NCT04678648 A Trial of RSC-1255 for Treatment of Patients With Advanced Malignancies
| NCT ID | NCT04678648 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | RasCal Therapeutics, Inc. |
| Condition | Advanced Malignant Solid Neoplasm |
| Study Type | INTERVENTIONAL |
| Enrollment | 134 participants |
| Start Date | 2021-03-03 |
| Primary Completion | 2026-12-15 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 134 participants in total. It began in 2021-03-03 with a primary completion date of 2026-12-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Michael Mann, MD
STUDY DIRECTOR
RasCal Therapeutics, Inc.
Frequently Asked Questions
Who can join the NCT04678648 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Advanced Malignant Solid Neoplasm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04678648 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04678648 currently recruiting?
Yes, NCT04678648 is actively recruiting participants. Contact the research team at clinicaltrials@rascaltherapeutics.com for enrollment information.
Where is the NCT04678648 trial being conducted?
This trial is being conducted at Los Angeles, United States, Denver, United States, Nashville, United States.
Who is sponsoring the NCT04678648 clinical trial?
NCT04678648 is sponsored by RasCal Therapeutics, Inc.. The principal investigator is Michael Mann, MD at RasCal Therapeutics, Inc.. The trial plans to enroll 134 participants.