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About
The study is a open-label, single-arm, multicenter, phase Ib/II trial assessing the efficacy of sacituzumab-govitecan for metastatic esophagogastric adenocarcinoma
Full 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.
Enrollment
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Volunteers
Inclusion criteria
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.
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:
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
Exclusion criteria
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:
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)
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.
Primary purpose
Allocation
Interventional model
Masking
56 participants in 1 patient group
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Central trial contact
Sabine Junge; Florian Lordick, Prof.Dr.
Data sourced from clinicaltrials.gov
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