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Esophagogastric AdenocarcinomaPhase 1/2NCT06123468

Study Evaluating Treatment of Sacituzumab-govitecan for Patients With Metastatic Esophagogastric Adenocarcinoma

A Phase 1/2 study testing Sacituzumab govitecan in people with Esophagogastric Adenocarcinoma, run by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest at 8 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The study is a open-label, single-arm, multicenter, phase Ib/II trial assessing the efficacy of sacituzumab-govitecan for metastatic esophagogastric adenocarcinoma 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?
Sacituzumab govitecan
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
8 sitesin 2 countries
Study dates
17 Apr 2024to 7 Jan 2026
Phase
Phase 1/2
Are there results?
None posted in the registry

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, in the investigator's judgement, willing and able to comply with the study protocol.
  • Patient is ≥ 18 years of age at time of signing the written informed consent.
  • Patient has been diagnosed with histologically confirmed metastatic (stage IV) esophagogastric adenocarcinoma.
  • Patient has received at least one prior therapy containing platinum compound and a fluoropyrimidine, potentially combined with immunotherapy, in the metastatic setting. Neoadjuvant/adjuvant platinum-fluoropyrimidine treatment is counted as first-line therapy if disease progression occurred within 6 months after completion of treatment.
  • NOTE: patients with advanced MSI-h/dMMR tumors who have not previously been treated with pembrolizumab, nivolumab or any other PD-1/PD-L1 inhibitor are not permitted for inclusion.
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  • Patient has an ECOG performance status ≤ 1.
  • Patient must have an estimated life expectancy of at least 12 weeks.
  • Patient has at least one measurable lesion on radiographic imaging as defined by RECIST v1.1.
  • Patient has adequate hematological, hepatic and renal function as indicated by the following parameters:
  • Leukocytes ≥ 2,500/μL, platelets ≥ 100,000/μL without transfusion, absolute neutrophil count (ANC) ≥ 1,500/μL without granulocyte colony-stimulating factor support, hemoglobin ≥ 90 g/L (9 g/dL) - Patients may be transfused to meet this criterion.
  • Bilirubin ≤ 1.5 x upper limit of normal (ULN), aspartate transaminase and alanine transaminase ≤ 2.5 x ULN (≤ 5 x ULN in case of liver metastases), alkaline phosphatase ≤ 2.5 x ULN (≤ 5 x ULN in case of liver metastases)
  • Serum creatinine ≤ 1.5 x ULN, or glomerular filtration rate > 45 mL/min (calculated per institutional standard)
  • Serum albumin ≥ 25 g/L (2.5 g/dL)
  • For patients not receiving therapeutic anticoagulation: INR or aPTT ≤ 1.5 x ULN; for patients receiving therapeutic anticoagulation: stable anticoagulant regimen
  • Patient must be willing to provide liquid biopsy samples for the translational research program.
  • Female patients of childbearing potential and male patients with female partners of childbearing potential 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 at least 6 months after the last study treatment. Male patients must refrain from donating sperm during this same period. Male patients with a pregnant partner must agree to

