FT538 in Combination With Monoclonal Antibodies in Advanced Solid Tumors (NCT05069935) | Clinical Trial Compass
TerminatedPhase 1
FT538 in Combination With Monoclonal Antibodies in Advanced Solid Tumors
Stopped: This study was terminated by the Sponsor.
United States16 participantsStarted 2021-10-15
Plain-language summary
This is a Phase 1 dose-finding study of FT538 in combination with monoclonal antibodies.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
Subjects with locally advanced or metastatic disease who have progressed after at least one line of therapy and diagnosis of one of the following by treatment cohort:
* Cohort A: The following solid tumor malignancies where anti-PD-1/PD-L1 antibodies are approved: cutaneous melanoma, non-small cell/small cell lung cancer, renal cell carcinoma, head and neck squamous cell cancer, microsatellite instability-high/ mismatch repair deficient cancer, gastric cancer, esophageal cancer, cervical cancer, merkel cell carcinoma, endometrial carcinoma, tumor mutation burden-high ≥ 10 mutations/megabase\], cutaneous squamous cell carcinoma, triple-negative breast cancer.
* Cohort B: HER2+ breast cancer that has relapsed or progressed on trastuzumab and progressed on either pertuzumab or HER2-targeting antibody drug conjugate; HER2+ gastric cancer that has relapsed or progressed on trastuzumab-containing therapy; OR any other HER2+ solid tumor having progressed on at least one line of standard-of-care therapy. For any tumor type in this cohort, HER2 status must be documented by a U.S. Food and Administration (FDA) approved test to be ≥2+ IHC or Average HER2 copy number ≥4 signals per cell by in situ hybridization.
* Cohort C: CRC having progressed following prior cetuximab treatment or has KRAS/NRAS mutation; HNSCC having progressed following prior cetuximab.
Capable of giving signed informed consent
Aged \~ 18 years old
Willingness to comply with study procedures …