Study of Safety and Efficacy of RGT-61159 in Adults with Relapsed/Refractory Adenoid Cystic Carcinoma (ACC) or Colorectal Carcinoma (CRC)

Inclusion Criteria:

• Histologically confirmed ACC or CRC

• Radiographically measurable disease as assessed per RECIST 1.1, with at least 1 siteof disease that is measurable and that has not been previously irradiated; or, ifthe patient has had previous radiation to the target lesion(s), there must beevidence of progression since the radiation

• Patients with locally relapsed/refractory (R/R) advanced or metastatic ACC notamenable to potentially curative surgery or radiotherapy and progression of diseasewithin 12 months at study entry

• Patients with CRC must have locally R/R advanced or metastatic disease not amenableto potentially curative surgery or radiotherapy; must have been previously treatedwith, or are not considered candidates for, available therapies includingfluoropyrimidines-, oxaliplatin-, and irinotecan-based chemotherapies, anti-VEGFagents, and if RAS wild-type, an anti-EGFR therapy.

• Adequate hematologic status, organ function, renal function, liver function andprothrombin time (PT) or INR ≤ 1.5 × ULN and partial thromboplastin time (PTT) oractivated 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 5half-lives, whichever is shorter, prior to Cycle 1 Day 1

• Ongoing systemic infection requiring treatment with antibiotic, antiviral, orantifungal treatment

• Active known second malignancy

• Clinically significant cardiac disease

• Infection with human immunodeficiency virus (HIV)-1 or HIV-2 unless it'swell-controlled HIV (eg, cluster of differentiation 4 [CD4] > 350/mm3 andundetectable viral load)

• Current active liver disease including hepatitis A (hepatitis A [HepA] virusimmunoglobulin M [IgM] positive), hepatitis B (hepatitis B virus [HBV] surfaceantigen positive), or hepatitis C (hepatitis C virus [HCV] antibody positive,confirmed by HCV RNA)

• Refractory nausea and vomiting, malabsorption, external biliary shunt, orsignificant 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 1Day 1

• Treatment with high-dose chemotherapy and stem-cell rescue (autologous stem celltransplant) or allogeneic stem cell transplant within 90 days before Cycle 1 Day 1

• Patients with central nervous system (CNS) metastases are not eligible, unless theyhave completed local therapy and have discontinued the use of corticosteroidthroughout this indication for at least 4 weeks before starting treatment in thisstudy

• History of solid organ transplantation

• Coronavirus disease 2019 (COVID-19) vaccination within 14 days prior to first doseof study drug

• Prior treatment with a MYB inhibitor