Status:

RECRUITING

A Trial of RSC-1255 for Treatment of Patients With Advanced Malignancies

Lead Sponsor:

RasCal Therapeutics, Inc.

Conditions:

Advanced Malignant Solid Neoplasm

RAS Mutation

Eligibility:

All Genders

18+ years

Phase:

PHASE1

Brief Summary

RSC-101 is a Phase 1a/1b clinical trial of RSC-1255 in adult study participants with advanced solid tumor malignancies who are intolerant of existing therapies known to provide clinical benefit, have ...

Detailed Description

RSC-1255 is an orally bioavailable, small-molecule direct pan-mutant and wild-type RAS inhibitor. RSC-101 is a Phase 1a/1b, open-label, multi-center, non-randomized, Dose Escalation and Dose Expansion...

Eligibility Criteria

Inclusion

  • Inclusion Criteria (Key Factors):
  • Has pathologically confirmed advanced or metastatic malignancy characterized by one or more of the following:
  • Participant is intolerant of existing therapy(ies) known to provide clinical benefit for their condition
  • Malignancy is refractory to existing therapy(ies) known to potentially provide clinical benefit
  • Malignancy has progressed on standard therapy
  • Has evaluable or measurable tumor(s) in dose-escalation by standard radiological and/or laboratory assessments as applicable to their malignancy.
  • Has adequate performance status (PS): Eastern Co-operative Oncology Group (ECOG).
  • Is age ≥ 18 years.
  • Exclusion Criteria (Key Factors):
  • Participants receiving cancer therapy at the time of enrollment.
  • Any clinically significant disease or condition affecting a major organ system.
  • Significant cardiovascular disease or electrocardiogram (ECG) abnormalities.
  • Known Gilbert's disease.
  • Has had a previous (within 2 years) or has a current malignancy other than the target cancer.

Exclusion

    Key Trial Info

    Start Date :

    March 3 2021

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    January 30 2027

    Estimated Enrollment :

    134 Patients enrolled

    Trial Details

    Trial ID

    NCT04678648

    Start Date

    March 3 2021

    End Date

    January 30 2027

    Last Update

    May 8 2025

    Active Locations (3)

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    Page 1 of 1 (3 locations)

    1

    University of California, Los Angles (UCLA) Department of Medicine - Hematology/Oncology

    Los Angeles, California, United States, 90404

    2

    Sarah Cannon, SCRI Oncology Partners - Health One

    Denver, Colorado, United States, 80218

    3

    Sarah Cannon, SCRI Oncology Partners

    Nashville, Tennessee, United States, 37203