Back to resultsA Trial of RSC-1255 for Treatment of Patients With Advanced Malignancies
Primary Purpose
Advanced Malignant Solid Neoplasm, RAS Mutation, Lung Cancer
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
RSC-1255 Dose Escalation
RSC-1255 Dose Expansion
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Malignant Solid Neoplasm focused on measuring Malignancy, Cancer, Refractory, RAS mutation, Lung, Colon, Glioblastoma, RSC-1255, Progression, Pancreatic
Eligibility Criteria
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.
Sites / Locations
- University of California, Los Angles (UCLA) Department of Medicine - Hematology/OncologyRecruiting
- UC Davis Comprehensive Cancer CenterRecruiting
- Anschutz Cancer Pavilion - University of Colorado HospitalRecruiting
- Sarah Cannon Research Institute - Health OneRecruiting
- Sidney Kimmel Cancer Center - Thomas Jefferson HospitalRecruiting
- Sarah Cannon Tennessee OncologyRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
RSC-1255 Treatment
Arm Description
Single Arm Study. All study participants receive RSC-1255.
Outcomes
Primary Outcome Measures
Maximum Tolerated Dose (MTD) for RSC-1255 as monotherapy
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
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
Adverse event profile of RSC-1255
Toxicities will be graded according to CTCAE V5.0.
Overall Survival (OS)
Overall Survival will be assessed using RECIST V1.1.
Full Information
NCT ID
NCT04678648
First Posted
December 8, 2020
Last Updated
October 24, 2022
Sponsor
RasCal Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04678648
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 16, 2021 (Actual)
Primary Completion Date
January 16, 2024 (Anticipated)
Study Completion Date
March 5, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RasCal Therapeutics, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Malignant Solid Neoplasm, RAS Mutation, Lung Cancer, Colon Cancer, Glioblastoma, Pancreatic Cancer
Keywords
Malignancy, Cancer, Refractory, RAS mutation, Lung, Colon, Glioblastoma, RSC-1255, Progression, Pancreatic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
134 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
RSC-1255 Treatment
Arm Type
Experimental
Arm Description
Single Arm Study. All study participants receive RSC-1255.
Intervention Type
Drug
Intervention Name(s)
RSC-1255 Dose Escalation
Other Intervention Name(s)
Phase 1a, Dose Escalation
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
RSC-1255 Dose Expansion
Other Intervention Name(s)
Phase 1b, Dose Expansion
Intervention Description
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.
Primary Outcome Measure Information:
Title
Maximum Tolerated Dose (MTD) for RSC-1255 as monotherapy
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.
Time Frame
Approximately 12 months
Title
Recommended Phase 2 Dose (RP2D) for RSC-1255 as monotherapy
Description
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.
Time Frame
Approximately 12 months
Secondary Outcome Measure Information:
Title
Adverse event profile of RSC-1255
Description
Toxicities will be graded according to CTCAE V5.0.
Time Frame
Approximately 24 months
Title
Overall Survival (OS)
Description
Overall Survival will be assessed using RECIST V1.1.
Time Frame
Approximately 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bonnie Wettersten, MS
Phone
(847) 644-9818
Email
clinicaltrials@rascaltherapeutics.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Reder, MD
Organizational Affiliation
RasCal Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of California, Los Angles (UCLA) Department of Medicine - Hematology/Oncology
City
Los Angeles
State/Province
California
ZIP/Postal Code
90404
Country
United States
Individual Site Status
Recruiting
Facility Name
UC Davis Comprehensive Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Recruiting
Facility Name
Anschutz Cancer Pavilion - University of Colorado Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Name
Sarah Cannon Research Institute - Health One
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Individual Site Status
Recruiting
Facility Name
Sidney Kimmel Cancer Center - Thomas Jefferson Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Name
Sarah Cannon Tennessee Oncology
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
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A Trial of RSC-1255 for Treatment of Patients With Advanced Malignancies
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