Evaluating a new treatment for advanced adenoid cystic carcinoma and colorectal cancer
A Phase 1a/1b, First-in-human, Multicenter Study to Assess the Efficacy and Safety of RGT-61159 for Treatment of Patients With Relapsed/Refractory Adenoid Cystic Carcinoma (ACC) or Colorectal Carcinoma (CRC)
This study is testing a new oral medication called RGT-61159 to see if it can help adults with advanced adenoid cystic carcinoma or colorectal cancer whose treatments haven't worked.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 105 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rgenta Therapeutics Inc Industry-sponsored |
| Drugs / interventions | Chemotherapy, radiation |
| Locations | 10 sites (Boston, Massachusetts and 9 other locations) |
| Trial ID | NCT06462183 on ClinicalTrials.gov |
What this trial studies
This Phase 1 clinical trial aims to assess the safety, tolerability, and anti-tumor activity of RGT-61159, an oral MYB inhibitor, in adults with relapsed or refractory adenoid cystic carcinoma (ACC) or colorectal carcinoma (CRC). The study is open-label and non-randomized, focusing on patients whose disease has progressed despite standard therapies. Participants will receive RGT-61159 once daily, and the trial will measure the drug's effectiveness in shrinking tumors and improving patient outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults with histologically confirmed advanced adenoid cystic carcinoma or colorectal carcinoma that is not amenable to curative surgery or radiotherapy.
Not a fit: Patients with early-stage cancer or those who have not exhausted standard treatment options may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced ACC or CRC who have limited or no effective treatment alternatives.
How similar studies have performed: While this approach is novel in targeting MYB inhibition for these specific cancers, similar studies have shown promise in other malignancies, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 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 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 this trial is running
Boston, Massachusetts and 9 other locations
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
- Washington University School of Medicine — St Louis, Missouri, United States (Recruiting)
- Laura & Isaac Perlmutter Cancer Center at NYU Langone Health — New York, New York, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
- MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
- Next Oncology VA — Fairfax, Virginia, United States (Recruiting)
- Fred Hutchinson Cancer Center — Seattle, Washington, United States (Recruiting)
- Ottawa Hospital Cancer Centre — Ottawa, Ontario, Canada (Recruiting)
- Princess Margaret Cancer Center — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Clinical Operations
- Email: Clinical-Operations@rgentatx.com
- Phone: 857-225-2840
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.