IMSA101 for Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Atlantic Health System/Morristown Medical Center, Morristown, NJ
Cancer+1 More
IMSA101 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This study is evaluating whether a drug called IMSA101 may help treat patients with cancer.

See full description

Eligible Conditions

  • Cancer
  • Solid Tumors, Adult

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Cancer

Study Objectives

This trial is evaluating whether IMSA101 will improve 1 primary outcome and 2 secondary outcomes in patients with Cancer. Measurement will happen over the course of 2 years.

2 years
Maximum Tolerated Dose
Pharmacokinetic Sampling (Ph I)
4 years
Anti-tumor Effects

Trial Safety

Safety Progress

1 of 3

Other trials for Cancer

Trial Design

5 Treatment Groups

Ph I Combination Therapy
1 of 5
Ph II Combination Therapy (Arm B)
1 of 5
Ph II Monotherapy (Arm A)
1 of 5
Ph II Combination Therapy (Arm C)
1 of 5
Ph I Monotherapy
1 of 5
Experimental Treatment

This trial requires 115 total participants across 5 different treatment groups

This trial involves 5 different treatments. IMSA101 is the primary treatment being studied. Participants will be divided into 5 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Ph I Combination TherapyPh I combination dosing of IMSA101 shall be evaluated upon satisfaction of the following criteria: A given dose level (combo dose level 1) has been confirmed as safe for monotherapy dosing (i.e. 2/6 patients experience Cycle 1 DLT). The next higher dose level (combo dose level 2) has been confirmed as safe for monotherapy dosing (i.e. 2/6 patients experience Cycle 1 DLT). The dose level (combo dose level 1) is found to demonstrate adequate IMSA101 pharmacodynamic (PD) activity based on exploratory endpoints. Eligible patients shall have demonstrated RECIST stable disease through ≥ 4 consecutive cycles of an approved PD-1/PD-L1-targeted ICI with no Grade ≥ 3 CTCAE events considered to be drug-related. Safety evaluations and dose escalation of IMSA101 administered in combination with current therapy shall proceed in a manner consistent with monotherapy escalation and shall proceed independently of monotherapy dose escalation.
Ph II Combination Therapy (Arm B)This dose-expansion arm of 20 patients is intended to confirm the tolerability of the RP2D and identify provocative signals of IMSA101 anti-tumor activity when administered as combination therapy with PD-1/PD-L1 targeted immune checkpoint inhibitors. This arm shall include a safety run-in of 5-10 patients. Tumor type and corresponding treatment combination will be identified prior to Phase IIA commencement and documented in a protocol amendment.
Ph II Monotherapy (Arm A)
Drug
This dose-expansion arm of 20 patients is intended to confirm the tolerability of the RP2D and identify provocative signals of IMSA101 anti-tumor activity when administered as monotherapy Tumor type to be evaluated will be identified prior to Phase IIA commencement and will be documented in a protocol amendment.
Ph II Combination Therapy (Arm C)This dose-expansion arm of 20 patients is intended to confirm the tolerability of the RP2D and identify provocative signals of IMSA101 anti-tumor activity when administered as combination therapy with non-PD-1/PD-L1-targeted immuno-oncology (IO) drugs approved by the FDA. This arm shall include a safety run-in of 5-10 patients. Tumor type and corresponding treatment combination will be identified prior to Phase IIA commencement and documented in a protocol amendment..
Ph I Monotherapy
Drug
Dose escalation design in which administered dose levels of IMSA101 as monotherapy will be escalated stepwise in successive cohorts of 3 to 6 patients per dose group (using a standard 3+3 study design) of IMSA101 until the RP2D or maximum tolerated dose (MTD) level is identified. The first patient enrolled in each dose level must complete the first two weeks of Cycle 1 prior to enrolling the second and third patients. Dose levels to be evaluated include (although not necessarily limited to) 100 µg (representing 1/60th of the pre-clinical Highest Non-Severely Toxic Dose [HNSTD] dose), 200 µg, 400 µg, 800 µg, and 1,200 µg.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Immune checkpoint inhibitor (ICI)
2008
N/A
~2220

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 4 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 4 years for reporting.

Closest Location

Atlantic Health System/Morristown Medical Center - Morristown, NJ

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Signed informed consent and mental capability to understand the informed consent
Male or female patients > 18 years of age
Malignant melanoma
Hormone receptor negative breast cancer
Gastro-esophageal cancer
Non-small cell lung cancer
Head and neck cancer
Hepatoma
Renal cell carcinoma
Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1

Patient Q&A Section

What causes cancer?

