Recruiting
Phase 1

RGT-61159

Sponsor:

Rgenta Therapeutics Inc

Code:

NCT06462183

Conditions

Adenoid Cystic Carcinoma

Colorectal Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

RGT-61159

Study Details

Brief summary:

Phase 1 study to evaluate safety, tolerability and anti-tumor activity of RGT-61159 in patients with ACC or CRC

Conditions

Adenoid Cystic Carcinoma

Colorectal Cancer

Study ID

NCT06462183

Start date

Aug 19, 2024

Status verified date

Nov, 2025

Completion date

Jun, 2027

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

105 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dose escalation

RGT-61159 in escalating doses

experimental: Dose expansion Cohort A

Dose optimization; RGT-61159, 2 doses, randomized allocation

experimental: Dose expansion Cohort B

Simon's 2 stage, RGT-61150 at optimized dose from Part A

Interventions

RGT-61159

Oral MYB inhibitor

Primary outcome measure

  • Number and type of dose-limiting toxicities (DLTs) in first cycle of administration [ Time Frame: 21 days ]
  • Number and type of adverse events [ Time Frame: Through study completion, estimated as 30 days after last dose of study drug ]
  • Recommended Phase 2 Dose (RP2D) [ Time Frame: Assessed at the end of Cycle 1 for each subject (each cycle 21 days) ]

Central Contacts and Locations

Central contacts

Clinical Operations

857-225-2840Clinical-Operations@rgentatx.com

Locations

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Kailene Sullivan

617-632-3482kailene_sullivan@dfci.harvard.edu

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

Recruiting

New York, New York, United States, 10016

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Next Oncology VA

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Carrie Friedman, RN, BSN, OCN

703-636-1473carrie.friedman@usoncology.com

Fred Hutchinson Cancer Center

Recruiting

Seattle, Washington, United States, 98109

Ottawa Hospital Cancer Centre

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Princess Margaret Cancer Center

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

Enrique Sanz Garcia

416-946-4501

More Information

Sponsor

Rgenta Therapeutics Inc

Last update posted

Nov 14, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Rgenta Therapeutics Inc on 2025-11-14.