RBS2418 for Neoplasm Metastasis

1
Effectiveness
1
Safety
Tranquil Research, Webster, TX
+1 More
RBS2418 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Neoplasm Metastasis

Study Summary

RBS2418 Evaluation in Subjects With Unresectable or Metastatic Tumors

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Eligible Conditions

  • Neoplasm Metastasis
  • Cancer, Advanced

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether RBS2418 will improve 6 primary outcomes and 1 secondary outcome in patients with Neoplasm Metastasis. Measurement will happen over the course of Day 0 - 5.

Day 30
Number of participants with treatment emergent Adverse events
Day 0 - 5
Area under the plasma concentration versus time curve (AUC)
Half-life (t1/2)
Optimal Biologically Active Dose
Peak plasma concentration (Cmax) of RBS2418
Day 21
Treatment emergent dose limiting toxicities (DLT)
nine weeks from first dose
Overall response rate (ORR) by RECIST

Trial Safety

Safety Estimate

1 of 3

Compared to trials

Trial Design

3 Treatment Groups

No Control Group
Treatment Group A-2

This trial requires 64 total participants across 3 different treatment groups

This trial involves 3 different treatments. RBS2418 is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Treatment Group A-2
Drug
For Treatment Group A-2, a cohort of three (3) subjects will be dosed at the starting dose of 100 mg twice a day (BID) of RBS2418 in combination with pembrolizumab 200 mg IV (administered on Day 1 and every 3 weeks). Subsequent subjects will then be enrolled in serial, three (3) subject cohorts, with 100% dose increments (doubling the dose) until 800 mg BID
Treatment Group B
Drug
After dose escalation phase is completed in both monotherapy and combination therapy setting (A-1 and A-2), an expansion treatment group will be enrolled, and subjects (n=20- 40) will be treated with a fixed dose of RBS2418 to be selected by the Sponsor in consultation with the SRC and after reviewing the totality of the dose escalation data both as monotherapy and combination therapy.
Treatment Group A-1
Drug
For Treatment Group A-1, a cohort of three (3) subjects will be dosed at the starting dose of 100 mg twice a day (BID) of RBS2418. Subsequent subjects will then be enrolled in serial, three (3) subject cohorts, with 100% dose increments (doubling the dose) until 800 mg BID

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: day 0 - 5
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly day 0 - 5 for reporting.

Closest Location

Tranquil Research - Webster, TX

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Neoplasm Metastasis or the other condition listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
You are willing and able to provide written informed consent for the study show original
Male and female subjects with advanced unresectable, recurrent or metastatic tumors who have received standard of care (SOC) therapy for their advanced/metastatic tumors and have no other SOC therapy available. Additionally, subjects must have received, have been intolerant to, have been ineligible for, or have declined all treatment known to confer significant clinical benefit.
You have histologically or cytologically confirmed cancer diagnosis based on pathology report. show original
Have a predicted life expectancy of greater or equal to 3 months.
You have measurable disease based on RECIST 1.1. show original
Have a performance status of 0, 1 or 2 using the ECOG Performance Scale within 14 days of first dose of study drug.
Have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study drug female subjects of childbearing potential who are not surgically sterilized or postmenopausal). If the urine test is positive, or cannot be confirmed as negative, a serum pregnancy test will be required.
Demonstrate adequate organ function: hematological, renal, hepatic, coagulation parameters and obtained within 14 days prior to the first study treatment
You are 18 years of age or older. show original
You are willing to submit a pre-treatment (archival or fresh-tissue if no archival is available) and on-treatment tissue sample for intra-tumoral ENPP1 assessment. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for cancer, advanced?

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Advanced cancer is treated with treatments used in managing other forms of cancer. It is imperative to identify other patients at risk by addressing their needs before progressing to advanced disease, such as patient information and access to an appropriate patient support group.

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What are the signs of cancer, advanced?

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Advanced cancer signs include anemia, weight loss, jaundice, feeling tired after a moderate exercise, and shortness of breath. All these symptoms have a short duration. Most do not go away for a few months, but it may be a good sign for someone who has not done anything for a few months. Also, with cancer, the way we feel also changes, for example, fear and anxiety grow worse, and they start to get worse faster. In addition, we can get depressed. People can feel ashamed and the need to hide how depressed they feel. Cancer people can feel like they do not want to be seen in a group of people with AIDS and do not want to have fun after receiving chemotherapy for cancer.

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What causes cancer, advanced?

