Thinking of joining a study?

Register your interest

Become a volunteer?

NCT04678648 | RECRUITING | Advanced Malignant Solid Neoplasm

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

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

Advanced Malignant Solid Neoplasm

RAS Mutation

Lung Cancer

Colon Cancer

Glioblastoma

Pancreatic Cancer

Intervention/treatment

RSC-1255 Dose Escalation

RSC-1255 Dose Expansion

Phase

PHASE1

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 : INTERVENTIONAL
Estimated Enrollment : 134 participants
Masking : NONE
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 : 2021-03-03
Estimated Primary Completion Date : 2026-12-15
Estimated Study Completion Date : 2027-01-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
A Trial of RSC-1255 for Treatment of Patients With Advanced Malignancies

Location Details

NCT04678648

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

University of California, Los Angles (UCLA) Department of Medicine - Hematology/Oncology

Los Angeles, California, United States, 90404

RECRUITING

United States, Colorado

Sarah Cannon, SCRI Oncology Partners - Health One

Denver, Colorado, United States, 80218

RECRUITING

United States, Tennessee

Sarah Cannon, SCRI Oncology Partners

Nashville, Tennessee, United States, 37203