Study of Safety and Efficacy of RGT-61159 in Adults With Relapsed/Refractory Adenoid Cystic Carcinoma (ACC) or Colorectal Carcinoma (CRC)

NCT06462183 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: RGT61159-01
• Study Type: interventional
• Target: 105
• Locations: 2 countries
• Sites: 10

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

Outcome Measures

Primary Outcomes (3)

• Number and type of dose-limiting toxicities (DLTs) in first cycle of administration

  21 days

• Number and type of adverse events

  Through study completion, estimated as 30 days after last dose of study drug

• Recommended Phase 2 Dose (RP2D)

  Assessed at the end of Cycle 1 for each subject (each cycle 21 days)

Study Arms (3)

Dose escalation

EXPERIMENTAL

RGT-61159 in escalating doses

Drug: RGT-61159

Dose expansion Cohort A

EXPERIMENTAL

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

Drug: RGT-61159

Dose expansion Cohort B

EXPERIMENTAL

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

Drug: RGT-61159

Interventions

RGT-61159 DRUG

Oral MYB inhibitor

Dose escalation; Dose expansion Cohort A; Dose expansion Cohort B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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

You may not qualify 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
• 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

Sponsors & Collaborators

• Rgenta Therapeutics Inc: lead

Study Sites (10)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

New York, New York, 10016, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Next Oncology VA

Fairfax, Virginia, 22031, United States

RECRUITING

Fred Hutchinson Cancer Center

Seattle, Washington, 98109, United States

RECRUITING

Ottawa Hospital Cancer Centre

Ottawa, Ontario, K1H 8L6, Canada

RECRUITING

Princess Margaret Cancer Center

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

MeSH Terms

Conditions

Carcinoma, Adenoid Cystic; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Clinical Operations

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open-label, ascending dose escalation followed by dose expansion

Study Record Dates

• First Submitted: June 7, 2024
• First Posted: June 17, 2024
• Study Start: August 19, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2027
• Last Updated: November 14, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2); US (8)