RC48-ADC

Phase 3Small molecule

RRemeGen Co., Ltd.

RC48-ADC is one of 111 small molecule programs targeting Bladder Cancer. It is currently in Phase 3.

Indications

Total Trials

Active Trials

110

Competitors

Pipeline

Status by Indication[3][1]

Indication

Bladder CancerNot yet recruiting

Urothelial CarcinomaRecruiting

Esophageal AdenocarcinomaRecruiting

Bladder CancerPhase 2

Not yet recruiting

Urothelial CarcinomaPhase 3

Recruiting

Esophageal AdenocarcinomaPhase 2

Recruiting

Competition

Competitive Landscape

118 competitors in Bladder Cancer

#DrugCompanyPhaseTrials

Gemzar

Johnson & Johnson

Phase 3

52 2

Keytruda

Merck & Co.

Phase 3

27 3

Opdivo

Bristol-Myers Squibb

Phase 3

20 4

Platinol

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

Phase 3

57 5

Tecentriq

Roche

Phase 3

16 6

Imfinzi

AstraZeneca

Phase 3

16 7

Trexall

Jazz Pharmaceuticals

Phase 3

12 8

Padcev

Pfizer

Phase 3

8 9

Imjudo

AstraZeneca

Phase 3

8 10

Gemzar

GGynecologic Oncology Group

Phase 3

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

Timeline

Expected Milestones

Q3 2027

Phase 2Not yet recruiting

Bladder Cancer

NCT05356351

Q2 2028

Phase 3Recruiting

Urothelial Carcinoma

NCT05302284

Clinical

Trials by Indication[1]

Bladder Cancer5 trials

A Clinical Study of RC48-ADC Combined With Triplizumab For Treatment of Myometrial Invasive Bladder Cancer

Unknown status·TThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School·Phase 2·NCT05016973·25 enrolled

A Study of RC48-ADC Combined With AK104 For Perioperative Treatment of Muscle-Invasive Bladder Cancer

Unknown status·—·Phase 2·NCT06074484·36 enrolled

RC48-ADC in Adjuvant/Salvage Treatment of HER2 Positive Non-muscle-invasive Bladder Cancer

Not yet recruiting·WWest China Hospital·Phase 2·NCT05996952·77 enrolled

Show 2 more trials

An Open-label, Single-arm, Multicenter Phase II Clinical Study： Evaluating RC48-ADC Combined With Triplizumab in the Neoadjuvant Treatment of Her2-positive Muscle-invasive Bladder Cancer

Not yet recruiting·TTianjin Medical University Cancer Institute and Hospital·Phase 2·NCT05356351·30 enrolled

A Study of RC48-ADC Combined With JS001 For Perioperative Treatment of Muscle-Invasive Bladder Cancer

Unknown status·RRemeGen Co., Ltd.·Phase 2·NCT05297552·40 enrolled

Breast Cancer3 trials

A Study of RC48-ADC for the Treatment of HER2-expression Metastatic Breast Cancer With Abnormal Activation of PAM Pathway

Unknown status·—·Phase 2·NCT05331326·64 enrolled

A Study of RC48-ADC Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer With or Without Liver Metastases

Unknown status·RRemeGen Co., Ltd.·Phase 2/3·NCT03500380·301 enrolled

A Study of RC48-ADC for the Treatment of Locally Advanced or Metastatic Breast Cancer With Low Expression of HER2

Unknown status·RRemeGen Co., Ltd.·Phase 3·NCT04400695·366 enrolled

Gastric Cancer3 trials

A Study of RC48-ADC in Local Advanced or Metastatic Gastric Cancer Subjects With the Overexpression of HER2

Completed·RRemeGen Co., Ltd.·Phase 2·NCT03556345·127 enrolled

To Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Disitamab Vedotin Combined With RC98 in the Treatment of Subjects With HER2-expressing Locally Advanced or Metastatic Gastric Cancer (Including AEG)

Unknown status·RRemeGen Co., Ltd.·Phase 1·NCT05514158·24 enrolled

A Study of RC48-ADC in Local Advanced or Metastatic Gastric Cancer With the HER2-Overexpression

Unknown status·RRemeGen Co., Ltd.·Phase 3·NCT04714190·351 enrolled

Metastatic Urothelial Cancer2 trials

A Open-label, Single-arm, Multicenter, Phase II Study of RC48-ADC to Evaluate the Efficacy and Safety of Subjects With HER2 Overexpressing Locally Advanced or Metastatic Urothelial Cancer

