Meiyouheng (becotatug vedotin) / Lepu Biopharma - LARVOL DELTA

A Phase II, Prospective, Single-arm, Exploratory Study of Becotatug vedotin plus pucotenlimab as Neoadjuvant Therapy for Patients with Resectable, Locally Advanced, EGFR-Positive Esophageal Squamous Cell Carcinoma (ESMO 2026) - No abstract available

Clinical • Metastases • P2 data • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma • EGFR

Becotatug vedotin in combination with pucotenlimab and bevacizumab is being investigated in EGFR‑positive recurrent glioblastoma : a single‑arm, single‑center, exploratory phase II trial (ESMO 2026) - No abstract available

Clinical • Combination therapy • P2 data • Brain Cancer • Glioblastoma • Oncology • Solid Tumor • EGFR

Becotatug vedotin plus pucotenlimab as second-line therapy in patients with advanced biliary tract cancer: A phase II exploratory study. (ESMO 2026) - No abstract available

Clinical • Metastases • P2 data • Biliary Cancer • Biliary Tract Cancer • Oncology • Solid Tumor

Becotatug Vedotin (MRG003) for unresectable locally advanced or metastatic squamous-dominant urothelial malignancies: a prospective, single-arm, open-label, phase II study (ESMO 2026) - No abstract available

Clinical • Metastases • P2 data • Oncology • Urothelial Cancer

First Interim Safety analysis of GORTEC 2024-03 IDEAL: randomized phase II trial of induction treatment anti–PD-1 pucotenlimab (HX008) plus EGFR-ADC (becotatug vedotin (MRG003) versus EGFR-ADC alone followed by chemoradiotherapy in locally advanced head and neck squamous cell carcinoma (ESMO 2026) - No abstract available

ADC • Clinical • Metastases • P2 data • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • EGFR

The efficacy and safety of becotatug vedotin and pucotenlimab in EGFR-positive unresectable anaplastic/ poorly differentiated thyroid cancer: preliminary results from a phase II clinical trial (ESMO 2026) - No abstract available

Clinical • P2 data • Oncology • Solid Tumor • Thyroid Gland Carcinoma • EGFR

Phase Ⅲ Clinical Study on the Efficacy and Safety of SBRT Combined With Vibecotamab in EGFR-Positive Metastatic Tumor Patients With Oligometastases (ChiCTR) - P3 | N=200 | Recruiting | Sponsor: Fifth Affiliated Hospital, Sun Yat-Sen University; Fifth Affiliated Hospital, Sun Yat-Sen University

New P3 trial • Oncology • Solid Tumor • EGFR

A Study to Evaluate the Efficacy and Safety of MRG003 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck (clinicaltrials.gov) - P2 | N=70 | Completed | Sponsor: Lepu Biopharma Co., Ltd. | Recruiting ➔ Completed | N=116 ➔ 70

Enrollment change • Trial completion • Head and Neck Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

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=90 | Recruiting | Sponsor: West China Hospital | Not yet recruiting ➔ Recruiting | Trial completion date: Jun 2029 ➔ Dec 2029 | Initiation date: Feb 2026 ➔ Jul 2026 | Trial primary completion date: Oct 2028 ➔ Dec 2028

Checkpoint inhibition • Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date • Head and Neck Cancer • Oncology • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Becotatug Vedotin for Recurrent/Metastatic Nasopharyngeal Carcinoma (Magic-M001): A Multicenter, Randomized Trial. (PubMed, Ann Oncol) - "Among patients with heavily pretreated and immunotherapy-exposed recurrent or metastatic NPC, becotatug vedotin significantly improved ORR and PFS compared with chemotherapy, with comparable toxicity and encouraging but immature OS results."

Journal • Nasopharyngeal Carcinoma • Oncology • Solid Tumor • EGFR

MH-Penile-002: a phase II, prospective, single-arm trial of neoadjuvant anti-EGFR antibody-drug conjugate plus PD-1 inhibitor in penile cancer with challenging penile preservation or regional lymph node metastasis. (PubMed, Future Oncol) - P2 | "This single-center, prospective, single-arm, phase II trial evaluates the efficacy and safety of neoadjuvant Becotatug Vedotin plus Pucotenlimab in EGFR-expressing PSCC patients with challenging penile preservation or regional lymph node metastasis. The study plans to enroll 60 patients with EGFR-expressing PSCC. Clinical trial registration: www.clinicaltrials.gov identifier is NCT07518979."

