Meiyouheng (becotatug vedotin) / Lepu Med - LARVOL DELTA

Becotatug Vedotin Combined With Cetuximab in the Later-line Treatment of Metastatic RAS Wild-type Colorectal Cancer (clinicaltrials.gov) - P2 | N=31 | Not yet recruiting | Sponsor: Fudan University

New P2 trial • Colorectal Cancer • Oncology • Solid Tumor • BRAF • EGFR • MSI • PD-1 • PD-L1

Becotatug vedotin vs. chemotherapy in pre-heavily treated advanced nasopharyngeal carcinoma: A randomized, controlled, multicenter, open-label study. (ASCO 2025) - P2 | " Eligible pts with R/M NPC had failed ≥2 lines of systemic chemotherapy and PD-(L)1 inhibitor, and were randomized to receive MRG003 (2.3 mg/kg, d1, iv, Q3W) or chemotherapy (capecitabine 1000 mg/m2, po, twice daily, d1-14, Q3W; or docetaxel 75 mg/m2, iv, d1, Q3W). As the first ADC clinical study targeting heavily pretreated R/M NPC, becotatug vedotin demonstrated statistically and clinically meaningful benefits while maintaining a manageable safety profile in this population. This study will lead to a paradigm shift in the treatment of R/M NPC. Sponsor: Lepu Biopharma Co., Ltd."

Clinical • Late-breaking abstract • Metastases • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

Updated long term efficacy results of phase II study for becotatug vedotin combined with pucotenlimab in recurrent or metastatic nasopharyngeal carcinoma (R/M-NPC) (ESMO 2025) - "It may provide an efficacious treatment option for R/M-NPC pts who had failed anti-PD-(L)1 and platinum-based therapy. The efficacy and safety of MRG003 combined with HX008 in NPC is currently undergoing further investigation in randomized controlled clinical trials."

Clinical • Metastases • P2 data • Nasopharyngeal Carcinoma • Oncology • Solid Tumor • EGFR

Recent highlights and breakthroughs in immunotherapy for head and neck cancers. (PubMed, Curr Opin Oncol) - "Recent advances highlight a rapid surge in positive immunotherapy trials across different head and neck cancer entities, with clinical benefit observed both when immune checkpoint inhibitors are moved earlier in the disease course and when they are combined with agents targeting resistance mechanisms or enabling more precise drug delivery to tumors."

IO biomarker • Journal • Head and Neck Cancer • Nasopharyngeal Carcinoma • Non-melanoma Skin Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer • Thyroid Gland Anaplastic Carcinoma • Thyroid Gland Carcinoma • BRAF

RearTurbo: Becotatug Vedotin as Adjuvant Therapy For High-risk Nasopharyngeal Carcinoma (clinicaltrials.gov) - P2 | N=218 | Not yet recruiting | Sponsor: Kai Hu | Trial completion date: Dec 2032 ➔ Apr 2033 | Trial primary completion date: Dec 2029 ➔ Apr 2030

Trial completion date • Trial primary completion date • Head and Neck Cancer • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

Efficacy and Safety of SBRT Combined With Becotatug Vedotin in EGFR-Positive Metastatic Tumor Patients With Oligometastases (clinicaltrials.gov) - P3 | N=200 | Not yet recruiting | Sponsor: Ming-Yuan Chen

New P3 trial • Oncology • EGFR

Becotatug Vedotin Plus Sintilimab in Locoregionally Advanced NPC (clinicaltrials.gov) - P3 | N=266 | Recruiting | Sponsor: First Affiliated Hospital of Guangxi Medical University

New P3 trial • Head and Neck Cancer • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

Becotatug Vedotin: First Approval. (PubMed, Drugs) - "In October 2025, becotatug vedotin received its first approval in China for the treatment of adult patients with recurrent/metastatic nasopharyngeal carcinoma who have failed at least two lines of systemic chemotherapy and programmed death-1 (PD-1)/programmed death-1 ligand (PD-L1) inhibitor therapy. This article summarizes the milestones in the development of becotatug vedotin leading to this first approval for nasopharyngeal cancer."

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

A Single-arm, Multicenter Clinical Study of Becotatug Vedotin Combined With Zimberelimab in the Treatment of Recurrent and Metastatic Cervical Cancer, Vulvar Cancer and Vaginal Cancer (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

New P2 trial • Cervical Cancer • Gynecologic Cancers • Oncology • Solid Tumor • Vaginal Cancer • Vulvar Cancer

RT023, a first-in-class CEACAM5/EGFR targeted bispecific antibody drug conjugate (ADC) in colorectal cancer (CRC) (AACR 2026) - "EGFR antibodies like cetuximab are standard first-line therapy for colorectal cancer (CRC) patients with wild-type KRAS, but are less effective in those with KRAS mutations, creating an unmet clinical need. ADCs targeting CEACAM5 or EGFR, such as M9140 and MRG003, are under clinical development for CRC; however, single-target ADCs have shown limited efficacy, likely due to variable antigen expression among patients... RT023, with its unique bispecific design and differentiated features in affinity, linker-payload, has shown promising potential as a first-in-class ADC candidate for CRC treatment. Preclinical discovery studies have revealed favorable efficacy and toxicity profiles, supporting advancing RT023 into first-in-human studies."

