Trastuzumab deruxtecan clinical trials, in English

This is an umbrella study evaluating the how well it works and safety of multiple treatment combinations in participants with metastatic or inoperable locally advanced breast cancer. The study will be performed in two stages.

NCT03424005 · Official ClinicalTrials.gov record · Hoffmann-La Roche

This phase I/II trial studies the effects of trastuzumab deruxtecan (DS-8201a) in treating patients with osteosarcoma, Wilms tumor (WT) or desmoplastic small round cell tumor (DSRCT) that is newly diagnosed or has come back after a period of improvement (recurrent) or that has not responded to previous treatment (refractory). Trastuzumab deruxtecan is in a class of medications called antibody-drug conjugates.

NCT04616560 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)

This phase II trial compares the effect of usual treatment of docetaxel chemotherapy plus trastuzumab, to ado-emtansine (T-DM1) in patients with HER2-positive salivary gland cancer that has come back (recurrent), that has spread from where it first started (primary site) to other places in the body, or cannot be removed by surgery (unresectable). This trial is also testing how well trastuzumab deruxtecan works in treating patients with HER2-low recurrent or metastatic salivary gland cancer.

NCT05408845 · Official ClinicalTrials.gov record · NRG Oncology

The main purpose of this study is to learn more about the safety, side effects, and effectiveness of Vepugratinib by itself or when it is combined with other medicines that treat cancer. Vepugratinib may be used to treat cancer of the cells that line the urinary system and other solid tumor cancers that have a change in a particular gene (known as the FGFR3 gene).

NCT05614739 · Official ClinicalTrials.gov record · Eli Lilly and Company

This study will measure the safety and how well it works of DS-1103a combination therapy in participants with advanced solid tumors.

NCT05765851 · Official ClinicalTrials.gov record · Daiichi Sankyo

This study wants to test the safety and effectiveness of an investigational drug combination (trastuzumab deruxtecan and durvalumab) to learn whether the intervention works in treating Human Epidermal growth factor Receptor-2 (HER2)-expressing inflammatory breast cancer. The names of the study drugs involved in this study are: * Trastuzumab deruxtecan * Durvalumab

NCT05795101 · Official ClinicalTrials.gov record · Filipa Lynce, MD

This is a window-of-opportunity umbrella platform trial enrolling non-metastatic resectable colorectal patients selected for the presence of a specific targetable molecular alteration. The study aims to test the activity of specific targeted agents/combinations given as a short-course pre-operative strategy, matched with the specific alteration detected, followed by standard of care surgery.

NCT05845450 · Official ClinicalTrials.gov record · Gruppo Oncologico del Nord-Ovest

This open-label, multicenter, rollover study will provide continued treatment for participants deriving benefit from different therapies received in studies sponsored by Daiichi Sankyo, Inc. (DS) or DS/Astra Zeneca (AZ)-sponsored study.

NCT06174987 · Official ClinicalTrials.gov record · Daiichi Sankyo

This phase II ADC MATCH screening and multi-sub-study treatment trial is evaluating whether biomarker-directed treatment with one of three antibody-drug conjugates (ADCs) (sacituzumab govitecan, enfortumab vedotin, and trastuzumab deruxtecan) works in treating patients with solid tumor cancers that have high expression of the Trop-2, nectin-4, or HER2 proteins and that may have spread from where they first started (primary site) to nearby tissue, lymph nodes, or distant parts of the body (advanced) or to other places in the body (metastatic). Precision medicine is a form of medicine that uses information about a person's genes, proteins, and environment to prevent, diagnose, or treat disease in a way that is tailored to the patient.

NCT06311214 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)

This study is open to adults aged 18 years and older with different types of HER2+ cancer that has spread and cannot be removed by surgery. People can take part in this study if their tumours show HER2 aberrations and previous treatment was not successful.

NCT06324357 · Official ClinicalTrials.gov record · Boehringer Ingelheim

This phase I trial tests the safety, side effects, and best dose of azenosertib in combination with trastuzumab deruxtecan in treating patients with HER2-positive gastric or gastroesophageal junction cancer and other HER2-positive solid tumors that have spread to nearby tissue or lymph nodes (locally advanced), that have spread from where it first started (primary site) to other places in the body (metastatic), or that cannot be removed by surgery (unresectable). Azenosertib is in a class of medications called kinase inhibitors.

NCT06364410 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)

This study wants to measure the how well it works and safety of T-DXd with rilvegostomig or T-DXd this drug alone compared with gemcitabine plus cisplatin and durvalumab in patients with advanced treatment naïve HER2-expressing BTC.

