Sacituzumab Govitecan for the Treatment for Patients With Locally Advanced, Recurrent, or Metasta… (NCT06178588) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Sacituzumab Govitecan for the Treatment for Patients With Locally Advanced, Recurrent, or Metastatic Cholangiocarcinoma
United States15 participantsStarted 2024-02-01
Plain-language summary
This phase II trial tests how well sacituzumab govitecan works in treating patients with cholangiocarcinoma that has spread to nearby tissue or lymph nodes (locally advanced), that has come back after a period of improvement (recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic). Sacituzumab govitecan is a monoclonal antibody, called hRS7, linked to a toxic agent, called SN-38. HRS7 is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of tumor cells, known as TROP2 receptors, and delivers SN-38 to kill them.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Ability of participant or legally authorized representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent
* Males and females age ≥ 18 years
* Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2
* Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
* Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days before day 1 of study treatment
* Locally advanced, recurrent or metastatic cholangiocarcinoma) after progressing or intolerant to at least one line of systemic therapy
* Adequate archival tissue from prior biopsy for biomarker evaluation or willingness to undergo tissue biopsy before treatment starts and on treatment. Patients who, in the opinion of the investigator, do not have tissue that can be safely biopsied are exempted
* Absolute neutrophil count ≥ 1.5 K/UL
* Hemoglobin ≥ 9 g/dL
* Platelets ≥ 100K/UL
* Creatinine clearance ≥ 30 mL/min as assessed by the Cockcroft-Gault equation {Cockcroft 1976} or Creatinine clearance ≥ 60 mL/min
* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) OR direct bilirubin ≤ 1 x ULN
* Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x ULN unless liver metastases are present, in which case they must be ≤ 5 x ULN
* Women of child-bearing potential and men with partners of child-bearing potential must agree to practice sexual abstinence or to use the forms of contrace…