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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Malignancy has progressed on standard therapy
Has pathologically confirmed advanced or metastatic malignancy characterized by one or more of the following:
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 24 months
Awards & highlights
Study Summary
This trial is testing a new drug, RSC-1255, for people with advanced solid tumors who can't tolerate other treatments or who have already failed other treatments. The study has two parts: first, they'll determine the best dose of the drug, and then they'll test its safety and effectiveness.
Who is the study for?
This trial is for adults with advanced solid tumors who have not responded to, or can't tolerate, standard treatments. It's open to those with certain types of cancer like lung and colon cancer, where the tumor can be measured by scans or tests. Participants must be over 18 and in stable condition as judged by ECOG performance status.Check my eligibility
What is being tested?
RSC-1255 is being tested in two phases: Phase 1a determines the safe dosage level while Phase 1b assesses its safety and effectiveness against various advanced cancers. The study aims to find out if RSC-1255 can help patients whose cancers haven't improved with other treatments.See study design
What are the potential side effects?
As this is an early-phase trial for a new drug, specific side effects are not yet fully known but may include typical reactions seen with cancer therapies such as fatigue, nausea, skin reactions, blood count changes leading to increased infection risk or bleeding tendencies.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has worsened despite treatment.
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My cancer is advanced or has spread to other parts of my body.
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My cancer has not responded to any treatment known to work.
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My cancer can be measured or evaluated using scans or tests.
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I am able to carry out daily activities with minimal assistance.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum Tolerated Dose (MTD) for RSC-1255 as monotherapy
Recommended Phase 2 Dose (RP2D) for RSC-1255 as monotherapy
Secondary outcome measures
Adverse event profile of RSC-1255
Overall Survival (OS)
Trial Design
1Treatment groups
Experimental Treatment
Group I: RSC-1255 TreatmentExperimental Treatment2 Interventions
Single Arm Study. All study participants receive RSC-1255.
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Who is running the clinical trial?
RasCal Therapeutics, Inc.Lead Sponsor
Robert Reder, MDStudy DirectorRasCal Therapeutics, Inc.
1 Previous Clinical Trials
122 Total Patients Enrolled
Media Library
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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