Trastuzumab deruxtecan

Part 1: Bladder, Biliary Tract, Cervical, Endometrial, Ovarian, Pancreatic Cancer, Rare Tumors, Any Tumor Type Excluding Breast, Gastric, Colorectal Cancer

NCT04482309

Q2 2027

ApprovedRecruiting

Anatomic Stage IV Breast Cancer AJCC V8

NCT05376878

Phase 2Recruiting

Gastric Cancer

NCT04379596

PreclinicalRecruiting

Locally Advanced Lung Non-Small Cell Carcinoma

NCT07012031

Q3 2027

Phase 3Active, not recruiting

Locally Advanced or Metastatic Non-Small Cell Lung Cancer

NCT05048797

Q4 2027

PreclinicalRecruiting

Advanced Solid Malignancies

NCT05417594

Clinical

Trials by Indication[1]

Gastric Cancer2 trials

A Phase 1b/2 Multicenter, Open-label, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of Trastuzumab Deruxtecan (T-DXd) Monotherapy and Combinations in Adult Participants With HER2-expressing Gastric Cancer (DESTINY-Gastric-03)

Recruiting· AstraZeneca logo

AstraZeneca·Phase 2·NCT04379596·450 enrolled

A Multicenter, Randomized, Open-Label, Phase 3 Trial of Trastuzumab Deruxtecan (Enhertu®) Plus Chemotherapy Plus or Minus Pembrolizumab Versus Chemotherapy Plus Trastuzumab Plus or Minus Pembrolizumab as First-Line Treatment in Participants With Unresectable, Locally Advanced or Metastatic HER2-Positive Gastric Or Gastroesophageal Junction (GEJ) Cancer (Destiny-Gastric05)

Recruiting· Daiichi Sankyo logo

Daiichi Sankyo·Phase 3·NCT06731478·726 enrolled

Unresectable Breast Cancer2 trials

Real World Study of TrEatment Discontinuations and Modifications for Patients With HER2+ and HER2-low Metastatic Breast Cancer On Trastuzumab Deruxtecan

Completed· AstraZeneca logo

AstraZeneca··NCT06386263·22 enrolled

A Prospective, Non-interventional Study (NIS) With Trastuzumab Deruxtecan For Patients With HER2-(Ultra)Low Expressing Unresectable and/or Metastatic Breast Cancer Accompanied By a Disease Registry of Patients Treated With Conventional Chemotherapy (DESTINY Breast Respond HER2-(Ultra)Low Europe)

Recruiting· Daiichi Sankyo logo

Daiichi Sankyo··NCT05945732·2,295 enrolled

Desmoplastic Small Round Cell Tumor1 trial

A Phase 1/2 Study of DS-8201a (NSC# 807708) in Children, Adolescents, or Young Adults With Recurrent Osteosarcoma, Wilms Tumor, and Desmoplastic Small Round Cell Tumor

Recruiting·NNational Cancer Institute (NCI)·Preclinical·NCT04616560·55 enrolled

Anatomic Stage III Breast Cancer AJCC v81 trial

Phase 1b Study of Pidnarulex and Trastuzumab Deruxtecan in Patients With HER2 Expressing Solid Tumors

Recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT07137416·36 enrolled

Locally Advanced or Metastatic Non-small Cell Lung Cancer1 trial

An Open-label, Randomized, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Trastuzumab Deruxtecan as First-line Treatment of Unresectable, Locally Advanced, or Metastatic NSCLC Harboring HER2 Exon 19 or 20 Mutations (DESTINY-Lung04)

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT05048797·454 enrolled

18 more indications

Gastroesophageal Adenocarcinoma1 trial

A Master Protocol of an Open-Label, Multi-Drug, Multi-Center, Phase II Platform Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of Novel Agents or Combinations as Perioperative Treatment in Participants With Locally Advanced Resectable Gastroesophageal Adenocarcinoma (GEMINI-PeriOp GC)

Recruiting· AstraZeneca logo

AstraZeneca·Phase 2·NCT07069712·100 enrolled

Part 1: Bladder, Biliary Tract, Cervical, Endometrial, Ovarian, Pancreatic Cancer, Rare Tumors, Any Tumor Type Excluding Breast, Gastric, Colorectal Cancer1 trial

