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

a study on Solid Neoplasm RAS Mutation Lung Cancer Colon Cancer Colorectal Cancer Astrocytoma Glioblastoma Glioma Pancreatic Cancer Solid Tumor Lung Tumor Colorectal Tumor Pancreatic Neoplasms Neoplasms

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
study ends around

Description

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.

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

Details

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.

Keywords

Advanced Malignant Solid Neoplasm, RAS Mutation, Lung Cancer, Colon Cancer, Glioblastoma, Pancreatic Cancer, Malignancy, Cancer, Refractory, Lung, Colon, RSC-1255, Progression, Pancreatic, Lung Neoplasms, Colonic Neoplasms, Pancreatic Neoplasms, Neoplasms, Disease Progression, RSC-1255 Dose Escalation, RSC-1255 Dose Expansion

Eligibility

You can join if…

Open to people ages 18 years and up

(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.

You CAN'T join if...

(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.

Locations

  • University of California, Los Angles (UCLA) Department of Medicine - Hematology/Oncology accepting new patients
    Los Angeles 5368361 California 5332921 90404 United States
  • Sarah Cannon, SCRI Oncology Partners - Health One accepting new patients
    Denver 5419384 Colorado 5417618 80218 United States
  • Sarah Cannon, SCRI Oncology Partners accepting new patients
    Nashville 4644585 Tennessee 4662168 37203 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
RasCal Therapeutics, Inc.
ID
NCT04678648
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 134 study participants
Last Updated