A Phase I / II, Open-Label Study of REC-1245 in Participants with Unresectable, Locally Advanced, or Metastatic Cancer

Study Identifier:
REC-1245-101
CT.gov Identifier:
NCT06678659
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Recruiting

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Study Summary

To investigate the safety, tolerability, PK, PD, and preliminary activity of REC-1245 administered orally on a once daily (QD) schedule in participants with unresectable, locally advanced, or metastatic solid tumors.

To characterize the safety, tolerability, PK, PD, and preliminary activity (ORR) of REC-1245 and to identify the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D).

Following the completion of Part 1A (monotherapy dose-finding), up to two previously examined dose levels will be randomized 1:1 in the monotherapy dose confirmation (Part 1B) portion of the study to determine the RP2D. The Phase 2 portion of this study will independently enroll one or more cohorts in parallel at the chosen RP2D dose.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Metastatic Cancer
  • Lymphoma
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I/II
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: Phase 1a
    • Read More
  • Drug: Experimental: Phase 1b Dose #1
  • Drug: Experimental: Phase 1b Dose #2
  • Drug: Experimental: Phase 2
  • Drug: REC-1245 will be administered orally on a once daily (QD) schedule
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    Inclusion criteria
    • 18 years or older
    • Have histologically-confirmed unresectable, locally advanced, or metastatic select solid tumors or select relapsed / refractory lymphoma
    • Have experienced progressive disease, relapsed disease, or be intolerant to at least one established standard systemic anti-cancer treatment for a given tumor type, or have been considered ineligible for standard therapy.
    • Eastern cooperative oncology group (ECOG) performance status ≤ 1
    • Measurable disease at baseline per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 / Lugano criteria and documented by computed tomography (CT) and / or magnetic resonance imaging (MRI)
    Exclusion criteria
    • * Received treatment with another RBM39 degrader Clinically significant gastrointestinal (GI) or GI malabsorption

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Mountain Region
    West Valley City, UT, United States, 84119
    Investigator
    William McKean
    Status
    Recruiting
    Condition(s) Treated at Site
    Metastatic Cancer
    Lymphoma