Treatment of advanced cancers with RSC-1255

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates RSC-1255, an oral small-molecule inhibitor targeting RAS mutations, in adults with advanced solid tumors who have not responded to existing therapies. The trial consists of two phases: Phase 1a focuses on determining the maximum tolerated dose, while Phase 1b aims to assess the safety and efficacy of the drug. Approximately 134 participants will receive RSC-1255 twice daily as monotherapy. The study is open-label and multi-center, allowing for a diverse participant pool.

Why it matters

Who can join: the full rules

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

Where it's running

• University of California, Los Angeles (UCLA) Department of Medicine - Hematology/Oncology
  Los Angeles, California, United States Recruiting
• Sarah Cannon, SCRI Oncology Partners - Health One
  Denver, Colorado, United States Recruiting
• Sarah Cannon, SCRI Oncology Partners
  Nashville, Tennessee, United States Recruiting

Study contacts

• Study coordinator: Michael Mann, MD
• Email: clinicaltrials@rascaltherapeutics.com
• Phone: 310-498-7171

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.