MRG003

Phase 3Small molecule

MRG003 is one of 106 small molecule programs targeting Head and Neck Squamous Cell Carcinoma. It is currently in Phase 3.

Indications

Total Trials

Active Trials

105

Competitors

Pipeline

Status by Indication[3][1]

Indication

Head and Neck Squamous Cell CarcinomaNot yet recruiting

Small Cell Lung Cancer ( SCLC )Recruiting

Squamous Cell Carcinoma of the Head and NeckRecruiting

Biliary Tract NeoplasmsEnrolling by invitation

Recurrent or Metastatic Nasopharyngeal CarcinomaRecruiting

Squamous Cell CancerNot yet recruiting

Squamous Cell CarcinomaNot yet recruiting

Head and Neck Squamous Cell CarcinomaPhase 2

Not yet recruiting

Small Cell Lung Cancer ( SCLC )Preclinical

Recruiting

Squamous Cell Carcinoma of the Head and NeckPhase 3

Recruiting

Biliary Tract NeoplasmsPhase 2

Enrolling by invitation

Recurrent or Metastatic Nasopharyngeal CarcinomaPhase 3

Recruiting

Squamous Cell CancerPhase 2

Not yet recruiting

Squamous Cell CarcinomaPhase 2

Not yet recruiting

Competition

Competitive Landscape

112 competitors in Head and Neck Squamous Cell Carcinoma

#DrugCompanyPhaseTrials

Platinol

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Phase 3

36 2

Erbitux

IImclone

Phase 3

27 3

Beyfortus

BeiGene

Phase 3

8 4

Imfinzi

AstraZeneca

Phase 3

6 5

Taxotere

AAvyxa

Phase 3

17 6

Ibrance

Pfizer

Phase 3

4 7

Tuoyi

CCoherus Oncology, Inc.

Phase 3

6 8

Theraplaza

BBiotech Pharmaceutical Co., Ltd.

Phase 3

4 9

Adrucil

EElorac, Inc.

Phase 3

4 10

Gilotrif

Boehringer Ingelheim

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Active, not recruiting

Recurrent or Metastatic Nasopharyngeal Carcinoma

NCT05126719

Q4 2027

Phase 3Recruiting

Squamous Cell Carcinoma of the Head and Neck

NCT05751512

Q2 2029

Phase 2Not yet recruiting

Head and Neck Squamous Cell Carcinoma

NCT07677475

Q4 2029

Phase 2Not yet recruiting

Squamous Cell Cancer

NCT06959108

PreclinicalRecruiting

Small Cell Lung Cancer ( SCLC )

NCT07874581

Phase 2Recruiting

Nasopharyngeal Carcinoma

NCT07331428

Clinical

Trials by Indication[1]

Recurrent or Metastatic Nasopharyngeal Carcinoma2 trials

A Randomized, Open-label, Multi-center, Phase III Study of MRG003 in Combination With Pucotenlimab Versus Chemotherapy in the Treatment of Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma

Recruiting·SShanghai Miracogen Inc.·Phase 3·NCT06976190·446 enrolled

An Open-Label, Multi-Center Phase II Clinical Study to Evaluate the Efficacy and Safety of MRG003 in Patients With Recurrent Metastatic Nasopharyngeal Carcinoma

Active, not recruiting·SShanghai Miracogen Inc.·Phase 2·NCT05126719·238 enrolled

Squamous Cell Cancer1 trial

Clinical Trial Comparing Induction Treatment With EGFR-ADC MRG003 Alone or in Combination With the Anti PD1 Pucotenlimab, Followed by Radiochemotherapy in Locally Advanced Squamous Cell Cancers of the Head and Neck

Not yet recruiting·GGroupe Oncologie Radiotherapie Tete et Cou·Phase 2·NCT06959108·106 enrolled

Squamous Cell Carcinoma1 trial

MRG003 Plus HX008 as First-Line Treatment for EGFR-Positive Locally Advanced or Metastatic Penile Squamous Cell Carcinoma

Not yet recruiting·JJiyan Liu·Phase 1·NCT07054307·10 enrolled

Biliary Tract Neoplasms1 trial

A Single-arm, Multicenter, Open-label, Phase II Clinical Study of Vedotin for Injection as Second-line or Later Treatment for Advanced Biliary Tract Cancer.

