Actively Recruiting
BTM-3566 in Advanced Solid Tumors
Led by Bantam Pharmaceuticals · Updated on 2025-12-17
30
Participants Needed
2
Research Sites
85 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to learn about what doses of BTM-356 are safe to use in adults with advanced cancers in solid tumors. It will also learn about how effective different doses of BTM-3566 are in treating cancer. The main questions it aims to answer are: What adverse events and toxicities (harmful side effects) are associated with different doses of BTM-3566? What are the blood levels of BTM-3566 in your body at different timepoints? What effect does BTM-3566 have on reducing tumor size and/or preventing the worsening of cancer? All participants will receive BTM-3566 and none will receive placebo (a look-alike substance that contains no drug). Participants will: * Take BTM-3566 for 7 days, then take a 7 day break. This 2 week dosing schedule of 7 days on/7 days off will continue until your disease worsens or you cannot tolerate treatment. * Visit the clinic approximately 7 times during screening and the first month of treatment. Visits will be reduced to approximately 2 visits per month after. * Keep a diary of when (and how much) BTM-3566 you take, along with how much you weigh on each dosing day.
CONDITIONS
Official Title
BTM-3566 in Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults with advanced, unresectable and/or metastatic solid tumors except primary brain cancer, breast cancer, prostate cancer, pancreatic cancer, pheochromocytoma, fibrolamellar carcinoma, adrenocortical carcinoma, or ocular or cutaneous melanoma
- Cancer must be refractory or relapsed after all standard therapies known to provide proven benefit
- ECOG Performance Status between 0 and 2
- Adequate organ function based on laboratory tests
- Life expectancy greater than 3 months
- Women of child-bearing potential and males with partners of child-bearing potential must agree to use effective contraception during the study and for 90 days after last dose
You will not qualify if you...
- Has not completed required wash-out periods from prior anti-cancer treatments
- Has ongoing side effects from previous anti-cancer treatments
- Has symptomatic or uncontrolled neurological disease
- Has active, clinically significant bacterial, fungal, or viral infection
- Cannot avoid using certain drugs that interact with CYP3A4, CYP2C19, OAT2, or drugs that prolong the QT interval during the study
- Has previously received a total anthracycline dose of 360 mg/m2 doxorubicin or equivalent or higher
- Has a history of serious heart conditions or lung or cerebrovascular events within 6 months before first dose
- Is pregnant or breastfeeding
AI-Screening
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Trial Site Locations
Total: 2 locations
1
NEXT Houston
Houston, Texas, United States, 77054
Actively Recruiting
2
NEXT Oncology
San Antonio, Texas, United States, 78229
Actively Recruiting
Research Team
K
Kapadi BTM-3566 Project Manager
CONTACT
B
Bantam Chief of Staff
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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