Advanced Malignant Solid Neoplasm study: RSC-1255 Dose Escalation vs RSC-1255 Dose Expansion
Official title A Trial of RSC-1255 for Treatment of Patients With Advanced Malignancies
ClinicalTrials.gov ID: NCT04678648
What this study is testing
What is RSC-1255?
An investigational oral medicine being studied for advanced malignant solid tumors.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether RSC-1255 is safe and may help people with advanced cancers that have not worked with other medicines.
- Who it's for
- You may be able to join if you are an adult with a solid tumor cancer that has progressed after standard therapy and you cannot tolerate other treatments.
- What's involved
- You will receive RSC-1255 in a hospital setting. The study will monitor your health and check for side effects and any changes in your cancer.
- Time commitment
- The study lasts about 6 months, with regular visits and tests to track your progress.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
- Has evaluable or measurable tumor(s) in dose-escalation by standard radiological and/or laboratory assessments as applicable to their malignancy.
- Has adequate performance status (PS): Eastern Co-operative Oncology Group (ECOG).
You likely can't join if
- Participants receiving cancer therapy at the time of enrollment.
- Any clinically significant disease or condition affecting a major organ system.
- Significant cardiovascular disease or electrocardiogram (ECG) abnormalities.
- Known Gilbert's disease.
- Has had a previous (within 2 years) or has a current malignancy other than the target cancer.
- Intermittent hypokalemia
See the full eligibility criteria
- 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
- Has evaluable or measurable tumor(s) in dose-escalation by standard radiological and/or laboratory assessments as applicable to their malignancy.
- Has adequate performance status (PS): Eastern Co-operative Oncology Group (ECOG).
- Is age ≥ 18 years.
- Has either tissue agnostic tumors and documented RAS mutations or with glioblastoma with or without mutation in RAS
- Participants receiving cancer therapy at the time of enrollment.
- Any clinically significant disease or condition affecting a major organ system.
- Significant cardiovascular disease or electrocardiogram (ECG) abnormalities.
- Known Gilbert's disease.
- Has had a previous (within 2 years) or has a current malignancy other than the target cancer.
- Intermittent hypokalemia
- Grade 1 or higher nausea, vomiting, diarrhea at baseline due to underlying disease
The study team makes the final eligibility decision.
Where it is enrolling
- Los Angeles, California, United States
- Denver, Colorado, United States
- Nashville, Tennessee, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Los Angeles, California, United States; Denver, Colorado, United States; Nashville, Tennessee, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.