BridgeMD
Tests treatment safety and results for Adenoid Cystic Carcinoma
Official title Study of Safety and Efficacy of RGT-61159 in Adults With Relapsed/Refractory Adenoid Cystic Carcinoma (ACC) or Colorectal Carcinoma (CRC)
ClinicalTrials.gov ID: NCT06462183
What this study is testing
What is RGT-61159?
RGT-61159 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for adenoid cystic carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Phase 1 study to evaluate safety, tolerability and anti-tumor activity of RGT-61159 in patients with ACC or CRC
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- Patients with locally relapsed/refractory (R/R) advanced or metastatic ACC not amenable to potentially curative surgery or radiotherapy and...
- Patients with CRC must have locally R/R advanced or metastatic disease not amenable to potentially curative surgery or radiotherapy; must have been...
- Adequate hematologic status, organ function, renal function, liver function and prothrombin time (PT) or INR ≤ 1.5 × ULN and partial thromboplastin...
You likely can't join 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
See the full eligibility 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...
- 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...
- 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
- 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]...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- St Louis, Missouri, United States
- New York, New York, United States
- Houston, Texas, United States
- Fairfax, Virginia, United States
- Seattle, Washington, United States
- Ottawa, Ontario, Canada
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States; Ann Arbor, Michigan, United States; St Louis, Missouri, United States; New York, New York, United States; Houston, Texas, United States; Fairfax, Virginia, United States and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.