Study of Safety and Efficacy of RGT-61159 in Adults With Relapsed/Refractory Adenoid Cystic Carcinoma (ACC) or Colorectal Carcinoma (CRC)
NCT ID: NCT06462183
Last Updated: 2025-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
105 participants
INTERVENTIONAL
2024-08-19
2027-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Dose escalation
RGT-61159 in escalating doses
RGT-61159
Oral MYB inhibitor
Dose expansion Cohort A
Dose optimization; RGT-61159, 2 doses, randomized allocation
RGT-61159
Oral MYB inhibitor
Dose expansion Cohort B
Simon's 2 stage, RGT-61150 at optimized dose from Part A
RGT-61159
Oral MYB inhibitor
Interventions
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RGT-61159
Oral MYB inhibitor
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Rgenta Therapeutics Inc
INDUSTRY
Responsible Party
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Locations
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Dana-Farber Cancer Institute
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Washington University School of Medicine
St Louis, Missouri, United States
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
MD Anderson Cancer Center
Houston, Texas, United States
Next Oncology VA
Fairfax, Virginia, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada
Princess Margaret Cancer Center
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Kailene Sullivan
Role: primary
Carrie Friedman, RN, BSN, OCN
Role: primary
Enrique Sanz Garcia
Role: primary
Other Identifiers
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RGT61159-01
Identifier Type: -
Identifier Source: org_study_id