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

Sponsor
RasCal Therapeutics, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04678648
Collaborator
(none)
134
Enrollment
6
Locations
1
Arm
36.6
Anticipated Duration (Months)
22.3
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

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 disease that has progressed after standard therapy, or have previously failed other therapies. The study has two phases. The purpose of Phase 1a (Dose Escalation) is to confirm the appropriate treatment dose and Phase 1b (Dose Expansion) is to characterize the safety and efficacy of RSC-1255.

Condition or Disease Intervention/Treatment Phase
  • Drug: RSC-1255 Dose Escalation
  • Drug: RSC-1255 Dose Expansion
 Phase 1

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 study in participants with advanced solid tumor malignancies. Study enrollment is approximately 134 participants. All participants receive oral RSC-1255, twice daily as monotherapy. Following Phase 1a (Dose Escalation) to identify the Maximum Tolerated Dose and Recommended Dose for use in Phase 1b, additional participants are enrolled in the Phase 1b (Dose Expansion) to further characterize the safety, pharmacology, and the clinical efficacy of RSC-1255.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
134 participants
Allocation:
N/A
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase Ia/Ib, Open Label, Multi-center, Non-randomized Dose Escalation and Dose Expansion Study of RSC-1255 in Patients With Advanced Solid Tumor Malignancies
Actual Study Start Date :
Feb 16, 2021
Anticipated Primary Completion Date :
Jan 16, 2024
Anticipated Study Completion Date :
Mar 5, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: RSC-1255 Treatment

Single Arm Study. All study participants receive RSC-1255.

Drug: RSC-1255 Dose Escalation
Phase 1a will enroll 24-34 participants to identify the dose limiting toxicity (DLT), recommended Phase 1b dose, and the safety and tolerability of RSC-1255. RSC-1255 is administered orally twice daily, without food. Each cycle is 21 days.
Other Names:
  • Phase 1a
  • Dose Escalation

    • Drug: RSC-1255 Dose Expansion
    Phase 1b will enroll 48-104 participants to further characterize the safety, pharmacology, and clinical efficacy of RSC-1255. RSC-1255 is administered orally twice daily, without food. Each cycle is 21 days.
    Other Names:
  • Phase 1b
  • Dose Expansion

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Maximum Tolerated Dose (MTD) for RSC-1255 as monotherapy [Approximately 12 months]

      The number and type of dose-limiting toxicities (DLTs) as defined in the protocol that occur during the first 28 days of treatment and all maximum grade of all maximum grade of all treatment-related events using CTCAE V5.0 will be used to identify a safe and tolerable dose.

    2. Recommended Phase 2 Dose (RP2D) for RSC-1255 as monotherapy [Approximately 12 months]

      The number and type of DLTs as defined in the protocol that occur during the first 28 days of treatment and all maximum grade of all treatment-related adverse events using CTCAE 5.0 will be used to identify a safe and tolerable dose.

    Secondary Outcome Measures

    1. Adverse event profile of RSC-1255 [Approximately 24 months]

      Toxicities will be graded according to CTCAE V5.0.

    2. Overall Survival (OS) [Approximately 24 months]

      Overall Survival will be assessed using RECIST V1.1.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria (Key Factors):
    1. 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

    1. Has evaluable or measurable tumor(s) in dose-escalation by standard radiological and/or laboratory assessments as applicable to their malignancy.

    2. Has adequate performance status (PS): Eastern Co-operative Oncology Group (ECOG).

    3. Is age ≥ 18 years.

    Exclusion Criteria (Key Factors):

    1. Participants receiving cancer therapy at the time of enrollment.

    2. Any clinically significant disease or condition affecting a major organ system.

    3. Significant cardiovascular disease or electrocardiogram (ECG) abnormalities.

    4. Known Gilbert's disease.

    5. Has had a previous (within 2 years) or has a current malignancy other than the target cancer.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of California, Los Angles (UCLA) Department of Medicine - Hematology/Oncology Los Angeles California United States 90404
    2 UC Davis Comprehensive Cancer Center Sacramento California United States 95817
    3 Anschutz Cancer Pavilion - University of Colorado Hospital Aurora Colorado United States 80045
    4 Sarah Cannon Research Institute - Health One Denver Colorado United States 80218
    5 Sidney Kimmel Cancer Center - Thomas Jefferson Hospital Philadelphia Pennsylvania United States 19107
    6 Sarah Cannon Tennessee Oncology Nashville Tennessee United States 37203

    Sponsors and Collaborators

    • RasCal Therapeutics, Inc.

    Investigators

    • Study Director: Robert Reder, MD, RasCal Therapeutics, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    RasCal Therapeutics, Inc.
    ClinicalTrials.gov Identifier:
    NCT04678648
    Other Study ID Numbers:
    • RSC-101
    First Posted:
    Dec 22, 2020
    Last Update Posted:
    Jan 5, 2022
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by RasCal Therapeutics, Inc.
    Malignancy
    Cancer
    Refractory
    RAS mutation
    Lung
    Colon
    Glioblastoma
    RSC-1255
    Progression
    Pancreatic
    Additional relevant MeSH terms:
    Neoplasms
    Glioblastoma

    Study Results

    No Results Posted as of Jan 5, 2022