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

NCT06123468 | Completed Phase 1

• 4 other identifiers: SAGA2023-505257-40-00AIO-STO-0123/ass.IKF-t065
• Study Type: interventional
• Target: 58
• Locations: 2 countries
• Sites: 8

Brief Summary

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

Conditions

Esophagogastric Adenocarcinoma

Keywords

gastric adenocarcinoma; GEJ adenocarcinoma

Outcome Measures

Primary Outcomes (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).

  up to 12 months

Secondary Outcomes (4)

• Clinical benefit rate

  up to 36 months

• Progression-free survival (PFS)

  up to 36 months

• Overall survival (OS)

  up to 36 months

• Safety and toxicity

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

Study Arms (1)

Sacituzumab-govitecan

EXPERIMENTAL

Single 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.

Drug: Sacituzumab govitecan

Interventions

Sacituzumab govitecan DRUG

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)

Also known as: Trodelvy

Sacituzumab-govitecan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest: lead
• Gilead Sciences: collaborator

Study Sites (8)

SCRI-CCCIT GmbH

Salzburg, 5020, Austria

Location

Hämatologisch-Onkologische Praxis Eppendorf

Hamburg, 20249, Germany

Location

Nationales Centrum für Tumorerkrankungen

Heidelberg, 69120, Germany

Location

Universitätsklinikum Jena

Jena, 07747, Germany

Location

Universitätsklinikum Leipzig

Leipzig, 04103, Germany

Location

Onkopraxis Probstheida

Leipzig, 04289, Germany

Location

Universitätsklinikum Mannheim

Mannheim, 68167, Germany

Location

Klinikum rechts der Isar der TU München

München, 81675, Germany

Location

Related Publications (1)

• 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.

  PMID: 41648033 DERIVED

MeSH Terms

Interventions

sacituzumab govitecan

Study Officials

• Salah Al-Batran, Prof. Dr.

  Frankfurter Institut für Klinische Krebsforschung IKF GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 6, 2023
• First Posted: November 8, 2023
• Study Start: April 17, 2024
• Primary Completion: January 7, 2026
• Study Completion: January 7, 2026
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (7); AU (1)