RecruitingPhase 1NCT04678648

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

A Phase Ia/Ib, Open Label, Multi-center, Non-randomized Dose Escalation and Dose Expansion Study of RSC-1255 Alone or in Combination With Hydroxychloroquine in Patients With Advanced Solid Tumor Malignancies

Sponsor

RasCal Therapeutics, Inc.

Enrollment

134 participants

Start Date

Mar 3, 2021

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called RSC-1255 in patients with advanced or metastatic cancers that have stopped responding to existing treatments. RSC-1255 targets specific genetic characteristics of tumors, regardless of where in the body the cancer originated — an approach called 'tissue agnostic' or 'tumor agnostic' therapy. **You may be eligible if you:** - Are 18 years of age or older - Have a confirmed advanced or metastatic cancer that has progressed on or become resistant to standard treatments - Have measurable or evaluable tumors on scans or lab tests - Are in adequate health (ECOG performance status) - Have a tumor with specific molecular characteristics targeted by this study **You may NOT be eligible if you:** - Have not yet tried standard available treatments for your cancer - Have poor organ function (kidney, liver, blood) - Have active brain metastases not controlled with prior treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRSC-1255 Dose Escalation

Phase 1a will enroll 40-80 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, with and without food. Each cycle is 21 days.

DRUGRSC-1255 Dose Expansion

Phase 1b will enroll 48-94 participants to further characterize the safety, pharmacology, and clinical efficacy of RSC-1255. RSC-1255 is administered orally twice daily alone or in combination with continuous hydroxychloroquine, with food. Each cycle is 21 days.

Locations(3)

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

Los Angeles, California, United States

Sarah Cannon, SCRI Oncology Partners - Health One

Denver, Colorado, United States

Sarah Cannon, SCRI Oncology Partners

Nashville, Tennessee, United States

View Full Details on ClinicalTrials.gov

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NCT04678648

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