Recruiting nowPhase 1
What this trial is trying to do
The trial is testing RSC-1255 in people with advanced solid tumours whose disease has progressed after, or who cannot tolerate, standard treatments. The researchers are first working out the highest dose that can be given safely, then describing the drug’s safety and any signs of anti-tumour activity.
The idea is that RSC-1255 could offer another treatment option when therapies known to help are no longer suitable, but this trial is mainly measuring safety and the maximum tolerated dose rather than proving longer survival or longer control of the cancer.
Worth knowing: This is a small, non-randomised Phase 1 trial with no comparison group, so it is designed primarily to assess safety and dosing, not to establish treatment benefit.
Written from the trial's own registry entry to explain what the researchers are testing and why. Nothing here is a result — this trial has not reported one — and it is not a view on whether the treatment works or on whether it would suit you.
| Registry number | NCT04678648 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 1 |
| Design | open label |
| Taking part | 134 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | RasCal Therapeutics, Inc. |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug RSC-1255 Dose Escalation
- Drug RSC-1255 Dose Expansion
What it is measuring
Maximum Tolerated Dose (MTD) for RSC-1255 as monotherapy
This is the trial's main question — the one it is designed and sized to answer. Anything else it reports is a secondary finding, and secondary findings are far more likely to be chance.
Phase 1. Tests safety and dose in a small group. Some people do benefit, but that is not what the trial is designed to find out.
How the researchers describe it
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.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Metastatic
- Colon
- Already treated
Read automatically from the criteria below, to make the list searchable. It is a summary of what the text mentions, not a decision about whether you qualify — and where the two disagree, the criteria are right and this is wrong.
Who the trial is looking for
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
This is an extract. Whether you qualify is decided by the trial team against the full criteria, not by reading this page. Read the full eligibility criteria
Where it is running
Running at 3 sites. Listed in: United States.
Individual hospitals, and whether each is currently open, are listed on the registry record. Sites open and close throughout a trial.
Worth asking your oncology team
Being listed here is not a recommendation, and no one page can tell you whether a trial is right for you. These are the questions it raises.
- Is this trial open at a hospital I could realistically travel to?
- Given my stage, my previous treatment and my tumour's molecular profile, would I be eligible?
- What would I be giving up by joining — is the comparison arm the treatment I would otherwise be having?
- What is already known about the safety of what is being tested?
The source
Registry record NCT04678648, registered by RasCal Therapeutics, Inc. on ClinicalTrials.gov, a public database run by the US National Library of Medicine. The details on this page come from that record and are only ever as current as the sponsor has kept it.
This is a listing of a registered clinical trial, reproduced for information. It is not a recommendation, this site has no connection to the trial or its sponsor, and being listed here says nothing about whether the treatment works. Talk to your own oncology team before pursuing any trial.
This article summarises published research for general information. It is not medical advice, and it is not a substitute for a conversation with your own oncology team, who know your case. Do not start, stop, or change any treatment or supplement on the basis of what you read here.