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Esophagogastric AdenocarcinomaPhase 1/2NeoARTNCT06731803

Platform Trial Evaluating Treatment of Neoadjuvant Trastuzumab-deruxtecan Containing Combination Therapies for HER2+, Resectable Esophagogastric Adenocarcinoma

A Phase 1/2 study testing Trastuzumab deruxtecan + 5FU/LV and Trastuzumab deruxtecan + FLO in people with Esophagogastric Adenocarcinoma, run by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest at 14 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The study is a phase Ib/II, prospective, single arm, open label, non-randomized, multi-center platform trial assessing the feasibility and safety of different neoadjuvant trastuzumab-deruxtecan containing combinational treatment regimens in patients with HER2 positive, locally advanced, resectable esophagogastric… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Esophagogastric Adenocarcinoma
What is being tested?
Trastuzumab deruxtecan + 5FU/LV and Trastuzumab deruxtecan + FLO
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
14 sitesin 2 countries
Study dates
25 Mar 2025to 31 Dec 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient* has given written informed consent.
  • Patient is ≥ 18 years of age at time of signing the written informed consent.
  • Patient has histologically proven locally advanced (cT2-4, any cN, M0 OR any cT, cN+, M0 stage) gastric, esophagogastric junction or lower esophageal adenocarcinoma that:
  • Is considered technically resectable
  • Does not involve distant site of the peritoneal cavity
  • confirmed by diagnostic laparoscopy for all patients with tumors located in the stomach and those with type 2 and 3 GEJ adenocarcinomas according to guideline recommendation [Lordick et al. 2022].
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  • Type 1 GEJ and lower esophageal tumors can be enrolled without diagnostic laparoscopy (which is in line with guidelines and the current routine practice in Germany)
  • Patient has a HER2 positive tumor (by local testing) defined by HER2 IHC 3+ or IHC 2+ plus ISH positive with a HER2:CEP17 ratio of ≥ 2 according to classically used criteria for defining HER2 positivity [Lordick et al. 2017] .
  • Patient has a ECOG performance status 0 or 1.
  • Patient has adequate blood count, liver-enzymes, and renal function:
  • ANC > 1,500 cells/μL without the use of hematopoietic growth factors
  • Platelet count ≥ 100 x 109/L (>100,000 per mm3)**
  • Hemoglobin ≥ 9 g/dL**
  • Serum total bilirubin ≤ 1.5x institutional upper normal limit (ULN)
  • AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional ULN
  • Patients not receiving therapeutic anticoagulation must have an INR ≤ 1.5 ULN and aPTT ≤ 1.5 ULN. The use of full dose anticoagulants is allowed as long as the INR or PTT is within therapeutic limits (according to the medical standard in the institution) and the patient has been on a stable dose for anticoagulants for at least three weeks at the time of inclusion
  • Serum Creatinine ≤ 1.5 x ULN and a calculated creatinine clearance rate ≥ 50 mL /min
  • Female patients defined as women of childbearing potential (WOCBP) must agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of <1% per year during the treatment period and for 6 months after last dose of chemotherapy or 7 months after the last dose of T-DXd, whatever is later.
  • Male patients with WOCBP partners must agree to remain abstinent (refrain from heterosexual intercourse) or use barrier contraceptive during the treatment period as well as up to 4 months after last dose of T-DXd or up to 6 months after last dose of chemotherapy, whatever is later. Male patients must refrain from donating sperm during this same period.

