Clinical Trials /

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

NCT04678648

Description:

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.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Not yet recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Trial of RSC-1255 for Treatment of Patients With Advanced Malignancies
  • 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

Clinical Trial IDs

  • ORG STUDY ID: RSC-101
  • NCT ID: NCT04678648

Conditions

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

Interventions

DrugSynonymsArms
RSC-1255 Dose EscalationPhase 1a, Dose EscalationRSC-1255 Treatment
RSC-1255 Dose ExpansionPhase 1b, Dose ExpansionRSC-1255 Treatment

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
RSC-1255 TreatmentExperimentalSingle Arm Study. All study participants receive RSC-1255.
  • RSC-1255 Dose Escalation
  • RSC-1255 Dose Expansion

Eligibility 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Maximum Tolerated Dose (MTD) for RSC-1255 as monotherapy
Time Frame:Approximately 12 months
Safety Issue:
Description: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.

Secondary Outcome Measures

Measure:Adverse event profile of RSC-1255
Time Frame:Approximately 24 months
Safety Issue:
Description:Toxicities will be graded according to CTCAE V5.0.
Measure:Overall Survival (OS)
Time Frame:Approximately 24 months
Safety Issue:
Description:Overall Survival will be assessed using RECIST V1.1.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:RasCal Therapeutics, Inc.

Trial Keywords

  • Malignancy
  • Cancer
  • Refractory
  • RAS mutation
  • Lung
  • Colon
  • Glioblastoma
  • RSC-1255
  • Progression
  • Pancreatic

Last Updated

December 22, 2020