Enrolling by invitation·JJiangmen Central Hospital·Phase 2·NCT07890311·30 enrolled

Nasopharyngeal Carcinoma1 trial

Efficacy and Safety of MRG003 With PD-1 Induction Followed by Capecitabine and PD-1 Maintenance as First-line Treatment in Locally Recurrent Nasopharyngeal Carcinoma

Recruiting·FFujian Cancer Hospital·Phase 2·NCT07331428·25 enrolled

8 more indications

Small Cell Lung Cancer ( SCLC )1 trial

Effectiveness and Safety of MRG003 (Becotatug Vedotin) in Patients With Relapsed Small Cell Lung Cancer: A Single-Center, Single-Arm, Exploratory Study

Recruiting·SShanghai Pulmonary Hospital, Shanghai, China·Preclinical·NCT07874581·52 enrolled

Squamous Cell Carcinoma of Head and Neck1 trial

An Open-Label, Single Arm, Multi-Center Phase II Clinical Study to Evaluate the Efficacy and Safety of MRG003 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck.

Completed·SShanghai Miracogen Inc.·Phase 2·NCT04868162·70 enrolled

Metastatic Biliary Tract Cancer1 trial

An Open-label, Single-arm, Multi-center, Phase II Clinical Study of MRG003 in the Treatment of Patients With EGFR-positive Unresectable, Locally Advanced or Metastatic Biliary Tract Cancer

Completed·SShanghai Miracogen Inc.·Phase 2·NCT04838964·15 enrolled

Advanced or Metastatic Gastric Cancer1 trial

A Phase II Clinical Study to Evaluate the Efficacy and Safety of MRG003 in EGFR-Positive, HER2-Negative Advanced Gastric Cancer.

Terminated·SShanghai Miracogen Inc.·Phase 2·NCT05188209·6 enrolled

Carcinoma, Non-Small-Cell Lung1 trial

An Open-Label, Multi-Cohort, Multi-center, Non-Randomized, Phase II Clinical Study to Evaluate the Efficacy and Safety of MRG003 in Patients With EGFR-Positive Advanced Non-Small Cell Lung Cancer

Completed·SShanghai Miracogen Inc.·Phase 2·NCT04838548·87 enrolled

Squamous Cell Carcinoma of the Head and Neck1 trial

A Randomized, Open-Label, Multicenter, Phase III Study to Evaluate MRG003 vs Cetuximab/Methotrexate as Second/Third Line of Treatment in Patient With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (RM-SCCHN)

Recruiting·SShanghai Miracogen Inc.·Phase 3·NCT05751512·180 enrolled

Solid Tumor1 trial

An Open-Label, Dose-Finding, Phase I Study in Solid Tumors.

Completed·SShanghai Miracogen Inc.·Phase 1·NCT04868344·61 enrolled

Head and Neck Squamous Cell Carcinoma1 trial

MRG003 (Becotatug Vedotin) Plus Toripalimab Versus Toripalimab as Neoadjuvant Therapy for PD-L1-Positive, Resectable, Locally Advanced Head and Neck Squamous Cell Carcinoma: A Multicenter, Prospective, Randomized, Controlled Phase II Trial

Not yet recruiting·DDongguan People's Hospital·Phase 2·NCT07677475·65 enrolled

Sources

References

[1]
ClinicalTrials.gov — 14 trial records for MRG003. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — MRG003 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for MRG003. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Shanghai Miracogen Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: SShanghai Miracogen Inc.

MRG003

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q4 2027

Q2 2029

Q4 2029

Trials by Indication[1]

Recurrent or Metastatic Nasopharyngeal Carcinoma2 trials

Squamous Cell Cancer1 trial

Squamous Cell Carcinoma1 trial

Biliary Tract Neoplasms1 trial

Nasopharyngeal Carcinoma1 trial

Small Cell Lung Cancer ( SCLC )1 trial

Squamous Cell Carcinoma of Head and Neck1 trial

Metastatic Biliary Tract Cancer1 trial

Advanced or Metastatic Gastric Cancer1 trial

Carcinoma, Non-Small-Cell Lung1 trial

Squamous Cell Carcinoma of the Head and Neck1 trial

Solid Tumor1 trial

Head and Neck Squamous Cell Carcinoma1 trial

References

Drug Info

Quick Facts

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