"The development of cancer depends on the genetic mutation that causes them. This mutation, which may be a change in gene expression, can be caused by environmental factors such as pollution or radiation. Cancer tends to develop gradually from benign to malignant cancer. Other cancers such as thyroid cancer may develop either naturally or from environmental factors such as radiation. In order to prevent cancer, individuals must take control of modifiable risk factors. Dietary factors and cigarette smoking contribute to many of the cancers that cause most deaths." - Anonymous Online Contributor

Unverified Answer

Can cancer be cured?

"Treatment of brain tumors is difficult because of issues such as BBB. But, because a large part of brain tumour has not been found yet, researchers and clinicians have no means to cure cancer. The only cure is to diagnose it correctly and to treat it adequately at the earliest stage." - Anonymous Online Contributor

Unverified Answer

What are common treatments for cancer?

"Some forms of treatment can be provided using different treatment techniques and the patient's individual characteristics. However, a wide range of procedures are available for cancer treatment even though these vary in their effect and duration." - Anonymous Online Contributor

Unverified Answer

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

"Almost 20% of all cancer deaths are of people who were under the age of 50 years when deaths from cancer usually occur, and more than 95% of cancers occur outside health-system surveillance in these individuals. Cancer deaths and incidence rates are lower in older individuals than younger individuals. Cancer incidence also increases with age in most regions in the United States." - Anonymous Online Contributor

Unverified Answer

What are the signs of cancer?

"Signs of cancer are mostly nonspecific. They include signs of disease, signs of treatment effects, and signs of complications. It is important that physicians are aware of such signs so as to ensure early diagnosis and prompt treatment." - Anonymous Online Contributor

Unverified Answer

What is cancer?

"Cancer is a disease that can be traced to mutated cells in the body, which then grow or spread. Most cancers start in the body’s normal tissue, either in the skin, colon, breast, or brain. When cancers do form in a child it is usually harmless, such as skin cancer or brain tumors. However, cancer may occasionally grow and spread in children. Cancer is a disease that is relatively treatable if diagnosed early enough. It is estimated that 1 in 3 people will develop cancer in their lifetime. Understanding the signs and symptoms of cancer can help prevent it." - Anonymous Online Contributor

Unverified Answer

Is imsa101 safe for people?

"Imsa101 is safe with a low level of side effects across a wide range of indications. As our preliminary results show that this agent is safe and well tolerated in all ages, its use cannot be excluded in older patients at high risk of chemotherapy related toxicity." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving imsa101?

"There has been some speculation that the combination of imsa101 with radiotherapy might be more effective than radiotherapy alone, but further investigation is required before a clear answer to this question can be resolved. A clinical trial to test this hypothesis would have a number of advantages over other current treatments, but would have a small sample size and would require long follow-up, making its results less reliable. The evidence obtained so far would be less persuasive if we do not take into consideration the small but noteworthy number (almost 100,000) of patients and their treatment who have already been treated for cancer." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in imsa101 for therapeutic use?

"IMSA101 showed potent antiviral and antineoplastic effects in preclinical assays of cancer cell lines and a xenograft tumour-growth model. The novel observations are in accordance with observations by the FDA. Given that IMSA101 is in the pre-clinical stage and in advanced stages in human clinical trials, this reinforces its rationale as a therapeutic drug against cancer." - Anonymous Online Contributor

Unverified Answer

Has imsa101 proven to be more effective than a placebo?

"The effects of Imsa101 were significantly lower than that for a group that was given a placebo. The reason behind these findings remains unclear; however, it would be possible that some patients with the same condition are benefiting significantly more from Ima101 than others. More studies are in progress to ascertain the overall effect. The effects of Ima101 were greater than that for the placebo group, which was expected, as it was based on the results of previous studies. We believe Ima101 to be an effective treatment for the treatment of prostate cancer. But there is no evidence showing that Ima101 increases survival. More research is needed to confirm this effect." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating cancer?

"More research needs to be done before a treatment can be declared effective. The only one in the past couple of decades that has made a difference to patients with cancer is targeted therapy which is specifically focused on the cancer cells. Although they have been in use for at least ten years now, we are still waiting for an approved drug to be the breakthrough treatment for those with cancer that was used to treat metastatic breast cancer over the last decade." - Anonymous Online Contributor

Unverified Answer

What is imsa101?

"IMSA101 is a novel compound prepared from the bark of Imsa ajmonu, and appears to share many of the in vivo antitumor effects of the plant." - 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 Cancer by sharing your contact details with the study coordinator.