Phase 1 study to evaluate safety, tolerability and anti-tumor activity of RGT-61159 in patients with ACC or CRC
Histologically confirmed ACC or CRC
Radiographically measurable disease as assessed per RECIST 1.1, with at least 1 site of disease that is measurable and that has not been previously irradiated; or, if the patient has had previous radiation to the target lesion(s), there must be evidence of progression since the radiation
Patients with locally relapsed/refractory (R/R) advanced or metastatic ACC not amenable to potentially curative surgery or radiotherapy and progression of disease within 12 months at study entry
Patients with CRC must have locally R/R advanced or metastatic disease not amenable to potentially curative surgery or radiotherapy; must have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidines-, oxaliplatin-, and irinotecan-based chemotherapies, anti-VEGF agents, and if RAS wild-type, an anti-EGFR therapy.
Major surgery or significant traumatic injury within 28 days prior to Cycle 1 Day 1
Chemotherapy within 14 days prior to Cycle 1 Day 1
Use of nitrosoureas or mitomycin C within 6 weeks prior to Cycle 1 Day 1
Radiation therapy within 21 days prior to Cycle 1 Day 1
Single group
RGT-61159
DrugOral MYB inhibitor
Number and type of dose-limiting toxicities (DLTs) in first cycle of administration
Number and type of adverse events
Recommended Phase 2 Dose (RP2D)
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