Sacituzumab Govitecan in Recurrent Glioblastoma

Required: IDH1 wild-type

Histologically confirmed IDH wild type (primary) GBM

Required: IDH2 wild-type

Histologically confirmed IDH wild type (primary) GBM

Required: TACSTD2 any tested (H-Score ≥200)

Positive Trop-2 expression (H-Score ≥200), as verified by central review at University of Texas Health Science Center at San Antonio (UTHSA).

Must have received: radiation therapy — standard doses

Progression following standard combined modality treatment with radiation and temozolomide chemotherapy if O6-Methylguanine-DNA Methyltransferase (MGMT) methylated. Prior temozolomide is not required for MGMT unmethylated, but patient must have received standard doses of radiation.

Cannot have received: bevacizumab or other VEGF inhibitors or VEGF-Receptor signaling inhibitors

Prior treatment with bevacizumab or other VEGF inhibitors or VEGF-Receptor signaling inhibitors

Cannot have received: non-standard radiation therapy (brachytherapy, systemic radioisotope therapy (RIT), intra-operative radiotherapy (IORT))

Exception: stereotactic radiosurgery (SRS) is allowed

Non-standard radiation therapy such as brachytherapy, systemic radioisotope therapy (RIT), or intra-operative radiotherapy (IORT). Note: stereotactic radiosurgery (SRS) is allowed

Cannot have received: systemic therapy (including investigational agents and small-molecule kinase inhibitors) or non-cytotoxic hormonal therapy (tamoxifen)

Systemic therapy (including investigational agents and small-molecule kinase inhibitors) or non-cytotoxic hormonal therapy (eg, tamoxifen) within 7 days or 5 half-lives, whichever is shorter, prior first dose of study drug

Cannot have received: biologic agents (antibodies, immune modulators, vaccines, cytokines)

Biologic agents (antibodies, immune modulators, vaccines, cytokines) within 21 days prior to first dose of study drug

Cannot have received: nitrosoureas or mitomycin C (nitrosoureas, mitomycin C)

Nitrosoureas or mitomycin C within 42 days, or metronomic/protracted low-dose chemotherapy within 14 days, or other cytotoxic chemotherapy within 28 days, prior to first dose of study drug

Cannot have received: metronomic/protracted low-dose chemotherapy

metronomic/protracted low-dose chemotherapy within 14 days

Cannot have received: cytotoxic chemotherapy

other cytotoxic chemotherapy within 28 days

Cannot have received: carmustine wafer (carmustine wafer)

Prior treatment with carmustine wafers