Phase 2 Trial Of Sacituzumab Tirumotecan For Treatment Of Refractory Metastatic Or Unresectable Squamous Cell Carcinoma Of The Anus/Rectum
M.D. Anderson Cancer Center
Summary
To look at the effectiveness of sacituzumab tirumotecan (MK-2870) in treating participants with treatment-refractory unresectable and/or metastatic anal/rectal cancer.
Description
Primary Objectives To evaluate the overall response rate for Sacituzumab tirumotecan in participants with treatment refractory unresectable and/or metastatic anal cancer. Secondary Objectives * To estimate progression-free survival for Sacituzumab tirumotecan in participants with treatment refractory unresectable and/or metastatic anal cancer. * To describe the disease control rate using criteria for Sacituzumab tirumotecan in participants with treatment-refractory unresectable and/or metastatic anal cancer. * To summarize safety and tolerability using CTCAE version 5.0 for Sacituzumab tirum…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Eligibility Criteria 1. Participants must have histologically or cytologically confirmed squamous cell carcinoma of the anus or rectum that is metastatic or unresectable at the discretion of the treating investigator. 2. Participants must have measurable disease according to the standard RECIST version 1.1 as assessed by the local site investigator/radiology. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm (≥2 cm) by chest x-ray or a…
Interventions
- DrugSacituzumab Tirumotecan
Given by IV
Location
- MD Anderson Cancer CenterHouston, Texas