Who cannot join

  • Patient received previous (radio)chemotherapy or HER2-targeted therapy for the same condition or within the past five years for any other cancerous condition.
  • Patient received prior partial or complete esophagogastric tumor resection.
  • Patient has known hypersensitivity to any component of the T-DXd formulation as well as a known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion protein and/or any known contraindication (including hypersensitivity) to one of the study drugs.
  • Patient has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
  • Patient has lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (e.g., pulmonary emboli within three months of the study enrolment, severe asthma, severe COPD, restrictive lung disease, pleural effusion etc.).
  • Patient received a prior complete pneumonectomy
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  • Patient has inadequate cardiac function (LVEF value < 50 %) as determined by echocardiography.
  • Patient has a known complete absence of dihydropyrimidine dehydrogenase (DPD) activity
  • Patient received treatment with brivudine, sorivudine or their chemically related analogues within 28 days prior to stud enrollment
  • Patients has pernicious anemia or other megaloblastic anemia due to vitamin B12 deficiency
  • Patient has peripheral sensitive neuropathy with functional deficits.
  • Patient has a medical history of myocardial infarction (MI) within 6 months before enrollment, symptomatic congestive heart failure (CHF) (New York Heart Association Class II to IV). Subjects with troponin levels above ULN at screening (as defined by the manufacturer), and without any MI related symptoms should have a cardiologic consultation during screening to rule out MI.
  • Patient has a corrected QT interval (QTc) prolongation to > 470 ms (females) or >450 ms (males) based on average of the screening triplicate12-lead ECG.
  • Patient has a history of malignancy other than EGA except for:
  • Malignancy treated with curative intent and with no known active disease ≥ 5 years before the first dose of study treatment and of low potential risk for recurrence.
  • Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
  • Adequately treated carcinoma in situ without evidence of disease.
  • Patient has an uncontrolled infection requiring IV antibiotics, antivirals or antifungals
  • Patient has active primary immunodeficiency, known uncontrolled active HIV infection or active hepatitis B or C (HBV/HCV) infection. Patients positive for HCV antibody are eligible only if PCR is negative for HCV RNA. Subjects with past or resolved HBV infection are eligible only if they meet all of the following criteria*:
  • HBsAg(-) (for > 6 months off anti-viral treatment)
  • Anti-HBc(+) (IgG or total Ig)
  • HBV DNA undetectable
  • Absence of cirrhosis or fibrosis on prior imaging or biopsy
  • Absence of HCV co-infection or history of HCV co-infection
  • Access to a local hepatitis B expert during and after the study
  • Patient has any autoimmune, connective tissue or inflammatory disorders (e.g., Rheumatoid arthritis, Sjogren's, sarcoidosis etc.) with a documented or suspected pulmonary involvement
  • Patient received live, attenuated vaccine within 30 days prior initiation of study drug
  • Patient has any other serious concomitant or medical condition that, in the opinion of the investigator, presents a high risk of complications to the patient or reduces the likelihood of clinical effect.
  • Patient participated in another interventional clinical study within 28 days prior to study enrollment or participation in a clinical study at the same time as this study, unless it is an observational/ non-interventional study or during the follow-up period of an interventional study.
  • Patient has taken an investigational drug within 28 days prior to initiation of study drug.
  • Female patients, who are pregnant or breast feeding or planning to become pregnant within 7 months after the end of treatment. Female patients of childbearing potential must have a negative serum pregnancy test result within 7 days prior to initiation of study treatment

Trial locations and contacts

14 sites in 2 countries.

14 sites in 2 countries

Germany12 sites

  • Charite Universitätsmedizin Berlin

    Berlin, 13353

  • Klinikum Chemnitz gGmbH

    Chemnitz, 09116

  • KEM | Kliniken Essen Mitte gGmbH Klinik für Internistische Onkologie / Hämatologie mit Integrierter Palliativmedizin

    Essen, 45136

  • Krankenhaus Nordwest GmbH Institut für Klinisch-Onkologische Forschung (IKF)

    Frankfurt am Main, 60488

  • Universitätsmedizin Halle, Universitätsklinikum Halle (Saale)

    Halle, 06120

  • Hämatologisch-Onkologische Praxis Eppendorf (hope)

    Hamburg, 20249

  • Nationales Centrum für Tumorerkrankungen

    Heidelberg, 69120

  • Universitätsklinikum Jena

    Jena, 07747

  • Universitätsklinikum Leipzig

    Leipzig, 04103

  • Klinikum rechts der Isar München der TU München

    München, 81675

  • Klinikum Nürnberg

    Nuremberg, 90419

  • Universitätsklinikum Ulm

    Ulm, 89081

Other trials in Germany

Austria2 sites

  • Uniklinikum Salzburg, Universitätsinstitut für Innere Medizin III der PMU

    Salzburg, 5020

  • Medizinische Universität Wien, Universitätsklinik für Innere Medizin I

    Vienna, 1090

Other trials in Austria

About this study

Official title: NeoART - A Phase Ib/II Platform Trial Evaluating the Safety and Activity of Neoadjuvant Trastuzumab-deruxtecan Containing Combination Therapies for HER2+, Resectable Esophagogastric Adenocarcinoma

The study is a phase Ib/II, prospective, single arm, open label, non-randomized, multi-center platform trial assessing the feasibility and safety of different neoadjuvant trastuzumab-deruxtecan containing combinational treatment regimens in patients with HER2 positive, locally advanced, resectable esophagogastric adenocarcinoma

Read the detailed description

The NeoART trial consists of cohorts focusing on distinct trastuzumab-deruxtecan (T-DXd) combination therapies. Enrolment of patients in the two currently defined cohorts will be consecutive, i.e., recruitment for NeoART-002 will start after full recruitment of NeoART-001.

All eligible patients in NeoART-001 cohort will receive: Trastuzumab-deruxtecan 5.4 mg/kg i.v., on day 1, Q3W plus 5-FU/LV: leucovorin 200 mg/m2 i.v., followed by 5-fluorouracil (5-FU) 2600 mg/m2 as a 24-h continuous infusion on day 1, Q2W. Patients will receive three cycles of neoadjuvant T-DXd combined with four cycles 5-FU/LV followed by surgery. Surgery will be scheduled 3-4 weeks after completion of the last cycle of preoperative study therapy.

All eligible patients in NeoART-002 cohort will receive: Trastuzumab-deruxtecan 5.4 mg/kg i.v., on day 1, Q3W plus FLO:oxaliplatin 85 mg/m2 \& leucovorin 200 mg/m2, each as an i.v. infusion followed by 5-FU 2600 mg/ m2 as a 24-h continuous infusion on day 1, Q2W. Patients will receive three cycles of neoadjuvant trastuzumab-deruxtecan combined with four cycles FLO followed by surgery.

