Treatment of advanced cancers with RSC-1255
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
This study is testing a new oral drug called RSC-1255 to see if it can help adults with advanced cancers that haven't responded to other treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 134 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | RasCal Therapeutics, Inc. Industry-sponsored |
| Locations | 3 sites (Los Angeles, California and 2 other locations) |
| Trial ID | NCT04678648 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with advanced solid tumors that are refractory to or have progressed after standard therapies.
Not a fit: Patients currently receiving cancer therapy or those with significant comorbidities affecting major organ systems may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new option for patients with advanced malignancies who have limited therapeutic alternatives.
How similar studies have performed: While this approach is novel in its specific targeting of RAS mutations, similar studies targeting advanced malignancies have shown promise in the past.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Los Angeles, California and 2 other locations
- 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: Bonnie Wettersten, MS
- Email: clinicaltrials@rascaltherapeutics.com
- Phone: (847) 644-9818
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.