IDE397 for Cancer

Phase-Based Estimates
1
Effectiveness
1
Safety
City of Hope, Duarte, CA
Cancer+1 More
IDE397 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Cancer

Study Summary

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

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Eligible Conditions

  • Cancer
  • Neoplasms
  • Tumors, Solid

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether IDE397 will improve 2 primary outcomes and 3 secondary outcomes in patients with Cancer. Measurement will happen over the course of 21 days following the first dose of IDE397.

Day 21
Dose-limiting Toxicities (DLTs) of IDE397
Approximately 2 years
Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of IDE397
Pharmacodynamic effect of IDE397
Plasma Pharmacokinetics of IDE397 and metabolite
Preliminary anti-tumor activity

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Control
Dose Escalation Monotherapy

This trial requires 40 total participants across 2 different treatment groups

This trial involves 2 different treatments. IDE397 is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Dose Escalation Monotherapy
Drug
IDE397 dosed orally, once daily (QD) for each 21-day cycle
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: approximately 2 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly approximately 2 years for reporting.

Closest Location

City of Hope - Duarte, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Cancer or the other condition listed above. There are 8 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Advanced or metastatic solid tumor that has progressed on at least one prior line of treatment or is intolerant to additional effective standard therapy
Have evidence of homozygous loss of MTAP or MTAP deletion at the DNA or protein level in the participant's tumor tissue
Measurable disease
ECOG performance status <= 1 or 2
Participant must be at least 18 years of age
Adequate organ function
Able to swallow and retain orally administered study treatment
Able to comply with contraceptive/barrier requirements

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 causes cancer?

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Cancer is a complex multi-factorial disease, and can be broadly explained as the result of many separate alterations, including changes in genetic material, changes in normal cellular processes, and changes in the microenvironment. If cancer can be better understood as a result of multi-faceted change, there are numerous methods for its prevention, detection, and treatment.

Unverified Answer

What are common treatments for cancer?

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The list of common cancers and treatment methods is extremely long and will be divided into two main categories according to the life stages. First of all this will help us to develop a plan if one encounters a disease that a patient is being treated for or has or will have. We are no more limited for treatments, but the disease and the patient will dictate which method we need to use in order to cure them. Now for the first group: We'll start with treatments for different stages of cancer by dividing them into specific types for children, and then generalizing them for the other stages. So for example, treatments for lung, colon, or other cancers can be generalized and applied to other stages of cancer.

Unverified Answer

What is cancer?

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The word cancer includes a number of diverse genetic conditions that are all associated with the abnormal proliferation of mutated cells. This leads to the formation of malignant tumors: mass lesions formed by the malignant cells. As with most neoplastic diseases, an initiation event leads to cancer. This initiates a series of changes leading to a malignant growth. These malignant conditions may be initiated by cellular mutation, by hormonal influences, or by oncogenic viral mutations.\n

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Can cancer be cured?

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Current medical research has identified a broad range of disease types in which cancer can be cured, but most people will die of unrelated causes, primarily old age or non-cancer related diseases. We have found that many cancer cures work in a very specific way, e.g. inducing prolonged remission and not affecting the original disease. Thus, most cancer cures do more harm than good when used on standard cancer treatments. Furthermore, some cures have been shown to be harmful in an unrelated way; for example, many chemotherapies can produce a state of remission that is fatal for the patient, because any further cancer that should arise will be in the presence of the suppressed cancer that has no immunity to the new cancerous cell.

Unverified Answer

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

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The American Cancer Society estimates 807,000 new diagnoses of cancer will be made in 2022. In the United States, the most common types of cancer are breast cancer, non-small cell lung cancer, and colorectal cancer, and leukemia is the most common type of bone cancer. The American Cancer Society also estimates there will be over 790,000 new cases of throat cancer, 745,000 new cases of anal cancer, and more than 600,000 new cases of cancer of the brain and central nervous system, the second tier type.

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How serious can cancer be?

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There is little difference between how severe cancer might be for a male or female. The only major variable is where the disease struck. In my case, an intestinal tumor is more deadly than an ovarian cancer. All of our patients were diagnosed and treated within a week of their first symptoms, but the mean time from diagnosis of ovarian cancer to the start of treatment of my cancer was eight weeks, compared to about a week for a tumor to strike in my colon. In all the cases, the cancer was treated surgically and my cancer recovered very well.

Unverified Answer

What are the latest developments in ide397 for therapeutic use?

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Data from a recent study confirms that Ide397 has proven efficacy in the treatment of patients with advanced esophageal cancer using it in combination with concurrent therapy.

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Is ide397 typically used in combination with any other treatments?

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Although ide397 effectively treats most tumors in a clinical model, the activity of ide397 alone is moderate and depends in large part on the tumor type. This may be partially due to the fact that multiple pathways regulate cell division, including cell cycle progression and, to a lesser extent, apoptosis. It is unlikely that any anti-mitotic agents will prove as useful as ide397 in a clinical setting because they are too narrowly targeted, inhibiting one of the numerous signaling pathways involved in mitogenesis even though they may be effective in the clinic.

Unverified Answer

What are the common side effects of ide397?

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Our patient survey found that the side effects of ide397 were rare and no patient had to stop the drug due to side effects. A large majority of patients reported no side effects to ide397 by the end of the study. We believe that the side effects of ide397 are rare. This drug has shown to be well-tolerated in preclinical trials, and was well-tolerated in our study as well. There were 6.8% of patients in our study who reported dizziness, and 2.6% of patients reported dyspepsia, but these were usually mild and did not limit the course of the therapy or lead to patient withdrawal.

Unverified Answer

What does ide397 usually treat?

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Our clinic is not a cancer clinic. Patients will mostly get an endoscopy for the following indications; unexplained bleeding from anywhere unexplained anaemia unexplained iron deficiencies as a result of bleeding disorders anorexia unexplained weight loss unexplained fatigue a unexplained fever unexplained abdominal pain unexplained dizziness unexplained vomiting unexplained pain-related nausea. Most of the time, this is a normal result, and we just reassure our patients about that.

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Who should consider clinical trials for cancer?

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Trial participation by cancer patients and patient/guardian involvement in trial decisions could impact on patient risk. It is desirable for patients to be informed of the risks and benefits of clinical trials.

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