Journal • P2 data • Genito-urinary Cancer • Oncology • Penile Cancer • Solid Tumor • Squamous Cell Carcinoma • EGFR

A Study of Becotatug Vedotin Combined With Pucotenlimab in the Treatment of EGFR-Positive Advanced Penile Cancer (clinicaltrials.gov) - P2 | N=20 | Recruiting | Sponsor: Fudan University | Not yet recruiting ➔ Recruiting | Initiation date: May 2026 ➔ Sep 2026

Enrollment open • IO biomarker • Trial initiation date • Genito-urinary Cancer • Oncology • Penile Cancer • Solid Tumor • EGFR

A Study to Evaluate the Efficacy and Safety of MRG003 in Patients With EGFR-Positive Advanced Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=87 | Completed | Sponsor: Lepu Biopharma Co., Ltd. | Recruiting ➔ Completed

Trial completion • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

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

MRG003-010: A Study to Evaluate MRG003 vs Cetuximab/Methotrexate in in the Treatment of Patients With RM-SCCHN (clinicaltrials.gov) - P3 | N=180 | Recruiting | Sponsor: Lepu Biopharma Co., Ltd. | Not yet recruiting ➔ Recruiting | Trial completion date: Dec 2025 ➔ Dec 2027 | Trial primary completion date: Aug 2025 ➔ Dec 2027

Enrollment open • Trial completion date • Trial primary completion date • Head and Neck Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

A Study of MRG003 in the Treatment of EGFR-positive Unresectable, Locally Advanced or Metastatic Biliary Tract Cancer (clinicaltrials.gov) - P2 | N=15 | Completed | Sponsor: Lepu Biopharma Co., Ltd. | Recruiting ➔ Completed | N=80 ➔ 15

Enrollment change • Trial completion • Biliary Cancer • Biliary Tract Cancer • Oncology • Solid Tumor • EGFR

A Study to Evaluate the Efficacy and Safety of MRG003 in Patients With Advanced Gastric Cancer. (clinicaltrials.gov) - P2 | N=6 | Terminated | Sponsor: Lepu Biopharma Co., Ltd. | N=60 ➔ 6 | Recruiting ➔ Terminated; Study terminated due to sponsor decision

Enrollment change • Trial termination • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Oncology • Solid Tumor • EGFR • HER-2

A prospective, single-arm, multicenter exploration of the treatment of EGFR-positive, unresectable, recurrent or metastatic squamous cell carcinoma of the urogenital system (urethra, penis, kidney, ureter, bladder, etc.) with at least one line of systemic chemotherapy using durvalumab (EGFR-ADC) in combination with pembrolizumab (PD-1) (ChiCTR) - P=N/A | N=28 | Not yet recruiting | Sponsor: Zhejiang Cancer Hospital; Zhejiang Cancer Hospital

New trial • Oncology • Squamous Cell Carcinoma • Urology • EGFR

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

Becotatug Vedotin Plus Pucotenlimab and Capecitabine Followed by Concurrent Chemoradiotherapy-Immunotherapy for Locally Advanced Squamous Cell Carcinoma of the Anal Canal (clinicaltrials.gov) - P2 | N=34 | Not yet recruiting | Sponsor: Wang Xin

New P2 trial • Anal Carcinoma • Oncology • Squamous Cell Carcinoma • EGFR

Becotatug Vedotin Plus Pucotenlimab and Platinum Chemotherapy in Locally Advanced Epidermal Growth Factor Receptor (EGFR)-Positive Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: Xuekui Liu

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

PROBE: Protein-Matched ADC or PDC Umbrella Trial in Advanced Pancreatic and Breast Cancer (clinicaltrials.gov) - P2 | N=225 | Not yet recruiting | Sponsor: Fudan University

New P2 trial • Breast Cancer • HER2 Positive Breast Cancer • Oncology • Pancreatic Cancer • Solid Tumor • ER • PGR

MRG003-C001: A Study of MRG003 in the Treatment of Patients With EGFR-positive Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=18 | Recruiting | Sponsor: Lepu Biopharma Co., Ltd. | Trial completion date: Jul 2025 ➔ Aug 2027 | Trial primary completion date: May 2025 ➔ Aug 2027

Trial completion date • Trial primary completion date • Head and Neck Cancer • Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • EGFR

Becotatug Vedotin Combined With Pucotenlimab in Platinum- and Immunotherapy-Resistant Recurrent or Metastatic Nasopharyngeal Carcinoma. (PubMed, J Clin Oncol) - P1/2 | "To our knowledge, we report the first trial combining an ADC with immunotherapy for platinum and anti-PD-1/PD-L1-resistant NPC. BV plus pucotenlimab yielded a notable ORR with exceptionally durable responses and substantially prolonged PFS, alongside manageable toxicities. This regimen may offer a promising anti-PD-1 rechallenge strategy in this population, which is being confirmed in an ongoing, multicenter, randomized controlled, phase III study."

Journal • Dermatology • Hematological Disorders • Nasopharyngeal Carcinoma • Oncology • Pruritus • Solid Tumor

Neoadjuvant Presurgical Becotatug Vedotin (MRG003) Plus Pucotenlimab (HX008) in Oral Cavity Squamous Cell Carcinoma (clinicaltrials.gov) - P2 | N=32 | Not yet recruiting | Sponsor: Sun Yat-sen University

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