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

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ClinicalTrials.gov Identifier: NCT04678648
Recruitment Status : Recruiting
First Posted : December 22, 2020
Last Update Posted : September 1, 2021
Sponsor:
Information provided by (Responsible Party):
RasCal Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE December 8, 2020
First Posted Date  ICMJE December 22, 2020
Last Update Posted Date September 1, 2021
Actual Study Start Date  ICMJE February 16, 2021
Estimated Primary Completion Date January 16, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 16, 2020)
  • Maximum Tolerated Dose (MTD) for RSC-1255 as monotherapy [ Time Frame: 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.
  • Recommended Phase 2 Dose (RP2D) for RSC-1255 as monotherapy [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2020)
  • Adverse event profile of RSC-1255 [ Time Frame: Approximately 24 months ]
    Toxicities will be graded according to CTCAE V5.0.
  • Overall Survival (OS) [ Time Frame: Approximately 24 months ]
    Overall Survival will be assessed using RECIST V1.1.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Trial of RSC-1255 for Treatment of Patients With Advanced Malignancies
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Advanced Malignant Solid Neoplasm
  • RAS Mutation
  • Lung Cancer
  • Colon Cancer
  • Glioblastoma
  • Pancreatic Cancer
Intervention  ICMJE
  • 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
Study Arms  ICMJE Experimental: RSC-1255 Treatment
Single Arm Study. All study participants receive RSC-1255.
Interventions:
  • Drug: RSC-1255 Dose Escalation
  • Drug: RSC-1255 Dose Expansion
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 16, 2020)
134
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 5, 2024
Estimated Primary Completion Date January 16, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
  2. Has evaluable or measurable tumor(s) in dose-escalation by standard radiological and/or laboratory assessments as applicable to their malignancy.
  3. Has adequate performance status (PS): Eastern Co-operative Oncology Group (ECOG).
  4. 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Bonnie Wettersten, MS (847) 644-9818 clinicaltrials@rascaltherapeutics.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04678648
Other Study ID Numbers  ICMJE RSC-101
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party RasCal Therapeutics, Inc.
Study Sponsor  ICMJE RasCal Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Robert Reder, MD RasCal Therapeutics, Inc.
PRS Account RasCal Therapeutics, Inc.
Verification Date August 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP