Trastuzumab Rezetecan

Phase 3

PPeking Union Medical College Hospital

Trastuzumab Rezetecan is one of 130 therapeutic programs targeting Gastric Adenocarcinoma. It is currently in Phase 3.

Indications

Total Trials

Active Trials

129

Competitors

Pipeline

Status by Indication[2][1]

Indication

Gastric AdenocarcinomaNot yet recruiting

Ovarian CancerNot yet recruiting

NSCLCNot yet recruiting

Lung Cancer (NSCLC)Not yet recruiting

HER2 + Breast CancerRecruiting

Biliary Tract NeoplasmsRecruiting

UTUCRecruiting

HER 2 Positive Advanced Breast CancerRecruiting

Gastric Adenocarcinoma and Gastroesophageal Junction AdenocarcinomaNot yet recruiting

GEJCNot yet recruiting

Gastric AdenocarcinomaPhase 2

Not yet recruiting

Ovarian CancerPhase 2

Not yet recruiting

NSCLCPhase 2

Not yet recruiting

Lung Cancer (NSCLC)Phase 2

Not yet recruiting

HER2 + Breast CancerPhase 3

Recruiting

Biliary Tract NeoplasmsPhase 2

Recruiting

UTUCPhase 2

Recruiting

HER 2 Positive Advanced Breast CancerPhase 2

Recruiting

Gastric Adenocarcinoma and Gastroesophageal Junction AdenocarcinomaPhase 2

Not yet recruiting

GEJCPhase 2

Not yet recruiting

Competition

Competitive Landscape

207 competitors in Ovarian Cancer

#DrugCompanyPhaseTrials

Avastin

Roche

Phase 3

92 2

Gemzar

Johnson & Johnson

Phase 3

33 3

Keytruda

Merck & Co.

Phase 3

28 4

Hycamtin

MMeitheal

Phase 3

26 5

Platinol

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

Phase 3

24 6

Cytoxan

BBaxter Healthcare Corporation

Phase 3

24 7

Imfinzi

AstraZeneca

Phase 3

8 8

Opdivo

Bristol-Myers Squibb

Phase 3

8 9

Adriamycin

Pfizer

Phase 3

8 10

Femara

Novartis

Phase 3

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

Timeline

Expected Milestones

Q2 2028

Phase 2Recruiting

Biliary Tract Neoplasms

NCT07704177

Phase 2Recruiting

Biliary Tract Neoplasms

NCT07670273

Q4 2028

Phase 2Not yet recruiting

Muscle-Invasive Bladder Cancer

NCT07865611

Phase 2Not yet recruiting

GEJC

NCT07817654

Q1 2029

Phase 2Not yet recruiting

Lung Cancer (NSCLC)

NCT07699952

Q3 2029

Phase 2Recruiting

UTUC

NCT07741448

Clinical

Trials by Indication[1]

Ovarian Cancer2 trials

Trastuzumab Rezetecan Plus Bevacizumab in Platinum-Sensitive Recurrent Ovarian Cancer: A Phase II, Multicenter, Single-Arm Study

Not yet recruiting·PPeking University Cancer Hospital & Institute·Phase 2·NCT07843303·53 enrolled

Trastuzumab Rezetecan and Carboplatin With or Without Bevacizumab Versus Investigator's Choice Chemotherapy in Patients With Platinum-sensitive Recurrent Ovarian Cancer: an Open-label, Multicenter, Randomized Controlled Phase II Study

Not yet recruiting·SSun Yat-sen University·Phase 2·NCT07776171·176 enrolled

HER2 + Breast Cancer2 trials

A Single-arm, Exploratory Clinical Study of Sequential Use of Regorafenib in Combination With Pegylated Tyrosine Kinase Inhibitor and Trastuzumab in Combination With Capecitabine as First-line Treatment for Advanced HER2-positive Breast Cancer

Not yet recruiting·FFujian Cancer Hospital·Phase 2·NCT07766772·50 enrolled

Real-world Study of Pyrotinib-containing Regimens in First-line or Second-line Treatment of Advanced HER2-positive Breast Cancer

Recruiting·PPeking University People's Hospital·Approved·NCT07600164·500 enrolled

Biliary Tract Neoplasms2 trials

A Prospective, Open-Label, Multicenter Phase II Study of Trastuzumab Rezetecan Combined With Adebrelimab and Lenvatinib for HER2-Positive or Low-Expression Locally Advanced or Metastatic Biliary Tract Cancer in the Second-Line or Later Setting

Recruiting·PPeking Union Medical College Hospital·Phase 2·NCT07704177·70 enrolled

A Prospective, Open-label, Multicenter Phase II Clinical Study of Rikang Trastuzumab in Combination With Adebrelimab and Lenvatinib for First-line Treatment of HER2-positive or Low-expressing Locally Advanced or Metastatic Biliary Tract Cancer