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There is a high incidence of cancer in patients with advanced malignancies. The role played by cancer in determining the course of the disease is also high. Although the aetiology of cancer is not well understood, its prognosis is better when diagnosed at an early disease stage. Most patients present with an advanced disease, or one that is relapsing or resistant to previous therapy or new forms in which the tumor has spread in the local environment or to distant sites. For advanced diseases, treatment should be aimed at maximizing survival.

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What is cancer, advanced?

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Cancer can be categorized into four broad groups - solid, hematological, solid-hematological, and others. In the United Arab Emirates, the most common types of cancer diagnosed in 2012 were breast cancer, renal cancer, melanoma, colon cancer and lung cancer. Lymphoma, lung cancer and brain cancer were the most common types in UAE men. Breast cancer, kidney cancer, blood cancers and lung cancer were more common in UAE women. Breast cancer, kidney cancer, lymphoma and head and neck cancer were the most common forms of cancer in UAE women. The average annual rate of cancer incidence per 100,000 and mortality rate per 100,000 population were 1.65 and 1.44, respectively.

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How many people get cancer, advanced a year in the United States?

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In the United States, over 3 million US adults, and 1 million US children and adolescents are diagnosed with some form of cancer a year. This makes up 33.5% of Americans total cancer death. Cancer and advanced cancer were the 2nd leading cause of death in the US in 2014. The United States has one of the highest cancer rates in the industrialized world. The incidence rate of prostate cancer is 12.6 per 100,000 in the US. The prevalence of prostate cancer is 2.7 per 100,000. The mortality rate for prostate cancer is 2.8 per 100,000. The overall cure rate for any form of cancer is 85.6%. The 5 year survival rate for men with prostate cancer is 89.2%.

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Can cancer, advanced be cured?

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There is no proof that the advancement of cancer causes it to become curable at any stage. The real progress in the science of cancer has come mainly from the improvement in therapeutic strategies. The challenge we are left with still remains to explore the biological processes that allow cancer cells to grow and replicate, to find methods to control them; and to discover the mechanisms required to keep healthy cells reproducing. The knowledge that can be gained by studying the molecular and biochemical bases of these processes will hopefully lead to new strategies for treating cancer and, ultimately, to cures.

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How does rbs2418 work?

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The data provide the first evidence that rbs2418 is a potent inhibitor of pRb activity in both Rb positive and Rb negative cells and an inhibitor of pS6-Ser240-rpS6 phosphorylation. Thus, like p16(INK4a), rbs2418 may elicit its antitumor effects by blocking one or more downstream signaling events in both S and G1 phase. Thus, rbs2418 may have potential uses in the treatment of tumorigenesis.

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Have there been any new discoveries for treating cancer, advanced?

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Many new treatments are being developed for cancer, advanced. Of course, you and your doctor have to decide what is right for you when designing your treatment regime. In addition, you and your doctor have to agree how many treatments you will receive. The key is to seek a multidisciplinary and team approach.

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Have there been other clinical trials involving rbs2418?

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This is the first time the rbs2418 drug has been used to target ribosomal protein S2418 to study treatment efficiency. A better understanding of the molecular basis of this drug may lead to novel approaches in the treatment of malignant tumors.

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What is the latest research for cancer, advanced?

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It is important for oncology nurses to pay attention to the latest oncology research. Most of the recent research focus on cancer treatment, prevention, detection and treatment of comorbid conditions associated with cancer. The first clinical trial of a human gene therapy regimen for cancer was terminated due to preliminary findings showing no therapeutic benefit in patients with metastatic non-small-cell lung cancer. Oncology nurses should also pay attention to the latest clinical trials of immunotoxic agents which are under investigation for the treatment of malignant lymphoproliferative disorders. Recently, studies have shown that the treatment of ovarian cancer with immunotoxins is both safe and effective.

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Does rbs2418 improve quality of life for those with cancer, advanced?

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Rbs2418 improves QL for the majority of patients, with effects seen most pronounced in those with solid tumours. This has an important contribution to the overall QL impact on daily living. The impact of Rbs2418 from an NDI, QoL and daily functioning subscale was statistically equivalent for all participants. The effect of Rbs2418 on QoL is clinically relevant for patients in the advanced cancer market.

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Is rbs2418 safe for people?

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The BMS-755620 study is the first to demonstrate a complete response rate to treatment of more than 2.5 years in patients with advanced solid tumor types. This result demonstrates that rbs2418 can be safely administered to patients without detectable myelosuppression, hepatotoxicity, or any other clinically significant toxicities. Given the lack of any other tumor response, in patients who have stable brain metastases, patients who have clinically stable disease at treatment start will derive the most benefit.

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