BTM-3566 for Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the safety and effectiveness of a new drug, BTM-3566, for adults with advanced solid tumors. The main goal is to determine the right dose and assess whether it shrinks tumors or prevents cancer from worsening. Participants will take the drug for 7 days, followed by a 7-day break, repeating this cycle until their condition changes. Those who have exhausted all other treatments and have specific types of solid tumors (excluding a few listed types) might be suitable candidates. Participants must also visit the clinic regularly and maintain a treatment diary. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects on people.
Will I have to stop taking my current medications?
The trial requires that you avoid certain medications, specifically moderate or strong CYP3A4 inhibitors or inducers, CYP2C19 substrates, OAT2 substrates with a narrow therapeutic index, and drugs that prolong the QT interval. If you are taking any of these, you may need to stop or switch medications.
Is there any evidence suggesting that BTM-3566 is likely to be safe for humans?
Research shows that BTM-3566 is under careful study for safety in adults with cancer. In earlier studies with patients who had relapsed or difficult-to-treat B-cell lymphomas, researchers examined how well patients tolerated the drug. These studies are ongoing, focusing on understanding the drug's mechanism and its effects on the body.
As BTM-3566 is in early testing stages, the main goal is to find a safe dose and identify any side effects. While specific results from these studies aren't fully available yet, this testing phase is crucial to ensure the drug's safety before wider use. Participants in these studies help researchers learn about any potential harmful side effects.12345Why do researchers think this study treatment might be promising?
Unlike traditional cancer treatments, which often involve chemotherapy or radiation targeting rapidly dividing cells, BTM-3566 operates with a unique mechanism. It is designed to be taken orally and works by targeting specific molecular pathways associated with cancer growth, potentially leading to fewer side effects. Researchers are excited about BTM-3566 because its innovative approach might offer a more targeted and personalized treatment option, providing hope for improved outcomes and quality of life for cancer patients.
What evidence suggests that BTM-3566 might be an effective treatment for cancer?
Research has shown that BTM-3566, the investigational treatment in this trial, may help treat certain types of cancer. In earlier studies, it proved effective against B-cell cancers, particularly diffuse large B-cell lymphoma (DLBCL) and mantle cell lymphoma (MCL). Tests on animals demonstrated that the treatment could completely shrink tumors. Another study found that BTM-3566 quickly reduced a protein called DELE1-L, which aids cancer cell survival. These results suggest that BTM-3566 might effectively shrink tumors and slow cancer growth.12567
Are You a Good Fit for This Trial?
This trial is for adults with advanced solid tumors, excluding certain cancers like brain, breast, prostate, and others. Participants must have tried all standard treatments without success and should be in a relatively stable condition (ECOG 0-2), with a life expectancy over 3 months. They need good organ function and agree to use contraception during the study.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive BTM-3566 with a dosing schedule of 7 days on/7 days off until disease progression or intolerance
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- BTM-3566
Trial Overview
The trial tests different doses of BTM-3566 to find safe levels and measure its effectiveness against cancer. Patients will take BTM-3566 on a schedule of 7 days on/7 days off until their disease worsens or side effects become intolerable. No placebos are used; all participants receive the drug.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Daily oral dosing (7 days on/7 days off)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Bantam Pharmaceuticals
Lead Sponsor
Citations
A phase 1 trial of BTM-3566 in relapsed/refractory mature B ...
BTM-3566, a novel compound demonstrated efficacy against diverse B-cell malignancies, with the most pronounced impact observed in DLBCL and MCL.
Targeting Aggressive B-cell Lymphomas through ...
BTM-3566 treatment resulted in a loss of DELE1-L by 60 minutes of treatment to a greater degree than that of a positive control, oligomycin.
3.
aacrjournals.org
aacrjournals.org/bloodcancerdiscov/article/3/5_Supplement/A07/708648/Abstract-A07-BTM-3566-a-novel-activator-of-theAbstract A07: BTM 3566, a novel activator of the mitochondrial ...
In xenograft models using the double-hit DLBCL line SU-DHL-10, BTM-3566 treatment resulted in complete response in all tumor-bearing animals ...
Phase 1 Trial of BTM-3566 in Relapsed/Refractory Mature ...
Beginning at Cycle 5, imaging will be repeated every 3 months (or as clinically indicated) for up to 12 months, and every 6 months thereafter, until disease ...
5.
prnewswire.com
prnewswire.com/news-releases/bantam-pharmaceutical-accelerates-btm-3566-clinical-program-expanding-phase-1-trial-into-canada-302393938.htmlBantam Pharmaceutical Accelerates BTM-3566 Clinical ...
In preclinical studies, BTM-3566 demonstrated potent anti-cancer activity, driving significant tumor regression – and in many cases, complete ...
6.
ddw-online.com
ddw-online.com/trial-evaluating-treatment-for-r-r-mature-b-cell-lymphomas-33966-202503/Trial evaluating treatment for R/R mature B-cell lymphomas
BTM-3566 is a first-in-class, small molecule cancer therapeutic which targets mitochondrial homeostasis via the ATF4-Integrated Stress Response ...
An early phase trial to test the safety and determine the ...
Patient has received any anti-cancer therapy <28 days prior to administration of BTM-3566. 1.3. Patient has received radiation therapy <28 days ...
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