Who cannot join

  • Patient has known hypersensitivity to any component of the Sacituzumab-govitecan formulation as well as a known history of severe allergic, anaphylactic or other hypersensitivity reactions to chimeric or humanized antibodies or fusion protein.
  • Patient has received previously topoisomerase 1 inhibitors such as irinotecan, or nal-irinotecan
  • Patient has an active second malignancy. Note: patients with a history of malignancy that have been completely treated, with no evidence of active cancer for 3 years prior to enrollment, or patients with surgically cured tumors with low risk of recurrence (e.g., non-melanoma skin cancer, histologically confirmed complete excision of carcinoma in situ, or similar) are allowed to enroll
  • Patients with known, untreated and active (not stable within the last 4 weeks or symptomatic) brain metastases and patients with leptomeningeal disease.
  • Patient meets any of the following criteria for cardiac disease:
  • Myocardial infarction or unstable angina pectoris within 6 months prior to initiation of study treatment
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  • History of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation), high-grade atrioventricular bock, or other cardiac arrhythmias requiring antiarrhythmic medications (except for atrial fibrillation that is well controlled with antiarrhythmic medication); history of QT interval prolongation
  • New York Heart Associated (NYHA) class III or greater congestive heart failure or left ventricular ejection fraction (LVEF) of < 40% if echocardiography has been performed
  • Patient has an active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or gastrointestinal perforation within 6 months prior to initiation of study treatment
  • Patient has an active serious infection requiring antibiotic treatment
  • Patient has known history of human immune deficiency virus (HIV, or positive HIV antibody, if done at screening) with detectable viral load OR taking medications that may interfere with SN-38 metabolism
  • Patient has active hepatitis B or C virus (HBV/HCV). In patients with a history of HBV or HCV, patients with detectable viral loads will be excluded
  • Patient participated in another interventional clinical study ≤ 14 days prior to initiation of study treatment or at the same time as this study.
  • Patient has taken an investigational drug within 14 days or 5 half-lives (whichever is longer) prior to initiation of study treatment.
  • Patient received anticancer biologic agent within 28 days or targeted small molecule, radiation or chemotherapy within 14 days prior to initiation of the study treatment.
  • Patient has not recovered from AEs due to previously administered drug (i.e., ≥ grade 2 is concerned as not recovered)
  • Patients with any grade of alopecia are an exception to this criterion and will qualify for the study
  • If patients received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment
  • Patient has evidence of any other disease, neurologic or metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of any of the study medications, puts the patient at higher risk for treatment-related complications or may affect the interpretation of study results.
  • Female patients, who are pregnant or breast feeding or planning to become pregnant within and 6 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

8 sites in 2 countries.

8 sites in 2 countries

Germany7 sites

  • Hämatologisch-Onkologische Praxis Eppendorf

    Hamburg, 20249

  • Nationales Centrum für Tumorerkrankungen

    Heidelberg, 69120

  • Universitätsklinikum Jena

    Jena, 07747

  • Universitätsklinikum Leipzig

    Leipzig, 04103

  • Onkopraxis Probstheida

    Leipzig, 04289

  • Universitätsklinikum Mannheim

    Mannheim, 68167

  • Klinikum rechts der Isar der TU München

    München, 81675

Other trials in Germany

Austria1 site

  • SCRI-CCCIT GmbH

    Salzburg, 5020

Other trials in Austria

About this study

Official title: A Phase Ib/II Single-arm, Multicenter Study of Sacituzumab-govitecan, a TROP-2 Targeting Antibody Linked With SN38, for Patients With Metastatic Esophagogastric Adenocarcinoma

The study is a open-label, single-arm, multicenter, phase Ib/II trial assessing the efficacy of sacituzumab-govitecan for metastatic esophagogastric adenocarcinoma

Read the detailed description

All eligible enrolled patients will receive:Sacituzumab-govitecan 10 mg/kg i.v. at day 1 and day 8 of each 21-day cycle (Q3W). Patients will receive the treatment for a maximum of 12 months or until disease progression, unacceptable toxicity or withdrawal of consent, whichever occurs first.The primary objective of the trial is to evaluate the efficacy (primary endpoint: Overall Response Rate ORR, complete response + partial response) of sacituzumab-govitecan for metastatic esophagogastric adenocarcinoma. The secondary objectives are to further characterize the efficacy of sacituzumab-govitecan for metastatic esophagogastric adenocarcinoma and to evaluate safety and tolerability of sacituzumab-govitecan for metastatic esophagogastric adenocarcinoma. Secondary endpoints comprise the assessment of Clinical benefit rate (CBR, complete response + partial response + stable disease), Progression-free survival (PFS), Overall survival (OS), ORR, CBR, PFS and OS in the subgroup of TROP-2 overexpression, toxiticy. In addition, tissue and blood samples will be analyzed to evaluate the TROP-2 expression during treatment with sacituzumab-govitecan for metastatic esophagogastric adenocarcinoma.

