study of safety and efficacy of rgt-61159 in adults with relapsed/refractory adenoid cystic carcinoma (acc) or colorectal carcinoma (crc)

Conditions: Adenoid Cystic Carcinoma; Colorectal Cancer

Summary: phase 1 study to evaluate safety, tolerability and anti-tumor activity of rgt-61159 in patients with acc or crc

this first-in-human, phase 1, multi-center, open-label, non-randomized study, is designed to evaluate safety, tolerability, and anti-tumor activity of once-daily rgt-61159 in patients with advanced r/r acc or r/r crc for whom standard therapy with proven clinical benefit does not exist, is no longer effective, or is not appropriate. rgt-61159 is an oral, small molecule myb inhibitor.

Eligibility criteria:
inclusion criteria: * 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. * adequate hematologic status, organ function, renal function, liver function and prothrombin time (pt) or inr ≤ 1.5 × uln and partial thromboplastin time (ptt) or activated partial thromboplastin time (aptt) ≤ 1.5 × uln * resolved acute effects of any prior therapy to baseline exclusion criteria: * 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 * investigational drug use, targeted therapy, or biologic therapy within 28 days or 5 half-lives, whichever is shorter, prior to cycle 1 day 1 * ongoing systemic infection requiring treatment with antibiotic, antiviral, or antifungal treatment * active known second malignancy * clinically significant cardiac disease * infection with human immunodeficiency virus (hiv)-1 or hiv-2 unless it's well-controlled hiv (eg, cluster of differentiation 4 \[cd4\] \> 350/mm3 and undetectable viral load) * current active liver disease including hepatitis a (hepatitis a \[hepa\] virus immunoglobulin m \[igm\] positive), hepatitis b (hepatitis b virus \[hbv\] surface antigen positive), or hepatitis c (hepatitis c virus \[hcv\] antibody positive, confirmed by hcv rna) * refractory nausea and vomiting, malabsorption, external biliary shunt, or significant small bowel resection that would preclude adequate absorption * uncontrolled diabetes * treatment with a long-acting hematopoietic growth factor within 14 days before cycle 1 day 1 or a short-acting hematopoietic growth factor within 7 days before cycle 1 day 1 * treatment with high-dose chemotherapy and stem-cell rescue (autologous stem cell transplant) or allogeneic stem cell transplant within 90 days before cycle 1 day 1 * patients with central nervous system (cns) metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroid throughout this indication for at least 4 weeks before starting treatment in this study * history of solid organ transplantation * coronavirus disease 2019 (covid-19) vaccination within 14 days prior to first dose of study drug * prior treatment with a myb inhibitor