Back to search results

A Study of RSC-1255 for Advanced Cancers with RAS Mutation

This study is testing a new medication called RSC-1255 for people with advanced solid cancers, including lung cancer, colon cancer, and glioblastoma (a type of brain tumor), especially if your cancer has a RAS mutation. You might be able to join if your current treatments aren't working, or you can't tolerate them. The study aims to find the safest and most effective dose of RSC-1255, given as a pill twice daily. Researchers will also look at how well RSC-1255 works alone or with another drug called hydroxychloroquine. The main goals are to figure out the highest safe dose and the recommended dose for future studies.

Study design
This is a Phase 1a/1b, open-label study, meaning you and your doctors will know you are receiving RSC-1255. It plans to enroll about 134 participants.
What's involved
You will take RSC-1255 orally twice daily, with each treatment cycle lasting 21 days. The study will involve regular check-ups to monitor your safety and how the drug is working.
Compensation
Not stated in the trial record.
Follow-up
The study aims to determine the maximum tolerated dose over approximately 30 months and the recommended dose for future studies over approximately 12 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04678648

A Trial of RSC-1255 for Treatment of Patients With Advanced Malignancies

Recruiting
PHASE1Ages 18+InterventionalTreatment
RasCal Therapeutics, Inc.
~134 participants
Updated 2026-06-23 on ClinicalTrials.gov
What's tested:RSC-1255 Dose EscalationRSC-1255 Dose Expansion

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum Tolerated Dose (MTD) for RSC-1255 as monotherapy
Measured over Approximately 30 months
+1 more outcome measured

Conditions

Advanced Malignant Solid Neoplasm
RAS Mutation
Lung Cancer
Colon Cancer
Glioblastoma
Pancreatic Cancer

Explore related trials

Colorectal CarcinomaGlioblastomaLung CarcinomaPancreatic CarcinomaSolid Neoplasm

Where it's being run

3 sites across 3 states
California1
Colorado1
Tennessee1

Study leadership

  • Michael Mann, MD · STUDY_DIRECTOR · RasCal Therapeutics, Inc.

Who to contact

Michael Mann, MD
[email protected]
310-498-7171
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

What this trial measures

  • Maximum Tolerated Dose (MTD) for RSC-1255 as monotherapyApproximately 30 months

    The number and type of dose-limiting toxicities (DLTs) as defined in the protocol that occur during the first 21 days of treatment and maximum grade of all treatment-related events using CTCAE V5.0 will be used to identify a safe and tolerable dose.

  • Recommended Phase 2 Dose (RP2D) for RSC-1255 as monotherapyApproximately 12 months

    The number and type of DLTs as defined in the protocol that occur during the first 21 days of treatment and maximum grade of all treatment-related adverse events using CTCAE 5.0 will be used to identify a safe and tolerable dose.