Actively Recruiting
Study of Safety and Efficacy of RGT-61159 in Adults With Relapsed/Refractory Adenoid Cystic Carcinoma (ACC) or Colorectal Carcinoma (CRC)
Led by Rgenta Therapeutics Inc · Updated on 2025-11-14
105
Participants Needed
10
Research Sites
145 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Phase 1 study to evaluate safety, tolerability and anti-tumor activity of RGT-61159 in patients with ACC or CRC
CONDITIONS
Official Title
Study of Safety and Efficacy of RGT-61159 in Adults With Relapsed/Refractory Adenoid Cystic Carcinoma (ACC) or Colorectal Carcinoma (CRC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed Adenoid Cystic Carcinoma or Colorectal Carcinoma
- Radiographically measurable disease with at least one measurable site not previously irradiated, or evidence of progression if previously irradiated
- Locally relapsed/refractory advanced or metastatic ACC not suitable for curative surgery or radiotherapy with disease progression within 12 months
- CRC patients with locally relapsed/refractory advanced or metastatic disease not suitable for curative surgery or radiotherapy, previously treated with or not candidates for standard therapies including fluoropyrimidines-, oxaliplatin-, irinotecan-based chemotherapies, anti-VEGF agents, and anti-EGFR therapy if RAS wild-type
- Adequate blood counts, organ, kidney, and liver function; PT/INR and PTT/aPTT less than or equal to 1.5 times upper limit of normal
- Resolved acute effects of any prior therapy to baseline
You will not qualify if you...
- Major surgery or significant traumatic injury within 28 days before starting treatment
- Chemotherapy within 14 days before starting treatment
- Use of nitrosoureas or mitomycin C within 6 weeks before starting treatment
- Radiation therapy within 21 days before starting treatment
- Use of investigational drugs, targeted therapy, or biologics within 28 days or five half-lives before starting treatment
- Ongoing systemic infection requiring antibiotic, antiviral, or antifungal treatment
- Active second malignancy
- Significant heart disease
- HIV infection unless well-controlled with CD4 > 350/mm3 and undetectable viral load
- Active liver disease including hepatitis A, B, or C
- Severe gastrointestinal problems affecting absorption
- Uncontrolled diabetes
- Use of hematopoietic growth factors within 7 to 14 days before starting treatment
- Stem cell transplant within 90 days before starting treatment
- Central nervous system metastases unless treated and off corticosteroids for at least 4 weeks
- History of solid organ transplantation
- COVID-19 vaccination within 14 days before first dose
- Prior treatment with a MYB inhibitor
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
2
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
3
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
4
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
5
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
6
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
7
Next Oncology VA
Fairfax, Virginia, United States, 22031
Actively Recruiting
8
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Actively Recruiting
9
Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada, K1H 8L6
Actively Recruiting
10
Princess Margaret Cancer Center
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
Research Team
C
Clinical Operations
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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