Trial Title:
Study Evaluating Treatment of Sacituzumab-govitecan for Patients With Metastatic Esophagogastric Adenocarcinoma
NCT ID:
NCT06123468
Condition:
Esophagogastric Adenocarcinoma
Conditions: Official terms:
Adenocarcinoma
Sacituzumab govitecan
Conditions: Keywords:
gastric adenocarcinoma
GEJ adenocarcinoma
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention 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.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Sacituzumab govitecan
Description:
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)
Arm group label:
Sacituzumab-govitecan
Other name:
Trodelvy
Summary:
The study is a open-label, single-arm, multicenter, phase Ib/II trial assessing the
efficacy of sacituzumab-govitecan for metastatic esophagogastric adenocarcinoma
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Patient* has given written informed consent.
2. Patient is, in the investigator's judgement, willing and able to comply with the
study protocol.
3. Patient is ≥ 18 years of age at time of signing the written informed consent.
4. Patient has been diagnosed with histologically confirmed metastatic (stage IV)
esophagogastric adenocarcinoma.
5. 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.
6. Patient has an ECOG performance status ≤ 1.
7. Patient must have an estimated life expectancy of at least 12 weeks.
8. Patient has at least one measurable lesion on radiographic imaging as defined by
RECIST v1.1.
9. Patient has adequate hematological, hepatic and renal function as indicated by the
following parameters:
1. 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.
2. 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)
3. Serum creatinine ≤ 1.5 x ULN, or glomerular filtration rate > 45 mL/min
(calculated per institutional standard)
4. Serum albumin ≥ 25 g/L (2.5 g/dL)
5. For patients not receiving therapeutic anticoagulation: INR or aPTT ≤ 1.5 x
ULN; for patients receiving therapeutic anticoagulation: stable anticoagulant
regimen
10. Patient must be willing to provide liquid biopsy samples for the translational
research program.
11. 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
Exclusion Criteria:
1. 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.
2. Patient has received previously topoisomerase 1 inhibitors such as irinotecan, or
nal-irinotecan
3. 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
4. Patients with known, untreated and active (not stable within the last 4 weeks or
symptomatic) brain metastases and patients with leptomeningeal disease.
5. Patient meets any of the following criteria for cardiac disease:
1. Myocardial infarction or unstable angina pectoris within 6 months prior to
initiation of study treatment
2. 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
3. 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
6. 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
7. Patient has an active serious infection requiring antibiotic treatment
8. 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
9. 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
10. Patient participated in another interventional clinical study ≤ 14 days prior to
initiation of study treatment or at the same time as this study.
11. Patient has taken an investigational drug within 14 days or 5 half-lives (whichever
is longer) prior to initiation of study treatment.
12. 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.
13. Patient has not recovered from AEs due to previously administered drug (i.e., ≥
grade 2 is concerned as not recovered)
1. Patients with any grade of alopecia are an exception to this criterion and will
qualify for the study
2. If patients received major surgery, they must have recovered adequately from
the toxicity and/or complications from the intervention prior to starting study
treatment
14. 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.
15. 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
SCRI-CCCIT GmbH
Address:
City:
Salzburg
Zip:
5020
Country:
Austria
Facility:
Name:
Hämatologisch-Onkologische Praxis Eppendorf
Address:
City:
Hamburg
Zip:
20249
Country:
Germany
Facility:
Name:
Nationales Centrum für Tumorerkrankungen
Address:
City:
Heidelberg
Zip:
69120
Country:
Germany
Facility:
Name:
Universitätsklinikum Jena
Address:
City:
Jena
Zip:
07747
Country:
Germany
Facility:
Name:
Universitätsklinikum Leipzig
Address:
City:
Leipzig
Zip:
04103
Country:
Germany
Facility:
Name:
Onkopraxis Probstheida
Address:
City:
Leipzig
Zip:
04289
Country:
Germany
Facility:
Name:
Universitätsklinikum Mannheim
Address:
City:
Mannheim
Zip:
68167
Country:
Germany
Facility:
Name:
Klinikum rechts der Isar der TU München
Address:
City:
München
Zip:
81675
Country:
Germany
Start date:
April 17, 2024
Completion date:
March 2027
Lead sponsor:
Agency:
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Agency class:
Other
Collaborator:
Agency:
Gilead Sciences
Agency class:
Industry
Source:
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06123468
