DSP-0509 for Cancer

Phase-Based Estimates
1
Effectiveness
1
Safety
University of North Carolina at Chapel Hill, Chapel Hill, NC
DSP-0509 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Cancer

Study Summary

This study is evaluating whether a combination of two drugs may help treat patients with advanced solid tumors.

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Treatment Effectiveness

Study Objectives

This trial is evaluating whether DSP-0509 will improve 5 primary outcomes, 10 secondary outcomes, and 5 other outcomes in patients with Cancer. Measurement will happen over the course of 4 weeks.

12 months
Evaluate the PFS rate as a potential evaluation of treatment benefit of DSP-0509 administered with Pembrolizumab. Combination Arm - Part C (Dose Expansion)
Evaluate the effect of DSP-0509 on cardiac parameters by assessing continuous 25-hour ECG recordings.
Exploratory pharmacodynamic evaluation as potential biomarkers capable of predicting the clinical efficacy or toxicity
Exploratory pharmacodynamic evaluation as potential efficacy-related immune response biomarkers.
PFS by iRECIST
Progression free survival (PFS) by RECIST
4 weeks
Determination of the Recommended Phase 2 Dose (RP2D) of DSP-0509 for the Dose Expansion part by assessing dose-limiting toxicities (DLTs)
Determine the MTD of DSP-0509 when given in combination pembrolizumab - by assessing DLTs.
Determine the maximum tolerated dose (MTD) of DSP-0509 by assessing dose-limiting toxicities (DLTs)
Identify a RP2D of DSP-0509 when given in combination with pembrolizumab - by assessing DLTs
To evaluate the preliminary antitumor activity of DSP-0509 in combination with pembrolizumab in patients with HNSCC who have shown primary or acquired resistance to ICIs - Combination arm - Part C (Dose Expansion)
6 months
DoR by iRECIST
Duration of response (DoR) by RECIST
ORR by immune RECIST (iRECIST)
Objective response rate (ORR) by RECIST
8 weeks
Evaluate change in cytokine levels induced by DSP-0509 in combination with pembrolizumab.
Evaluate pharmacokinetics (PK) for combo agents DSP-0509 and pembrolizumab by assessing plasma concentration.
Evaluate pharmacokinetics (PK) for single agent DSP-0509 by assessing plasma concentration.
Evaluate single agent DSP-0509-induced changes in cytokine levels.
Identification of potential metabolites of DSP-0509 in plasma and possibly in urine.

Trial Safety

Trial Design

3 Treatment Groups

No Control Group
Monotherapy Arm - Part A

This trial requires 100 total participants across 3 different treatment groups

This trial involves 3 different treatments. DSP-0509 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 & 2 and have already been tested with other people.

Monotherapy Arm - Part A
Drug
Dose Escalation Drug DSP-0509
Combination arm - Part C
Drug
Dose Expansion, Drug DSP-0509, Pembrolizumab
Combination arm - Part B
Drug
Dose Escalation Drug DSP-0509, Pembrolizumab

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 12 months for reporting.

Closest Location

University of North Carolina at Chapel Hill - Chapel Hill, NC

Eligibility Criteria

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

Mark “yes” if the following statements are true for you:
Combination Part B (Dose Escalation)- advanced solid tumors that are (a) metastatic or unresectable and recurrent and/or refractory to available therapy; (b) a condition for which pembrolizumab is an approved treatment: and (c) in patients who either have shown primary or acquired resistance to immune checkpoint inhibitors (ICIs)
Combination Arm C (Dose Expansion), Phase 2 - Advanced HNSCC tumors of the oropharynx, oral cavity, hypopharynx, larynx, lip, or sinus that are (a) metastatic or unresectable, and recurrent and/or refractory to available therapy, (b) in patients who have been treated with pembrolizumab or other PD-1 or PD-L1 inhibitors in monotherapy, and (c) who have subsequently shown primary or acquired resistance to ICIs.
You must be 18 years of age or older.\n show original
You have a history of any prior therapy or procedures for any medical condition. show original
You have at least 1 measurable lesion by computed tomography or magnetic resonance imaging per RECIST v1.1. show original
You have a life expectancy of 3 to 6 months.\n show original
6. Female patients of childbearing age and women < 12 months since the onset of menopause, except those who have been surgically sterilized (tubal ligation) or whose sexual partner(s) is surgically sterilized (vasectomy), must agree to use acceptable contraceptive methods for the duration of the study and for 9 months after the date of their last DSP-0509 infusion. If employing contraception, 2 of the following precautions must be used: birth control pill, vaginal diaphragm, intrauterine system or device, condom or vaginal spermicide. Female patients who are postmenopausal are defined as those with an absence of menses for ≥ 12 consecutive months. Male patients must be surgically sterilized (vasectomy) or their female sexual partner(s) must be surgically sterilized (tubal ligation) to avoid using contraception. If they do not meet this criterion, then male patients or must agree to use a condom as well as one of the acceptable contraceptive methods listed above with their female partner(s) who meets the criteria of either being of childbearing age or is < 12 months since the onset of menopause. Male patients and their female partner(s) must agree to use acceptable contraception methods for the duration of time the male patient is on the study and for 9 months after the date of his last DSP 0509 infusion.
You are a female of childbearing potential who has a negative serum pregnancy test. show original
You have a solid tumor that is metastatic or unresectable and recurrent and/or refractory to available therapy. show original
You have a histologically or cytologically confirmed advanced solid tumor that meets the following additional specifications. 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 the signs of cancer?