NCT06467357 · Official ClinicalTrials.gov record · AstraZeneca

This trial studies a type of advanced breast cancer defined as hormone receptor HR-positive/HER2-negative and classified as non-luminal by gene expression profiling (PAM50). Patients will be treated with trastuzumab deruxtecan (T-DXd) or with physician's choice of CDK4/6 inhibitor (CDK4/6i) plus endocrine therapy (ET).

NCT06486883 · Official ClinicalTrials.gov record · MedSIR

This trial investigates a new drug, EIS-12656, in participants with specified advanced solid tumors carrying pre-specified mutations. The trial consists of a dose escalation part (Phase 1) and a dose expansion part (Phase 2).

NCT06525298 · Official ClinicalTrials.gov record · Eisbach Bio GmbH

After an initial screening phase to identify patients with persistent blood circulating DNA tumors, patients will be enrolled in the treatment phase that was designed as an open-label, multicentre, phase II study, to test the how well it works of trastuzumab deruxtecan in terms of progression-free survival (PFS).

NCT06680596 · Official ClinicalTrials.gov record · UNICANCER

This is a Phase Ⅲ, randomly assigned, open-label, Sponsor-blinded, 3-arm, global, multicenter study assessing the how well it works and safety of rilvegostomig in combination with fluoropyrimidine and T-DXd (Arm A) compared to trastuzumab, chemotherapy, and pembrolizumab (Arm B) in HER2-positive locally advanced or metastatic gastric or GEJ adenocarcinoma participants whose tumors express PD L1 CPS ≥ 1. Rilvegostomig in combination with trastuzumab and chemotherapy will be evaluated in a separate arm (Arm C) to assess the contribution of each component in the experimental arm.

NCT06764875 · Official ClinicalTrials.gov record · AstraZeneca

This clinical trial is designed to measure the how well it works and safety of T-DXd in combination with bevacizumab versus bevacizumab this drug alone as first-line maintenance therapy, in participants with human epidermal growth factor 2 (HER2)-expressing (immunohistochemistry \[IHC\] 3+/2+/1+) advanced high-grade epithelial ovarian cancer.

NCT06819007 · Official ClinicalTrials.gov record · Daiichi Sankyo

This clinical trial is designed to assess the how well it works and safety of trastuzumab deruxtecan (T-DXd; Enhertu®) in combination with pembrolizumab versus platinum-based chemotherapy in combination with pembrolizumab in participants with no prior therapy for locally advanced unresectable or metastatic non-squamous NSCLC, whose tumors have HER2-overexpressing and PD-L1 TPS \<50% without known AGA that have locally available therapies targeting their AGAs in first-line advanced/metastatic setting.

NCT06899126 · Official ClinicalTrials.gov record · Daiichi Sankyo

DESTINY-Endometrial01 will investigate the how well it works of first-line T-DXd + rilvegostomig (Arm A) and/or T-DXd+ pembrolizumab (Arm B) when compared to chemotherapy (carboplatin + paclitaxel) + pembrolizumab (Arm C), by assessment of progression free survival (PFS), as assessed by BICR, in participants with HER2-expressing (IHC 3+/2+), pMMR, primary advanced (Stage III/IV) or recurrent EC.

NCT06989112 · Official ClinicalTrials.gov record · AstraZeneca

The Substudy Protocol ASPEN-09-03 is a Phase 2, single-arm, multicenter study evaluating the how well it works, safety, and tolerability of evorpacept in combination with trastuzumab and chemotherapy in participants with HER2-positive metastatic breast cancer who have previously received trastuzumab-deruxtecan. ASPEN-09-03 is a substudy under Master Protocol ASPEN-09, and additional substudies are as follows: * Metastatic colorectal cancer (CRC) - dose escalation phase to evaluate evorpacept in combination with other drugs.

NCT07007559 · Official ClinicalTrials.gov record · ALX Oncology Inc.

This phase I/II trial tests the safety, side effects and best dose of sotorasib with trastuzumab deruxtecan and how well the combination works in treating patients with KRAS G12C mutated non-small cell lung cancer that has spread to nearby tissues or lymph nodes (locally advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). Sotorasib blocks a protein made by the mutated KRAS gene (KRAS p.G12C), which may help keep tumor cells from growing and may kill them.

NCT07012031 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)

This study is designed to assess how well it works and safety of T-DXd adjuvant therapy, with or without radiotherapy, post-surgery in anticancer treatment naïve (including neoadjuvant therapy) endometrial cancer with various HER2 expression levels.

