What side effects are associated with this type of intervention?

Common treatments for advanced solid tumors, such as chemotherapy, targeted therapy, and immunotherapy, often come with a range of side effects. Chemotherapy can cause fatigue, nausea, vomiting, hair loss, and increased risk of infections due to lowered blood cell counts. Targeted therapies, like PI3K inhibitors, may lead to hyperglycemia, decreased appetite, and diarrhea. Immunotherapies, such as checkpoint inhibitors, can result in immune-related adverse events including pneumonitis, colitis, hepatitis, and endocrinopathies. These side effects vary in severity and frequency, and managing them is crucial for maintaining patient quality of life during treatment.

What prior FDA approvals exist?

Several novel therapeutic agents have received FDA approval for the treatment of advanced solid tumors. For instance, pembrolizumab, an immune checkpoint inhibitor targeting PD-1, has shown efficacy in various cancers, including metastatic sarcomatoid renal cell carcinoma. Similarly, rucaparib, a PARP inhibitor, is approved for metastatic castration-resistant prostate cancer with homologous recombination repair gene mutations. Additionally, lutetium Lu 177 vipivotide tetraxetan, a radioligand therapy, has been approved for PSMA-positive metastatic castration-resistant prostate cancer. These treatments, like RSC-1255, represent advancements in targeting specific pathways and mechanisms in cancer therapy.

What other types of research exist?

Promising novel alternatives to RSC-1255 for cancer patients considering treatment in 2024 include: 1) Dabrafenib and Trametinib for tumors with BRAFV600E mutations, which have shown efficacy in various cancers including colorectal and biliary tract cancers. 2) Saracatinib (AZD0530), a selective Src kinase inhibitor, which has demonstrated antitumor activity in advanced solid tumors. 3) Pembrolizumab, an immune checkpoint inhibitor, which has shown clinical activity in advanced sarcomas and other solid tumors. 4) Cabozantinib, a tyrosine kinase inhibitor, which has been effective in advanced renal cell carcinoma and osteosarcoma. These agents represent promising options based on recent clinical trial data.

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RSC-1255 for Advanced Cancers

Phase 1

Recruiting

Research Sponsored by RasCal Therapeutics, Inc.

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:

Must not have

Any clinically significant disease or condition affecting a major organ system.

Participants receiving cancer therapy at the time of enrollment.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 30 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests RSC-1255, an oral drug designed to block proteins that help cancer cells grow. It targets adults with advanced solid tumors who have not responded to or cannot tolerate other treatments. The goal is to find a safe dose and see how well the drug works.

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any major organ system diseases.

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I am currently undergoing cancer treatment.

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I have heart disease or abnormal heart test results.

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I have been diagnosed with Gilbert's syndrome.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 30 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 30 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 30 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximum Tolerated Dose (MTD) for RSC-1255 as monotherapy

Recommended Phase 2 Dose (RP2D) for RSC-1255 as monotherapy

Secondary study objectives

Adverse event profile of RSC-1255

Overall Survival (OS)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: RSC-1255 TreatmentExperimental Treatment2 Interventions

Single Arm Study. All study participants receive RSC-1255.

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common cancer treatments include targeted therapies, immunotherapies, and traditional chemotherapies. Targeted therapies, like RSC-1255, work by specifically targeting molecular pathways that are essential for cancer cell survival and proliferation, thereby minimizing damage to normal cells. Immunotherapies enhance the body's immune system to recognize and destroy cancer cells, offering a more personalized approach. Traditional chemotherapies kill rapidly dividing cells but can affect both cancerous and healthy cells, leading to broader side effects. Understanding these mechanisms helps patients and doctors choose the most effective treatment with the least side effects, improving outcomes and quality of life.

Current trends and future directions in the genetic therapy of human neoplastic disease.Anti-colorectal cancer targets of resveratrol and biological molecular mechanism: Analyses of network pharmacology, human and experimental data.