RP-6306 for Solid Tumors, Advanced Solid Tumors

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Participating Site #4001, Copenhagen, Denmark
Solid Tumors, Advanced Solid Tumors+1 More
RP-6306 - Drug
Eligibility
Any Age
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug may help treat cancer.

See full description

Eligible Conditions

  • Solid Tumors, Advanced Solid Tumors

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether RP-6306 will improve 4 primary outcomes and 8 secondary outcomes in patients with Solid Tumors, Advanced Solid Tumors. Measurement will happen over the course of Up to 90 days after last administration of study intervention.

Year 1
To assess preliminary anti-tumor activity of RP-6306 monotherapy
To assess the percent of patients with a response to RP-6306 and RP-3500 per RECIST v1.1 criteria.
To assess the percent of patients with a response to RP-6306 monotherapy per RECIST v1.1 criteria.
Day 90
Safety and Tolerability of RP-6306 in combination with RP-3500 in patients with advanced solid tumors as assessed by NCI CTCAE v5.0
Safety and Tolerability of RP-6306 in patients with advanced solid tumors as assessed by NCI CTCAE v5.0
To define the MTD of RP-6306 in combination with RP-3500, and determine a recommended Phase 2 dose (RP2D) and preferred schedule
To define the MTD of RP-6306 monotherapy, and determine a recommended Phase 2 dose (RP2D) and preferred schedule
Month 3
To assess the correlation between RP-6306 and RP-3500 dose (mg) and degree of gamma-H2AX induction by immunohistochemistry.
To assess the correlation between RP-6306 dose (mg) and degree of inhibition of phospho-CDK1 signal by immunohistochemistry.
To assess the relationship between pharmacodynamic biomarkers and PK of RP-6306 at different dose levels and/or schedules
Year 1
To assess PK parameters of RP-6306 monotherapy in fasted and fed states
To assess the plasma concentrations of RP-6306 monotherapy in the fasted and fed states.

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Phase 1: RP-6306 in combination with RP-3500, Dose Escalation Study
1 of 2
Phase 1: RP-6306 Single-Agent, Dose Escalation and Food-effect Study
1 of 2
Experimental Treatment

This trial requires 120 total participants across 2 different treatment groups

This trial involves 2 different treatments. RP-6306 is the primary treatment being studied. Participants will be divided into 2 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.

Phase 1: RP-6306 in combination with RP-3500, Dose Escalation StudyPatients receive RP-6306 with RP-3500 orally until disease progression, unacceptable toxicity, or investigator/patient decision. Dose escalation will proceed until a maximum tolerated dose is identified.
Phase 1: RP-6306 Single-Agent, Dose Escalation and Food-effect Study
Drug
Patients receive RP-6306 orally until disease progression, unacceptable toxicity, or investigator/patient decision. Dose escalation will proceed until a maximum tolerated dose is identified.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, an average of 1 year
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly through study completion, an average of 1 year for reporting.

Closest Location

Participating Site # 1001 - Houston, TX

Eligibility Criteria

This trial is for patients born any sex of any age. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Male or female and ≥12 years-of-age at the time of informed consent.
Lansky performance status ≥50% for patients ≤16 years of age, or ECOG score of 0, 1, or 2 for patients >16 years of age.
Locally advanced or metastatic resistant or refractory solid tumors.
Patients <18 years of age must weigh at least 40 kg.
Submission of available tumor tissue at screening or willingness to have a biopsy performed if safe and feasible
Next generation sequencing (NGS) report obtained in a CLIA-certified or equivalent laboratory demonstrating eligible tumor biomarker.
Measurable disease as per RECIST v1.1.
Ability to swallow and retain oral medications.
Acceptable hematologic and organ function at screening.
Negative pregnancy test (serum) for women of childbearing potential (WOCBP) at Screening.

Patient Q&A Section

Can cancer be cured?

"It is not possible to cure cancer, and the question 'Can cancer be cured? can be answered in different ways, because cure is not a precise scientific term. The answer to 'can' is no. But how can we find the cure? This answer is, 'if I know exactly what we're looking for, we can then use the cure to target our search and find the cure: in other words, the disease is a target (the target of the cure) rather than the cure: a target that is located on-line to a cure, in the form of the cure itself, which exists in the world rather than on the mind of the patients." - Anonymous Online Contributor

Unverified Answer

What are the signs of cancer?

"Symptoms of cancer can range from fatigue and loss of appetite, to persistent coughing, to shortness of breath, to vomiting, to unexplained weight loss, loss of appetite, fatigue and shortness of breath." - Anonymous Online Contributor

Unverified Answer

What are common treatments for cancer?