A Phase 2, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd, DS-8201a) for the Treatment of Selected HER2 Expressing Tumors (DESTINY-PanTumor02)

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 2·NCT04482309·477 enrolled

Breast Neoplasms1 trial

An Open-label, Randomized, Phase 3 Study to Evaluate Patritumab Deruxtecan Monotherapy Versus Treatment of Physician's Choice in Hormone Receptor-positive, HER2-negative Unresectable Locally Advanced or Metastatic Breast Cancer (HERTHENA-Breast04)

Recruiting· Merck & Co. logo

Merck & Co.·Phase 3·NCT07060807·1,000 enrolled

Recurrent or Metastatic Solid Tumors1 trial

A Phase 1, Multicenter Trial of Subcutaneous Trastuzumab Deruxtecan in Participants With Metastatic Solid Tumors

Recruiting· Daiichi Sankyo logo

Daiichi Sankyo·Phase 1·NCT07015697·76 enrolled

Metastatic Breast Cancer1 trial

Beamion BCGC-1: A Phase Ib Dose Escalation and Phase II Dose Optimization, Randomized, Open-label, Multicenter Trial of Oral Zongertinib (BI 1810631) Alone or in Combination With Other Agents for the Treatment of Patients With Advanced HER2+ Metastatic Breast Cancer (mBC), Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (mGEAC), or Metastatic Colorectal Cancer (mCRC)

Recruiting· Boehringer Ingelheim logo

Boehringer Ingelheim·Preclinical·NCT06324357·768 enrolled

Breast Cancer1 trial

Phase II Trial Evaluating Trastuzumab Deruxtecan and Lovastatin in HER2-low and Ultralow Advanced or Metastatic Breast Cancer (MBC)

Not yet recruiting·WWashington University School of Medicine·Phase 2·NCT07619365·60 enrolled

Biliary Tract Cancer1 trial

DESTINY-Biliary Tract Cancer-01: A Phase 3 Study of Trastuzumab Deruxtecan (T-DXd) and Rilvegostomig Versus Standard-of-Care Gemcitabine, Cisplatin, and Durvalumab for First Line Locally Advanced or Metastatic HER2-expressing Biliary Tract Cancer

Recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT06467357·620 enrolled

Advanced Solid Malignancies1 trial

A Modular Phase I/IIa, Open-label, Multi-centre Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of Ascending Doses of AZD9574 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Malignancies (CERTIS1)

Recruiting· AstraZeneca logo

AstraZeneca·Preclinical·NCT05417594·695 enrolled

Advanced Breast Cancer1 trial

A Global, Interventional, Open-label Trial of T-DXd-based Therapy Followed by Palbociclib, Endocrine Therapy and Dual HER2 Blockade in First-line HER2+/ HR+ Advanced or Metastatic Breast Cancer and Retreatment With T-DXd (DB-Guide)

Not yet recruiting· Daiichi Sankyo logo

Daiichi Sankyo·Phase 3·NCT07683754·200 enrolled

Non-Small Cell Lung Cancer1 trial

A Phase 3, Multicenter, Randomized, Open-label Trial of Trastuzumab Deruxtecan in Combination With Pembrolizumab Versus Platinum-based Chemotherapy in Combination With Pembrolizumab, as First-line Therapy in Participants With Locally Advanced Unresectable or Metastatic HER2 Overexpressing and PD-L1 TPS <50% Non-squamous Non-small Cell Lung Cancer (DESTINY-Lung06)

Recruiting· Daiichi Sankyo logo

Daiichi Sankyo·Phase 3·NCT06899126·686 enrolled

Ovarian Cancer1 trial

A Phase 3, Open-label, Multicenter, Randomized Trial of Trastuzumab Deruxtecan With Bevacizumab Versus Bevacizumab Monotherapy as First-line Maintenance Therapy in HER2-Expressing Ovarian Cancer (DESTINY-Ovarian01/ENGOT-ov89/GEICO144- O/GOG-3112/APGOT-OV13)

Recruiting· Daiichi Sankyo logo

Daiichi Sankyo·Phase 3·NCT06819007·582 enrolled

Stomach Neoplasms1 trial

A Phase II Platform Trial of Perioperative Therapies in Locally Advanced Unresectable Gastric Cancer (Neo-VIKTORY)

