Neoplasms

All Conditions

Digestive System Diseases

Rare Diseases

Carcinoma

Adenocarcinoma

Stomach Neoplasms

Esophageal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Esophageal Cancer

Antineoplastic Agents

All Drugs and Chemicals

Capecitabine

Trastuzumab

Pembrolizumab

Trastuzumab deruxtecan

Fluorouracil

Cisplatin

Durvalumab

Oxaliplatin

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Immunoconjugates

Trastuzumab, 5-FU or capecitabine, and cisplatin or oxaliplatin

T-DXd, pembrolizumab and 5-FU or capecitabine

T-DXd, Volrustomig and 5-FU or capecitabine

T-DXd, Rilvegostomig and 5-FU or capecitabine

Fluorouracil (5-FU)

Durvalumab: administered as an IV infusion

Oxaliplatin: administered as an IV infusion

Trastuzumab: administered as an IV infusion

Cisplatin: administered as an IV infusion

Pembrolizumab: administered as an IV infusion

Volrustomig: administered as an IV infusion

Volrustomig

Rilvegostomig: administered as an IV infusion

Rilvegostomig

AstraZeneca Clinical Study Information Center

DESTINY-Gastric03 will investigate the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of trastuzumab deruxtecan (T-DXd) alone or in combination with chemotherapy and/or immunotherapy in HER2-expressing advanced/metastatic gastric/gastroesophageal junction (GEJ) and esophageal adenocarcinoma patients.

Study hypotheses: Combination of T-DXd with cytotoxic chemotherapy and/or immunotherapy administered to subjects at the recommended phase 2 dose will show manageable safety and tolerability and preliminary anti-tumor efficacy so as to permit further clinical testing. T-DXd in combination with cytotoxic chemotherapy or immune checkpoint inhibitor administered to HER2-expressing gastric, GEJ and esophageal cancer patients who have not received prior treatment for advanced/metastatic disease will show preliminary evidence of anti-tumour activity and the potential to become a therapeutic option for this patient population.

The study will consist of 2 phases: a dose escalation phase (Part 1) and dose expansion phases (Part 2, Part 3 and Part 4). Part 1 will enroll HER2-overexpressing (IHC 3+ or IHC 2+/ISH+), previously treated gastric, gastro-esophageal junction (GEJ) or esophageal cancer patients, and Part 2 will enroll HER2-overexpressing patients who have not received prior treatment for metastatic or unresectable disease. Part 3 and Part 4 will enroll HER2-expressing patients who have not received prior treatment for metastatic or unresectable disease.

In addition to safety and tolerability, this study will also assess ORR, DoR, DCR, OS, PFS and other measures of antitumor activity among treatment groups. Tumor evaluation using RECIST v1.1 will be conducted at screening and every 6 weeks until RECIST 1.1 objective disease progression or withdrawal of consent.

Ph1b/2 Study of the Safety and Efficacy of T-DXd Combinations in Advanced HER2-expressing Gastric Cancer (DESTINY-Gastric03)

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)

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Occurrence of AEs and SAEs graded according to NCI CTCAE v5.0

Changes in laboratory parameters (every in appropriate units) compared to baseline results.

Changes in vital signs results compared to baseline results.

Changes in ECG results compared to baseline results.

Confirmed ORR per RECIST 1.1 is the percentage of patients with Complete Response or Partial Response that is subsequently confirmed.

Changes in body weight in kilograms compared to baseline results.

DOR is defined as the time from the date of first documented response until the date of documented progression or death

DCR is the percentage of subjects who have a best overall response of complete response (CR) or partial response (PR) or stable disease (SD)

PFS is the time from date of first dose until the date of objective disease progression or death

OS is the time from date of first dose until death due to any cause

Individual participant data and descriptive statistics will be provided for serum concentration data at each time point for each dose level for T-DXd, total anti-HER2 antibody, MAAA-1181a

Individual participant data and descriptive statistics will be provided for serum concentration data at each time point for durvalumab.

Individual participant data and descriptive statistics will be provided for data at each time point for each dose level for T-DXd and durvalumab.

Individual participant data and descriptive statistics will be provided for data at each time point for rilvegostomig and volrustomig

Comparison of objective response rate between participants using local HER2 test results and central HER2 test results from tumor samples with evaluable results

Comparison of disease control rate between participants using local HER2 test results and central HER2 test results from tumor samples with evaluable results

Comparison of duration of response between participants using local HER2 test results and central HER2 test results from tumor samples with evaluable results

Comparison of progression-free survival between participants using local HER2 test results and central HER2 test results from tumor samples with evaluable results

Comparison of overall survival between participants using local HER2 test results and central HER2 test results from tumor samples with evaluable results

Daiichi Sankyo Company, Limited 3-5-1 Nihonbashihoncho, Chuo-ku, Tokyo

AstraZeneca

Respiratory Tract (Lung and Bronchial) Diseases

Symptoms and General Pathology

Carcinoma, Non-Small-Cell Lung

Emergencies

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

6 mg/kg intravenous infusion Q3W (on Day 1 of each 21-day cycle)

Datopotamab deruxtecan

Contact for Program Information

Principal Investigator

Global Medical Affairs

The purpose of this Medical Access Program (also referred to as an Expanded Access Program in the USA) is to provide access to Dato-DXd for eligible patients with previously treated advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) who, in their treating physician's opinion, have an unmet clinical need, are unlikely to obtain optimal benefit from currently approved and commercially available drugs, and who cannot enter a suitable clinical trial.

This is a Medical Access Program that will be available to adult patients in the USA with previously treated advanced or metastatic nonsquamous NSCLC who have no suitable treatment options and are not able to enter a clinical trial.

Patients enrolled in the Medical Access Program can continue treatment until any of the following occurs:

* Disease progression
* Unacceptable toxicity
* The benefit-risk no longer favors the individual
* Dato-DXd becomes commercially available and reimbursement is approved
* The patient chooses to discontinue treatment
* Withdrawal of consent
* Pregnancy
* Physician discretion
* Death

Patients enrolled in the Medical Access Program have an option to participate in collection of safety-focused clinical practice data. This will contribute towards better understanding of the clinical experience of treatment with Dato-DXd. Participation in this optional data collection will have no bearing on receipt of treatment.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Ph1b/2 Study of the Safety and Efficacy of T-DXd Combinations in Advanced HER2-expressing Gastric Cancer (DESTINY-Gastric03)	NCT04379596	Gastric Cancer	Fluorouracil (5... Capecitabine Durvalumab Oxaliplatin Trastuzumab Trastuzumab der... Cisplatin Pembrolizumab Volrustomig Rilvegostomig	18 Years - 130 Years	AstraZeneca
Medical Access Program for Datopotamab Deruxtecan in NSCLC Patients	NCT06279728	Advanced Non-Sm... Metastatic Non ...	Datopotamab der...	18 Years -	Daiichi Sankyo
Ph1b/2 Study of the Safety and Efficacy of T-DXd Combinations in Advanced HER2-expressing Gastric Cancer (DESTINY-Gastric03)	NCT04379596	Gastric Cancer	Fluorouracil (5... Capecitabine Durvalumab Oxaliplatin Trastuzumab Trastuzumab der... Cisplatin Pembrolizumab Volrustomig Rilvegostomig	18 Years - 130 Years	AstraZeneca

Spots Global Cancer Trial Database for deruxtecan

Every month we try and update this database with for deruxtecan cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for deruxtecan

Every month we try and update this database with for deruxtecan cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for deruxtecan cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.