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Cancer can appear on the eye in many ways: blemishes, warts, growths, lesions or tumours. Other signs such as an enlarged lymph node can show cancer, but this is usually an incidental finding. However, some malignancies can cause swelling of the lymph nodes. Other signs may include bleeding, or skin change such as a rash or itching. Pain on the skin is also an important symptom of a cancer or infection, and can be found in many areas, such as a wound or painful mass behind the knees. When a cancer is in situ, swelling outside of the affected area can be another sign. The tumour can also form a lump, known as an oedema, which can be hard.

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What causes cancer?

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Cancer can be caused by a change in the DNA's structure (e.g. mutations or epigenetic changes) or the body's response to this change (e.g. mutation is not sensed, or the protein produced by the gene fails to help the cell or alter the activity of signaling pathways that normally control the cell).\n\nMany medications are marketed for the treatment of psychiatric and physical conditions, or as a cure for many common diseases. Medications may be grouped by mechanism. Medication is considered to have therapeutic effect if it influences disease or restores or maintains health. A number of medicines have demonstrated anti-cancer properties.

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What are common treatments for cancer?

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There is growing concern about cancer treatment and how it impacts patients' quality of life. The most frequently used treatments include surgery, chemotherapy, radiotherapy, targeted therapy, or a combination of these. Most patients receive chemotherapy in all stages of cancer and about 1 in 5 patients receive radiation in all stages of cancer. Surgery is usually considered for non–surgical patients and radiotherapy is usually not routinely used until after surgery. Chemotherapy is usually used with curative intent, and in most localized cases of cancer. A personalized approach is usually the most appropriate approach with the ultimate aim for improving the lives of patients.

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Can cancer be cured?

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Even though cancer seems to be incurable, in every disease, especially in the case of cancer, there is a chance of cure. The main clue is to keep it in mind that no disease can never be cured since the disease is the result of genetic defects. Only a set of healthy living habits can make cancer disappear.

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

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About 200,000 people die annually of cancer in the United States. Most of those deaths are related to breast, colon, and lung cancer, combined with leukemia and cervical cancer. In addition to cancer, 25,000 Americans die of all other causes of death each year. More than 7,500 of these deaths are attributable to cigarette smoking. The incidence of throat cancer, colorectal cancer, and head and neck cancer is increasing in the United States. This pattern may be due to increasing tobacco use by the general population or the fact that these cancers are often associated with chronic viral infections. Breast cancer has been linked with estrogen. Colon cancer is linked with dietary fat and red meat. Lung cancer is linked with smoking and radon.

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What is cancer?

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Cancer is a group of diseases in which abnormal cells grow in an uncontrolled manner and can invade or spread to other parts of the body. It is typically a disease that worsens over time, especially if left untreated. The most common forms of cancer are skin cancer, breast cancer, colon cancer, stomach cancer, lung cancer, and bowel cancer, which are all prevalent in industrialized countries. The most common types of cancer are liver cancer, prostate cancer, brain cancers, and throat cancers, which are also prevalent in industrialized countries. Overall, cancers cause around 12 percent of all deaths worldwide in 2006.

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How serious can cancer be?

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The disease is more dangerous to life than any other disease. But, the severity of life threatening symptom in the body determines the severity of the disease. Symptoms like fatigue, weight loss, loss of appetite, diarrhea, constipation, weakness, lack of physical energy, shortness of breath, breathing difficulty and heart troubles is not alarming for life threatening, yet not the death rate of cancer cases is not alarming either\n

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What is the latest research for cancer?

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It has been argued that we have more than enough cancer information, especially from the perspective of the general public, but the research needs to move forward as well. We can and need more cancer information as well as more cancer patient and family support and better access to cancer care. How is access to affordable cancer care affected by medical decisions?

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What are the latest developments in dsp-0509 for therapeutic use?

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This promising treatment may be useful in the treatment of metastatic squamous cell carcinoma of the head and neck and/or recurrent squamous cell skin carcinoma after skin field radiation therapy. This compound appears to be well tolerated.

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Has dsp-0509 proven to be more effective than a placebo?

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This new dsp-0509 (cis and trans amide) showed no statistical difference compared to a placebo or sham. No significant decrease in the number or size of the tumors was found on necropsy in rats with an experimental osteosarcoma, a type of cancer which affects humans, at a rate that is more than six times faster than humans. The drugs may act as cancer chemotherapy drugs at a time point beyond tumor eradication of the first or second tumors but may not act at all when the tumor is completely removed from the patient. Dsp-0509 is not useful or useful at all in cancer therapy.

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What is the primary cause of cancer?

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Cancer is a multifactorial disease. Causes are related to external or internal environmental conditions, genetic susceptibility and to diet. Cancer develops as a result of complex interplay between external, internal and genetic factors. Many environmental factors increase the risk of developing cancer. The genetic predisposition, epigenetic factors and diet are considered to be major determinants of the development of cancer. The environmental contribution to cancer appears to be substantial. A combination of multiple risk factors such as smoking, alcohol consumption and diet, may be more important in the development of cancer than individual factors.

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What are the common side effects of dsp-0509?

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DSP-0509 administered as a single i.v. bolus dose (1000 µg x kg(-1)) to healthy volunteers resulted in dose-related responses, including fatigue, nausea and vomiting, sweating and headache; these symptoms subsided within the first 3 to 4 hours post-administration. When the drug was administered as a continuous i.v. infusion to [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) patients (400 µg x min(-1)), the infusion system delivered constant plasma concentrations and no other side effects were reported. The side effects were dose-related and no systemic effect was observed. It is recommended that further clinical studies in advanced cancer be conducted using dsp-0509 as a single i.v.

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