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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Rgenta Therapeutics Inc
Study ID
NCT06462183
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • RGT-61159 — DRUG
    Oral MYB inhibitor

Study Details

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

Key Dates

Start date
Aug 19, 2024
Status verified
Nov 2025
Primary completion
Dec 31, 2025
Completion
Jun 30, 2027

Study Design

Enrollment
105 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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

Primary Outcome Measure

Number and type of dose-limiting toxicities (DLTs) in first cycle of administration [ Time Frame: 21 days ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
Dana-Farber Cancer InstituteBostonMassachusetts02215
Kailene Sullivan
[email protected]
617-632-3482
University of MichiganAnn ArborMichigan48109-
Washington University School of MedicineSt LouisMissouri63110-
Laura & Isaac Perlmutter Cancer Center at NYU Langone HealthNew YorkNew York10016-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
MD Anderson Cancer CenterHoustonTexas77030-
Next Oncology VAFairfaxVirginia22031
Carrie Friedman, RN, BSN, OCN
[email protected]
703-636-1473
Fred Hutchinson Cancer CenterSeattleWashington98109-

Find similar trials in Boston, MA

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
Dana-Farber Cancer Institute· Boston, MAUniversity of Michigan· Ann Arbor, MIWashington University School of Medicine· St Louis, MOLaura & Isaac Perlmutter Cancer Center at NYU Langone Health· New York, NYMemorial Sloan Kettering Cancer Center· New York, NYMD Anderson Cancer Center· Houston, TX

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