Recruiting·PPeking Union Medical College Hospital·Phase 2·NCT07670273·70 enrolled

Gastric Adenocarcinoma1 trial

A Dual-Cohort, Exploratory Study of Trastuzumab Rezetecan (SHR-A1811) With or Without Adebrelimab as Neoadjuvant Therapy for Gastric or Gastroesophageal Junction Adenocarcinoma

Not yet recruiting·FFudan University·Phase 2·NCT07912957·62 enrolled

Metastatic Breast Cancer (MBC)1 trial

An Open-Label, Multicenter Clinical Study of Trastuzumab Rezetecan Followed by Pyrotinib in Combination With Fulvestrant and Dalpiciclib in Patients With HR-Positive, HER2-Positive Advanced Breast Cancer

Not yet recruiting·SSun Yat-Sen Memorial Hospital of Sun Yat-Sen University·Phase 3·NCT07892274·226 enrolled

9 more indications

Breast Carcinoma1 trial

Trastuzumab Rezetecan (SHR-A1811) Versus Chemotherapy of Physician's Choice in Patients With HER2-Low Unresectable/Metastatic Breast Cancer Complicated With Visceral Crisis：A Randomized, Prospective, Open-Label Phase II Trial.

Recruiting·CCancer Institute and Hospital, Chinese Academy of Medical Sciences·Phase 2·NCT07203729·184 enrolled

HER 2 Positive Advanced Breast Cancer1 trial

An Open-label, Randomized, Controlled Trial of Trastuzumab Rezetecan Combined With Radiotherapy Versus Trastuzumab Rezetecan in the Treatment of HER2-positive Advanced Breast Cancer With Brain Metastases

Recruiting·HHenan Cancer Hospital·Phase 2·NCT07100600·224 enrolled

Muscle-Invasive Bladder Cancer1 trial

A Prospective, Multicenter, Open-Label Phase II Study of Response-Guided Bladder Preservation With Trastuzumab Rezetecan Plus Adebrelimab and Concurrent Bladder Radiotherapy in Patients With HER2-Expressing Muscle-Invasive Bladder Cancer

Not yet recruiting·TTongji Hospital·Phase 2·NCT07865611·70 enrolled

Non-Small Cell Lung Cancer1 trial

A Randomized, Open-label, Multicenter, Phase II Study of Trastuzumab Rezetecan With Adebrelimab, Trastuzumab Rezetecan Alone and Adebrelimab Alone as Consolidation Therapy in Patients With Unresectable Stage III Non-Small Cell Lung Cancer Harboring HER2 Alterations Without Progression After Definitive Chemoradiotherapy

Not yet recruiting·MMing Chen·Phase 2·NCT07836543·105 enrolled

GEJC1 trial

Prospective, Exploratory Clinical Study of Trastuzumab Combined With Retlirafusp Alfa in Treating HER2 2+/3+ Gastric/Gastroesophageal Junction Adenocarcinoma After First-line Systemic Therapy Failure

Not yet recruiting·HHenan Cancer Hospital·Phase 2·NCT07817654·35 enrolled

Not yet recruiting·YYongsheng Wang·Phase 2·NCT07699952·35 enrolled

UTUC1 trial

An Open-label, Single-arm, Multicenter Phase II Clinical Study to Evaluate Neoadjuvant Gemcitabine Combined With Trastuzumab Rezetecan in HER2-positive Upper Tract Urothelial Carcinoma

Recruiting·ZZhiquan Hu·Phase 2·NCT07741448·54 enrolled

Sources

References

[1]
ClinicalTrials.gov — 17 trial records for Trastuzumab Rezetecan. U.S. National Library of Medicine, National Institutes of Health.
[2]
Open Targets Platform — Drug–disease associations for Trastuzumab Rezetecan. EMBL-EBI & Wellcome Sanger Institute.
[3]
SEC EDGAR — Peking Union Medical College Hospital company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Highest Phase: Phase 3[1]
Company: PPeking Union Medical College Hospital

Trastuzumab Rezetecan

Status by Indication[2][1]

Competitive Landscape

Expected Milestones

Q2 2028

Q4 2028

Q1 2029

Q3 2029

Trials by Indication[1]

Ovarian Cancer2 trials

HER2 + Breast Cancer2 trials

Biliary Tract Neoplasms2 trials

Gastric Adenocarcinoma1 trial

Metastatic Breast Cancer (MBC)1 trial

Breast Carcinoma1 trial

HER 2 Positive Advanced Breast Cancer1 trial

Muscle-Invasive Bladder Cancer1 trial

Non-Small Cell Lung Cancer1 trial

GEJC1 trial

Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma1 trial

NSCLC1 trial

Lung Cancer (NSCLC)1 trial

UTUC1 trial

References

Drug Info

Quick Facts

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