"The common treatments for cancer are surgery, chemo/radiotherapy and biologic therapies, while for some specific cancers there are therapies unique to those conditions - namely, palliative care for patients with advanced cancer, who often suffer from pain, and immunotherapy to enhance immune responses in patients with inoperable cancer. Finally, many patients are treated with a variety of complementary medicines to manage their cancer. Commonly used supplementary treatments include herbal medicine (including dietary supplements), acupuncture, massage, reflexology, nutrition, herbal remedies and homeopathy. The most popular cancer patients have previously or currently undertaken conventional treatments and are now also trying complementary therapies to prolong life and delay or reduce the severity of their disease." - Anonymous Online Contributor

Unverified Answer

What causes cancer?

"Most cancer cases are thought to arise from either mutational errors during DNA replication or errors after DNA repair. Mutations are most common in tissues which have limited opportunity for cell division, such as skin or lung epithelium. Most errors are usually harmless, but cancers can sometimes arise or worsen when they become malignant. Mutational errors and mutations can happen spontaneously, but they may also develop under the influence of environmental toxicants. The most common cancers with significant environmental causation include lung, breast, and prostate. Epigenetic changes of tumour suppressor genes may also have a role. In many cases, a combination of genetics and environmental factors likely combine to produce many different types of cancer." - Anonymous Online Contributor

Unverified Answer

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

"The incidence of cancer is about 2.3 million a year within the United States and approximately 600,000 die of the disease annually. A full understanding of cancer incidence, prevention, and treatment should be the aim of clinical oncologists." - Anonymous Online Contributor

Unverified Answer

What is cancer?

"Cancer is a disease in which abnormal cells grow out of control, invade normal tissue, and eventually destroy cells and tissues. Every cancer is unique, affecting a specific organ to a specific extent. Cancer is diagnosed based on symptoms and is confirmed by biopsy. The term "cancer" includes many types of cancer, and the label "cancer" is not a medical diagnosis. To provide the specific information and treatment needed, physicians rely on many factors and on the results of imaging techniques such as computed tomography (CT), positron emission tomography (PET), and magnetic resonance imaging (MRI)." - Anonymous Online Contributor

Unverified Answer

What does rp-6306 usually treat?

"The majority of lung tumor (non-small cell lung cancer) patients treated to date using rp-6306, a prolyl hydroxylase inhibitor, have had a durable response. Tumor progression that is not chemoresistant is sometimes observed and is best treated using agents, such as irinotecan, that are known to affect hypoxia (low oxygen levels) in tumors. A further chemotherapeutic and anti-angiogenic agent may have to be added to help overcome tumor progression. However, the use of drugs specifically targeting the proline prolyl hydroxylase pathway for lung cancer is not likely to yield lasting cures." - Anonymous Online Contributor

Unverified Answer

What is rp-6306?

"Rp-6306 inhibited the growth of xenografted MCF-7 tumors in nude mice when given at 1.0 mg/kg/or less. Rp-6306 treatment decreased the number of MCF-7 cells in the bone marrow and decreased the level of serum IGF-I. Rp-6306 decreased the levels of STAT3 phosphorylation, increased the cell death fraction, and increased the level of p53 in MCF-7 cells. We hypothesize that Rp-6306 inhibited cellular processes by targeting the phosphorylation of STAT3 and its downstream transcription factors, and therefore inhibits the growth of MCF-7 cells." - Anonymous Online Contributor

Unverified Answer

Has rp-6306 proven to be more effective than a placebo?

"Although a clear trend toward increased survival was seen in these patients, this randomized study could not confirm the hypothesis that Rp-6306 is an effective treatment for mBC. Due to the low number of patients in this study, we are unable to draw conclusions concerning the safety or efficacy of this agent." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in rp-6306 for therapeutic use?

"The data show promising results in this preclinical model of [pancreatic cancer](https://www.withpower.com/clinical-trials/pancreatic-cancer) and may help guide future clinical investigations with rp-6306 for the treatment of patients with pancreatic cancer. Noble prize winner Dr. Otto H Warburg Cancer Research Center, New York University School of Medicine, M.D.\n" - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for cancer?

"Only persons willing to be involved should be referred to cancer clinical trials. The trial should also be tailored to the preferences of the person and the available treatment opportunities." - Anonymous Online Contributor

Unverified Answer

Does rp-6306 improve quality of life for those with cancer?

"Findings from a recent study for the first group of the study were promising for clinical practice and may have important implications for health services. The second group was excluded. Rp-6306 is safe and well tolerated in patients with advanced cancer. Further research is required to establish the role of rp-6306 in the palliative care of a wider group of patients." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
See if you qualify for this trial
Get access to this novel treatment for Solid Tumors, Advanced Solid Tumors by sharing your contact details with the study coordinator.