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

RecruitingPhase 1

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

Who can join

Ages 18 and older · All sexes

Full 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.
5. Has either tissue agnostic tumors and documented RAS mutations or with glioblastoma with or without mutation in RAS

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.
6. Intermittent hypokalemia
7. Grade 1 or higher nausea, vomiting, diarrhea at baseline due to underlying disease

About the study

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.

What is being tested

Sponsor: RasCal Therapeutics, Inc. · Participants: 134 · Started: Mar 3, 2021

Contact the study team

Official record on ClinicalTrials.gov — NCT04678648

Locations in the U.S.

CaliforniaUniversity of California, Los Angeles (UCLA) Department of Medicine - Hematology/Oncology, Los Angeles
ColoradoSarah Cannon, SCRI Oncology Partners - Health One, Denver
TennesseeSarah Cannon, SCRI Oncology Partners, Nashville

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.