab combined with CCRT showed significant ORR improvement, longer trend in PFS and good safety in the treatment of LACC patients."

Clinical • Metastases • P3 data • Cervical Cancer • Oncology • Squamous Cell Carcinoma • EGFR

Nimotuzumab combined with gemcitabine versus gemcitabine in K-RAS wild-type locally advanced or metastatic pancreatic cancer: A prospective, randomized-controlled, double-blinded, multicenter, and phase III clinical trial. (ASCO 2022) - "Nimotuzumab combined with gemcitabine increases OS and PFS in patients with K-Ras wild-type locally advanced or metastatic pancreatic cancer, particularly for those without treatment of biliary obstruction. The safety profile of nimotuzumab is similar to placebo."

Clinical • Late-breaking abstract • P3 data • Gastrointestinal Cancer • Hematological Disorders • Hepatology • Leukopenia • Neutropenia • Oncology • Pancreatic Cancer • Solid Tumor • Thrombocytopenia • KRAS

Paired Agent Imaging to Evaluate the Improvement of Affinity-Matured Nimotuzumab K4 and K5 Variants as EGFR-Detecting Optical Imaging Agents. (PubMed, Mol Pharm) - "Near-infrared fluorescent imaging was used to quantitate the relative amount of each antibody present in tumors and organs. Paired agent imaging allowed us to detect differences in in vivo fluorescence between K4, K5, and nimotuzumab, where K5 had the highest accumulation in the tumor, followed by K4 and nimotuzumab."

Journal • Oncology • EGFR