56 patients will be enrolled in this trial.

Being tested
Sacituzumab govitecan
Keywords
gastric adenocarcinoma, GEJ adenocarcinoma

What participants receive

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

  • Sacituzumab govitecanDrug

    Also called Trodelvy

    10 mg/kg i.v. at day 1 and day 8 of each 21-day cycle (Q3W) for max 17 cycles (max. 12 months treatment)

Study groups in NCT06123468
Study groupRoleWhat they receive
Sacituzumab-govitecanExperimentalSingle arm with Sacituzumab-govitecan 10 mg/kg i.v. at day 1 and day 8 of each 21-day cycle (Q3W). Patients will receive the treatment for a maximum of 12 months.
Receives: Drug: Sacituzumab govitecan

What is being measured

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

  1. Overall response rate

    Objective response rate will be assessed according to RECIST v1.1. criteria and is defined as proportion of patients showing complete or partial response (CR+PR).

    Measured: up to 12 months

Secondary outcomes (4)

  1. Clinical benefit rate

    Clinical benefit rate will be assessed according to RECIST v1.1. criteria and is defined as proportion of patients showing complete response, partial response or stable disease (CR+PR+SD).

    Measured: up to 36 months

  2. Progression-free survival (PFS)

    Progression-free survival is defined as time from enrollment to the date of progression according to RECIST v1.1 or death due to any cause. Patients who have not experienced an event at the time of analysis will be censored at the most recent date of disease assessment.

    Measured: up to 36 months

  3. Overall survival (OS)

    Overall survival is defined as the time from enrollment to the date of death from any cause. Patients who have not experienced an event at the time of analysis will be censored at the date when the patient was last known to be alive.

    Measured: up to 36 months

  4. Safety and toxicity

    Safety and tolerability assessments will include physical examinations, clinical laboratory profile and continuous assessments of adverse events (AEs).

    AEs will be monitored throughout the trial and graded in severity according to the guidelines outlined in the NCI CTCAE v5.0.

    Measured: up to 13 months (max. 12 months treatment plus 30 days after last treatment)

Timeline

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

  1. First posted8 Nov 2023
  2. Study start17 Apr 2024
  3. Primary completion7 Jan 2026
  4. Study completion7 Jan 2026

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
Not applicable
Intervention model
Single group
Model description
All eligible enrolled patients will receive Sacituzumab-govitecan 10 mg/kg i.v. at day 1 and day 8 of each 21-day cycle (Q3W). Patients will receive the treatment for a maximum of 12 months or until disease progression, unacceptable toxicity or withdrawal of consent, whichever occurs first.
Masking
None (open label)
Enrolment
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06123468
Sponsor's protocol ID
SAGA
Other IDs
2023-505257-40-00, AIO-STO-0123/ass., IKF-t065, 2023
Status last verified
Jan 2026
First submitted
6 Nov 2023
Last updated
8 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No IPD will be shared.

Publications

  • Kobitzsch B, Stocker G, Hacker UT, Junge S, Pauligk C, Al-Batran SE, Goetze TO, Lordick F. SAGA-a phase Ib/II single-arm, multicenter study of sacituzumab govitecan for patients with metastatic esophagogastric adenocarcinoma. ESMO Gastrointest Oncol. 2024 Apr 12;4:100051. doi: 10.1016/j.esmogo.2024.100051. eCollection 2024 Jun.

    PubMed 41648033

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Sacituzumab govitecan in people with Esophagogastric Adenocarcinoma, run by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest at 8 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 17 inclusion and 20 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: finished, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Overall response rate (time frame: up to 12 months). 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 NCT06123468, which also lists 1 linked publication.

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 8 Jan 2026.

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