ADC • Bispecific • First-in-human • Colorectal Cancer • Oncology • Solid Tumor • CEACAM5 • KRAS

MRG008: A novel EGFR and 5T4 bispecific antibody-drug conjugate (ADC) with potent antitumor activity in preclinical studies (AACR 2026) - "EGFR (also known as HER1) is an epidermal growth factor receptor with tyrosine kinase activity implicated in both tumorigenesis and tumor progression, and its validity as a therapeutic target for ADC has been clinically confirmed, as exemplified by our approved drug MRG003. MRG008 is a promising dual-targeted ADC with potent anti-tumor efficacy for the treatment of NSCLC. These preclinical findings provide a strong rationale for advancing MRG008 into IND-enabling and clinical studies."

ADC • Bispecific • Preclinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • TPBG

Engineering and preclinical development of a differentiated EGFR/PDL1 bispecific ADC for the targeted therapy of solid tumors (AACR 2026) - "Importantly, no Immunotoxicity was observed on PDL1+ human antigen‑presenting cells. In vivo efficacy studies demonstrated that the lead bsADC achieved superior antitumor activity compared with MRG003 analog (an anti-EGFR ADC) and the clinical-stage PDL1V analog (an anti-PDL1 ADC) in multiple CDX models."

ADC • Bispecific • IO biomarker • Preclinical • Oncology • Solid Tumor • EGFR • PD-L1

TSEMPRMSGC: The Safety and Efficacy of MRG003 With or Without Putrelimab in Recurrent or Metastatic Salivary Gland Cancer: a Single-center, Open-label Cohort Study (clinicaltrials.gov) - P2 | N=68 | Not yet recruiting | Sponsor: Ji Dongmei

IO biomarker • New P2 trial • Oncology • Salivary Gland Cancer

Becotatug vedotin, MRG003, in previously treated recurrent or metastatic nasopharyngeal carcinoma: A multicenter, single-arm, phase IIa trial. (PubMed, Med) - P2 | "MRG003 demonstrated promising efficacy and manageable safety in pretreated R/M NPC patients. This is also the first long-term evaluation of an EGFR-targeted ADC in this population."

Journal • P2a data • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

Neoadjuvant Becotatug Vedotin Plus Pucotenlimab and Cisplatin for Locally Advanced Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: Sir Run Run Shaw Hospital

New P2 trial • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

A Study to Evaluate the Efficacy and Safety of MRG003 in Patients With Recurrent Metastatic Nasopharyngeal Carcinoma (clinicaltrials.gov) - P2 | N=238 | Active, not recruiting | Sponsor: Shanghai Miracogen Inc. | Recruiting ➔ Active, not recruiting | Trial completion date: Feb 2025 ➔ Dec 2026

Enrollment closed • Trial completion date • Head and Neck Cancer • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

A Phase II Clinical Trial of Anti-EGFR Antibody-drug Conjugate (ADC) Combined With or Without Immune Checkpoint Inhibitors in the Neoadjuvant Treatment of Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - P2 | N=120 | Not yet recruiting | Sponsor: West China Hospital

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

Pucotenlimab Combined With Becotatug Vedotin in Advanced Cutaneous Squamous Cell Carcinoma (clinicaltrials.gov) - P2 | N=38 | Not yet recruiting | Sponsor: Fudan University

New P2 trial • Non-melanoma Skin Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

RearTurbo: Becotatug Vedotin as Adjuvant Therapy For High-risk Nasopharyngeal Carcinoma (clinicaltrials.gov) - P2 | N=227 | Not yet recruiting | Sponsor: Kai Hu | N=150 ➔ 227 | Trial completion date: Dec 2031 ➔ Dec 2032

Enrollment change • Trial completion date • Head and Neck Cancer • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

Efficacy and Safety of Becotatug Vedotin (EGFR ADC) plus Pucotenlimab and Cisplatin as Neoadjuvant Therapy for LA-HNSCC (ChiCTR) - P=N/A | N=30 | Not yet recruiting | Sponsor: Sir Run Run Shaw Hospital, Zhejiang University School of Medicine; Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

New trial • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

MRG003 Combined With Immunotherapy in Recurrent/Metastatic Nasopharyngeal Carcinoma: A Phase II Clinical Trial (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: West China Hospital

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

Becotatug Vedotin in Patients with Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck: A Multicenter, Phase IIa Trial. (PubMed, Clin Cancer Res) - P2 | "Becotatug vedotin demonstrated promising antitumor activity with a manageable safety profile in previously heavilytreated R/M SCCHN, particularly the recommended dose of 2.3 mg/kg in patients who had failed platinum-based chemotherapy and PD-1/PD-L1 inhibitors (≤2 prior lines of therapy)."

Journal • P2a data • Constipation • Dermatology • Gastroenterology • Gastrointestinal Disorder • Head and Neck Cancer • Hematological Disorders • Oncology • Pruritus • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Magic-C002: A Study of MRG003 in Combination With Pucotenlimab Versus Chemotherapy in the Treatment of Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma (clinicaltrials.gov) - P3 | N=446 | Recruiting | Sponsor: Shanghai Miracogen Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Head and Neck Cancer • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

MRG003 Induction and Capecitabine Maintenance With PD-1 in Locally Recurrent NPC (clinicaltrials.gov) - P2 | N=25 | Not yet recruiting | Sponsor: Fujian Cancer Hospital

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

RearTurbo: Becotatug Vedotin as Adjuvant Therapy For High-risk Nasopharyngeal Carcinoma (clinicaltrials.gov) - P2 | N=150 | Not yet recruiting | Sponsor: Kai Hu

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