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

Recruiting now · Phase 1

Conditions studied: Adenoid Cystic Carcinoma, Colorectal Cancer

In brief

Phase 1 study to evaluate safety, tolerability and anti-tumor activity of RGT-61159 in patients with ACC or CRC

Key facts

Study ID

NCT06462183

Run by

Rgenta Therapeutics Inc

People needed

105

Starts

2024-08-19

Expected to finish

2027-06-01

Last updated by the study team

2025-11-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Dana-Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
• University of Michigan — Ann Arbor, Michigan, United States (enrolling)
• Washington University School of Medicine — St Louis, Missouri, United States (enrolling)
• Laura & Isaac Perlmutter Cancer Center at NYU Langone Health — New York, New York, United States (enrolling)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
• MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
• Next Oncology VA — Fairfax, Virginia, United States (enrolling)
• Fred Hutchinson Cancer Center — Seattle, Washington, United States (enrolling)
• Ottawa Hospital Cancer Centre — Ottawa, Ontario, Canada (enrolling)
• Princess Margaret Cancer Center — Toronto, Ontario, Canada (enrolling)

Full record on ClinicalTrials.gov

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