Completed·RRemeGen Co., Ltd.·Phase 2·NCT03809013·64 enrolled

A Study of RC48-ADC in Subjects With HER2-negative Locally Advanced or Metastatic Urothelial Cancer

Completed·RRemeGen Co., Ltd.·Phase 2·NCT04073602·19 enrolled

Biliary Tract Cancer2 trials

A Study of RC48-ADC in Subjects With HER2 Overexpressed Metastatic Biliary Tract Cancer

Unknown status·RRemeGen Co., Ltd.·Phase 2·NCT04329429·57 enrolled

RC48-ADC Combinatioed Envolizumab in Locally Advanced or Metastatic Biliary Tract Cancer With Positive HER-2

Unknown status·JJiangsu Cancer Institute & Hospital·Phase 2·NCT05417230·29 enrolled

9 more indications

Urothelial Carcinoma2 trials

A Study of RC48-ADC Combined With Toripalimab For First-line Treatment of Urothelial Carcinoma

Recruiting·RRemeGen Co., Ltd.·Phase 3·NCT05302284·452 enrolled

A Study of RC48-ADC Combined With Cadonilimab（AK104）in the Treatment of HER2-expression Locally Advanced or Metastatic Urothelial Carcinoma

Recruiting·SShanxi Province Cancer Hospital·Phase 2·NCT06178601·36 enrolled

Malignancies1 trial

A Study of RC48-ADC for the Treatment of HER2-expressing Gynecological Malignancies

Unknown status·RRemeGen Co., Ltd.·Phase 2·NCT04965519·120 enrolled

Phase II1 trial

Phase II Study of RC48-ADC in Treating Patients With Salivary Gland Tumors Expressing HER2

Unknown status·PPeking Union Medical College Hospital·Phase 2·NCT05601401·10 enrolled

Urothelial Cancer1 trial

A Phase II Study of RC48-ADC in Subjects With HER2 Positive Metastatic or Unresectable Urothelial Cancer

Completed·RRemeGen Co., Ltd.·Phase 2·NCT03507166·43 enrolled

HER2-positive Advanced Malignant Solid Tumors1 trial

A Study of RC48-ADC in Subjects With HER2-Positive Advanced Malignant Solid Tumors

Completed·RRemeGen Co., Ltd.·Phase 1·NCT02881138·24 enrolled

Esophageal Adenocarcinoma1 trial

RC48-ADC Combined With S-1 for First-line Treatment of Advanced Gastroesophageal Adenocarcinoma With Moderate Expression of HER2

Recruiting·—·Phase 1/2·NCT05403242·42 enrolled

Advanced Malignant Solid Tumors1 trial

Study of RC48-ADC Administered Intravenously to Subjects With HER2-Positive in Advanced Malignant Solid Tumors

Completed·RRemeGen Co., Ltd.·Phase 1·NCT02881190·57 enrolled

Melanoma1 trial

A Study of RC48-ADC in Advanced Melanoma Subjects With HER2 Variant (Mutation, Amplification, Overexpression)

Unknown status·RRemeGen Co., Ltd.·Phase 2·NCT05135715·50 enrolled

Metastasis1 trial

A Study of RC48-ADC Combined With Pyrotinib For Treatment of Local Advanced or Metastasis NSCLC With HER2 Mutation

Unknown status·RRemeGen Co., Ltd.·Phase 1/2·NCT05745740·26 enrolled

Sources

References

[1]
ClinicalTrials.gov — 25 trial records for RC48-ADC. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — RC48-ADC compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for RC48-ADC. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — RemeGen Co., Ltd. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: RRemeGen Co., Ltd.

RC48-ADC

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2027

Q2 2028

Trials by Indication[1]

Bladder Cancer5 trials

Breast Cancer3 trials

Gastric Cancer3 trials

Metastatic Urothelial Cancer2 trials

Biliary Tract Cancer2 trials

Urothelial Carcinoma2 trials

Malignancies1 trial

Phase II1 trial

Urothelial Cancer1 trial

HER2-positive Advanced Malignant Solid Tumors1 trial

Esophageal Adenocarcinoma1 trial

Advanced Malignant Solid Tumors1 trial

Melanoma1 trial

Metastasis1 trial

References

Drug Info

Quick Facts

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