Recruiting·JJeeyun Lee·Phase 2·NCT06630130·100 enrolled

Anatomic Stage IV Breast Cancer AJCC v81 trial

Pilot Study to Evaluate 64Cu-DOTA-Trastuzumab Imaging in Patients With HER2+ Breast Cancer With Brain Metastatsis Treated With Fam-Trastuzumab Deruxtecan

Recruiting·CCity of Hope Medical Center·Approved·NCT05376878·10 enrolled

Adenocarcinoma (NOS)1 trial

Effectiveness of T-DXd Across HER2-positive Solid Tumors in Patients Who Have Received Prior Systemic Treatment and Have no Satisfactory Alternative Treatment Options: A Hybrid Observational Study

Recruiting· AstraZeneca logo

AstraZeneca··NCT07124000·100 enrolled

Breast Cancer Metastatic1 trial

Open-label Single-arm Phase 2 Trial of Trastuzumab Deruxtecan in Previously Treated HER2-Immunohistochemistry (IHC) 0 Advanced Breast Cancer

Recruiting·YYale University·Phase 2·NCT06750484·40 enrolled

Metastatic Salivary Gland Carcinoma1 trial

A Phase II Trial of HER2-Targeted Therapies for Recurrent, Metastatic, or Unresectable HER2-Expressing Salivary Gland Cancers

Recruiting·NNRG Oncology·Phase 2·NCT05408845·146 enrolled

Locally Advanced Lung Non-Small Cell Carcinoma1 trial

A Phase I/II Study Evaluating the Safety, Tolerability, and Efficacy of Sotorasib Plus Trastuzumab Deruxtecan in Patients With Advanced Non-Small Cell Lung Cancer With a KRASG12C Mutation

Recruiting·NNational Cancer Institute (NCI)·Preclinical·NCT07012031·37 enrolled

Endometrial Cancer1 trial

DESTINY-Endometrial01: An Open-Label, Sponsor-Blinded, Randomized, Controlled, Multicenter, Phase III Study of Trastuzumab Deruxtecan (T-DXd) Plus Rilvegostomig or Pembrolizumab vs Chemotherapy Plus Pembrolizumab as First-Line Therapy of HER2-Expressing (IHC 3+/2+), Mismatch Repair Proficient (pMMR), Primary Advanced or Recurrent Endometrial Cancer

Recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT06989112·600 enrolled

Sources

References

[1]
ClinicalTrials.gov — 25 trial records for Trastuzumab deruxtecan. U.S. National Library of Medicine, National Institutes of Health.
[2]
Open Targets Platform — Drug–disease associations for Trastuzumab deruxtecan. EMBL-EBI & Wellcome Sanger Institute.
[3]
SEC EDGAR — AstraZeneca company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Antibody–drug conjugate
Highest Phase: Approved[1]
Company: AstraZeneca

Trastuzumab deruxtecan

Status by Indication[2][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q2 2027

Q3 2027

Q4 2027

Trials by Indication[1]

Gastric Cancer2 trials

Unresectable Breast Cancer2 trials

Desmoplastic Small Round Cell Tumor1 trial

Anatomic Stage III Breast Cancer AJCC v81 trial

Locally Advanced or Metastatic Non-small Cell Lung Cancer1 trial

Gastroesophageal Adenocarcinoma1 trial

Part 1: Bladder, Biliary Tract, Cervical, Endometrial, Ovarian, Pancreatic Cancer, Rare Tumors, Any Tumor Type Excluding Breast, Gastric, Colorectal Cancer1 trial

Breast Neoplasms1 trial

Recurrent or Metastatic Solid Tumors1 trial

Metastatic Breast Cancer1 trial

Breast Cancer1 trial

Biliary Tract Cancer1 trial

Advanced Solid Malignancies1 trial

Advanced Breast Cancer1 trial

Non-Small Cell Lung Cancer1 trial

Ovarian Cancer1 trial

Stomach Neoplasms1 trial

Anatomic Stage IV Breast Cancer AJCC v81 trial

Adenocarcinoma (NOS)1 trial

Breast Cancer Metastatic1 trial

Metastatic Salivary Gland Carcinoma1 trial

Locally Advanced Lung Non-Small Cell Carcinoma1 trial

Endometrial Cancer1 trial

References

Drug Info

Quick Facts

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