NCT07022483 · Official ClinicalTrials.gov record · Daiichi Sankyo

Researchers are looking for other ways to treat breast cancer (BC) that is hormone receptor-positive and human epidermal growth factor receptor 2-negative (HR+/HER2-) and either unresectable locally advanced or metastatic. * HR positive (HR+) means the cancer cells have proteins that attach to estrogen or progesterone (hormones) which help the cancer to grow and spread * HER2 negative (HER2-) means the cancer cells have a low amount of a protein called HER2 * Unresectable locally advanced means the cancer cannot be completely removed by surgery and has spread into nearby tissue or muscles * Metastatic means the cancer has spread to other parts of the body Treatment for this type of breast cancer usually includes endocrine therapy (ET) and sometimes a second treatment.

NCT07060807 · Official ClinicalTrials.gov record · Merck Sharp & Dohme LLC

GEMINI-PeriOp GC study will assess the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity of novel agents or novel combinations as perioperative treatment in participants with locally advanced resectable gastric, gastroesophageal junction (GEJ), or esophageal adenocarcinoma who have not received previous treatment for the disease.

NCT07069712 · Official ClinicalTrials.gov record · AstraZeneca

This is a study that will enroll patients with cancer who have tumors that may have spread. The patients will know what medication they are being given.

NCT07086768 · Official ClinicalTrials.gov record · Lei Zheng

Multiple trials confirm systemic T-DXd how well it works in HER2+ breast cancer with leptomeningeal/brain metastases, yet median LM survival remains 3-4 months, highlighting unmet needs. While systemic therapies improve survival, intracranial disease control remains limited due to poor BBB penetration.

NCT07134153 · Official ClinicalTrials.gov record · Fudan University

This phase I trial tests the safety, side effects, and best dose of pidnarulex in combination with trastuzumab deruxtecan in treating patients with breast cancer and other solid tumors that express varying levels of a protein called HER2 and that has spread from where it first started (primary site) to other places in the body (metastatic), that cannot be removed by surgery (unresectable), or that has spread to nearby tissue or lymph nodes (locally advanced). Pidnarulex is an enzyme inhibitor that causes cell death and prevents tumor cell growth.

NCT07137416 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)

This is a multicenter, prospective, non-randomly assigned, open-label, pharmacokinetic study, aiming to compare the plasma exposure of the payload (free-DXd) in patients treated by T-DXd for locally advanced or metastatic breast cancer according to their body-mass index (BMI). The primary objective is to compare plasma exposition of the payload (free-DXd) between overweight or obese (body-mass index (BMI)\>25) and normal weight (body-mass index (BMI)≤25) breast cancer patients during the first 3 cycles of Trastuzumab-Deruxtecan (T-DXd).

NCT07195344 · Official ClinicalTrials.gov record · Institut Claudius Regaud

To find out if certain drug/therapy combinations that are targeted to individual patients based on characteristics of their disease types may help to control the disease.

NCT07318389 · Official ClinicalTrials.gov record · M.D. Anderson Cancer Center

This phase III trial evaluates the effect of adding locoregional therapy (surgery and radiation) and metastasis-directed stereotactic body radiation therapy (SBRT) to standard systemic therapy following standard HER2-targeted systemic therapy, compared to standard systemic therapy alone, in treating patients with HER2-positive stage IV breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic) or to a limited number of sites (oligometastatic). The usual approach for patients with (oligo)metastatic HER2-positive breast cancer is systemic drug treatment, which means medicines that travel through the whole body to treat both the breast and any areas where the cancer has spread.

NCT07578116 · Official ClinicalTrials.gov record · SWOG Cancer Research Network

This phase I/II trial tests the safety, side effects, best dose and how well giving selumetinib with trastuzumab deruxtecan (DS-8201a) works for the treatment of pancreatic ductal adenocarcinoma that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced), that cannot be removed by surgery (unresectable) or that has spread from where it first started (primary site) to other places in the body (metastatic). Selumetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

NCT07619521 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)

This study will evaluate a structured sequential treatment strategy starting with T-DXd + pertuzumab upfront therapy, followed by an optimized maintenance therapy with dual HER2+blockade + CDK4/6i + ET and the opportunity to retreat with T-DXd once patients progress under maintenance aimed to maximizing disease control, optimizing tolerability, and preserving T-DXd as a future therapeutic option, while ensuring participant safety and regulatory compliance in participants with HER2+/HR+ advanced/metastatic breast cancer.

NCT07683754 · Official ClinicalTrials.gov record · Daiichi Sankyo

The goal of this clinical trial is to learn if single-agent SMP-656 works to treat patients with HER2-positive locally advanced or metastatic breast cancer who have progressed after prior HER2-targeted topoisomerase inhibitor antibody-drug conjugate (ADC) treatment. It will also measure the safety of SMP-656 and identify the optimal dose for future trials.

NCT07726342 · Official ClinicalTrials.gov record · Chengdu SciMount Pharmatech Co., Ltd.