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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.

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
Advanced Malignant Solid Neoplasm RAS Mutation Lung Cancer Colon Cancer Glioblastoma Pancreatic Cancer 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : February 16, 2021
Estimated Primary Completion Date : January 16, 2024
Estimated Study Completion Date : March 5, 2024

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Adverse event profile of RSC-1255 [ Time Frame: Approximately 24 months ]
    Toxicities will be graded according to CTCAE V5.0.

  2. Overall Survival (OS) [ Time Frame: Approximately 24 months ]
    Overall Survival will be assessed using RECIST V1.1.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04678648


Contacts
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Contact: Bonnie Wettersten, MS (847) 644-9818 clinicaltrials@rascaltherapeutics.com

Locations
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United States, California
University of California, Los Angles (UCLA) Department of Medicine - Hematology/Oncology Recruiting
Los Angeles, California, United States, 90404
UC Davis Comprehensive Cancer Center Recruiting
Sacramento, California, United States, 95817
United States, Colorado
Anschutz Cancer Pavilion - University of Colorado Hospital Not yet recruiting
Aurora, Colorado, United States, 80045
Sarah Cannon Research Institute - Health One Recruiting
Denver, Colorado, United States, 80218
United States, Pennsylvania
Sidney Kimmel Cancer Center - Thomas Jefferson Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
United States, Tennessee
Sarah Cannon Tennessee Oncology Recruiting
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
RasCal Therapeutics, Inc.
Investigators
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Study Director: Robert Reder, MD RasCal Therapeutics, Inc.
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Responsible Party: RasCal Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04678648    
Other Study ID Numbers: RSC-101
First Posted: December 22, 2020    Key Record Dates
Last Update Posted: September 1, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Neoplasms
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue