Trial Title:
Study of Safety and Efficacy of RGT-61159 in Adults with Relapsed/Refractory Adenoid Cystic Carcinoma (ACC) or Colorectal Carcinoma (CRC)
NCT ID:
NCT06462183
Condition:
Adenoid Cystic Carcinoma
Colorectal Cancer
Conditions: Official terms:
Carcinoma
Colorectal Neoplasms
Carcinoma, Adenoid Cystic
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Intervention model description:
Open-label, ascending dose escalation followed by dose expansion
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
RGT-61159
Description:
Oral MYB inhibitor
Arm group label:
Dose escalation
Arm group label:
Dose expansion Cohort A
Arm group label:
Dose expansion Cohort B
Summary:
Phase 1 study to evaluate safety, tolerability and anti-tumor activity of RGT-61159 in
patients with ACC or CRC
Detailed description:
This first-in-human, Phase 1, multi-center, open-label, non-randomized study, is designed
to evaluate safety, tolerability, and anti-tumor activity of once-daily RGT-61159 in
patients with advanced R/R ACC or R/R CRC for whom standard therapy with proven clinical
benefit does not exist, is no longer effective, or is not appropriate. RGT-61159 is an
oral, small molecule MYB inhibitor.
Criteria for eligibility:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Dana-Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kailene Sullivan
Phone:
617-632-3482
Email:
kailene_sullivan@dfci.harvard.edu
Facility:
Name:
Washington University School of Medicine
Address:
City:
St Louis
Zip:
63110
Country:
United States
Status:
Recruiting
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Facility:
Name:
MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Facility:
Name:
Next Oncology VA
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Contact:
Last name:
Carrie Friedman, RN, BSN, OCN
Phone:
703-636-1473
Email:
carrie.friedman@usoncology.com
Facility:
Name:
Ottawa Hospital Cancer Centre
Address:
City:
Ottawa
Zip:
K1H 8L6
Country:
Canada
Status:
Recruiting
Facility:
Name:
Princess Margaret Cancer Center
Address:
City:
Toronto
Zip:
M5G 2M9
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Enrique Sanz Garcia
Phone:
416-946-4501
Phone ext:
3617
Email:
enrique.sanzgarcia@uhn.ca
Start date:
August 19, 2024
Completion date:
June 2027
Lead sponsor:
Agency:
Rgenta Therapeutics Inc
Agency class:
Industry
Source:
Rgenta Therapeutics Inc
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06462183
