Study of RGT-61159 for Adenoid Cystic Carcinoma or Colorectal Cancer
This study is testing a new oral medication called RGT-61159 for adults with advanced adenoid cystic carcinoma (ACC) or colorectal cancer (CRC). These are cancers that have returned or are no longer responding to standard treatments. RGT-61159 works by targeting a specific protein called MYB. We are looking to see how safe RGT-61159 is, how well people tolerate it, and if it shows any anti-tumor activity. To join, you must have ACC or CRC that can be measured on scans and has either returned or progressed after previous treatments. This study is currently unclear about its recruitment status and aims to enroll about 105 participants. The main goals are to find out about any side effects and to determine the best dose for future studies.
- Study design
- This is a Phase 1, multi-center, open-label study, meaning both you and your doctors will know which treatment you are receiving. It is not randomized, and about 105 participants are planned.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- You will be followed for about 30 days after your last dose of RGT-61159 to monitor for any side effects.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06462183
Study of Safety and Efficacy of RGT-61159 in Adults With Relapsed/Refractory Adenoid Cystic Carcinoma (ACC) or Colorectal Carcinoma (CRC)
Recruiting
PHASE1Ages 18+InterventionalTreatmentRgenta Therapeutics Inc
~105 participants
Updated 2025-11-14 on ClinicalTrials.gov
What's tested:RGT-61159
At a glance
Recruiting sites
10 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number and type of dose-limiting toxicities (DLTs) in first cycle of administration
Measured over 21 days
+2 more outcomes measured
Conditions
Where it's being run
10 sites across 8 statesNew York2
Ontario2
Massachusetts1
Michigan1
Missouri1
Texas1
Virginia1
Washington1
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
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
What this trial measures
- Number and type of dose-limiting toxicities (DLTs) in first cycle of administration21 days
- Number and type of adverse eventsThrough study completion, estimated as 30 days after last dose of study drug
- Recommended Phase 2 Dose (RP2D)Assessed at the end of Cycle 1 for each subject (each cycle 21 days)