Surgery will be scheduled 3-4 weeks after completion of the last cycle of preoperative study therapy.

The primary objective of the trial is to evaluate the feasibility and safety (primary endpoint: feasibility rate) of different neoadjuvant T-DXd containing combinational treatment regimens in patients with HER2 positive, locally advanced, resectable esophagogastric adenocarcinoma. The secondary objectives are to futher characterize the efficacy of different neoadjuvant trastuzumab-deruxtecan containing combinational treatment regimens and to evaluate safety and tolerability of different neoadjuvant T-DXd containing combinational treatment regimens. Secondary endpoints comprise the assessment of toxiticy, Perioperative morbidity, Pathological complete remission and R0 resection rate.

Up to 18 patients will be enrolled into each cohort.

Being tested
Trastuzumab deruxtecan + 5FU/LV, Trastuzumab deruxtecan + FLO
Keywords
gastric adenocarcinoma, GEJ adenocarcinoma, Her2 positive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Trastuzumab deruxtecan + 5FU/LVDrug

    trastuzumab deruxtecan 5.4 mg/kg i.v., on day 1, Q3W for max 3 cycles plus 4 cycles 5-FU/LV: leucovorin 200 mg/m2 i.v., followed by 5-fluorouracil (5-FU) 2600 mg/m2 as a 24-h continuous infusion on day 1, Q2W for 4 cycles

  • Trastuzumab deruxtecan + FLODrug

    trastuzumab deruxtecan 5.4 mg/kg i.v., on day 1, Q3W for max 3 cycles plus 4 cycles FLO: oxaliplatin 85 mg/m2 and leucovorin 200 mg/m2, each as an i.v. infusion followed by 5-FU 2600 mg/ m2 as a 24-h continuous infusion on day 1, Q2W for 4 cycles

Study groups in NCT06731803
Study groupRoleWhat they receive
NeoART-001ExperimentalTrastuzumab-deruxtecan 5.4 mg/kg i.v., on day 1, Q3W plus 5-FU/LV: leucovorin 200 mg/m2 i.v., followed by 5-fluorouracil (5-FU) 2600 mg/m2 as a 24-h continuous infusion on day 1, Q2W. Patients will receive three cycles of neoadjuvant T-DXd combined with four cycles 5-FU/LV followed by surgery.
Receives: Drug: Trastuzumab deruxtecan + 5FU/LV
NeoART-002ExperimentalTrastuzumab-deruxtecan 5.4 mg/kg i.v., on day 1, Q3W plus FLO: oxaliplatin 85 mg/m2 \& leucovorin 200 mg/m2, each as an i.v. infusion followed by 5-FU 2600 mg/ m2 as a 24-h continuous infusion on day 1, Q2W. Patients will receive three cycles of neoadjuvant T-DXd combined with four cycles 5-FU/LV followed by surgery.
Receives: Drug: Trastuzumab deruxtecan + FLO

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility rate

    Feasibility rate, defined as proportion of patients receiving the protocol treatment according to the planned schedule before surgery without occurrence of at least one dose-limiting toxicity (DLT)

    Measured: 9 weeks

Secondary outcomes (2)

  1. Safety and toxicity

    Assessment of safety of the treatment as determined by the incidence, type, causality, frequency, timing and severity of adverse events using NCI CTCAE 5.0 and perioperative morbidity (Clavien-Dindo classification) and mortality

    Measured: up to 7.5 months

  2. Pathological complete remission

    Efficacy will be assessed by the Pathological complete remission (pCR) rate by local assessment corresponding to the ypT0 ypN0 stage category and R0 resection rate

    Measured: up to 10 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Dec 2024
  2. Study start25 Mar 2025
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
All eligible patients in cohort NeoART-001 will receive: Trastuzumab-deruxtecan 5.4 mg/kg i.v., on day 1, Q3W plus 5-FU/LV: leucovorin 200 mg/m2 i.v., followed by 5-fluorouracil (5-FU) 2600 mg/m2 as a 24-h continuous infusion on day 1, Q2W All eligible patients in cohort NeoART-002 will receive: Trastuzumab-deruxtecan 5.4 mg/kg i.v., on day 1, Q3W plus FLO: oxaliplatin 85 mg/m2 \& leucovorin 200 mg/m2, each as an i.v. infusion followed by 5-FU 2600 mg/ m2 as a 24-h continuous infusion on day 1, Q2W followed by surgery determined by the location of the primary tumor and post-operative care according to the guidelines and to local standards outside of this trial.
Masking
None (open label)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06731803
Sponsor's protocol ID
NeoART
Other IDs
2024-518841-12-00, AIO-STO-0124, IKF072
Acronym
NeoART
Status last verified
Mar 2026
First submitted
9 Dec 2024
Last updated
21 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Trastuzumab deruxtecan + 5FU/LV and Trastuzumab deruxtecan + FLO in people with Esophagogastric Adenocarcinoma, run by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest at 14 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Germany, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility rate (time frame: 9 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06731803.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.

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