Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
30 participants
INTERVENTIONAL
2025-12-10
2027-08-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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BTM-3566
Daily oral dosing (7 days on/7 days off)
BTM-3566
BTM-3566
Interventions
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BTM-3566
BTM-3566
Eligibility Criteria
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Inclusion Criteria
* Must be refractory/relapsed after all standard therapies known to provide proven clinical benefit
* ECOG Performance Status 0 to 2
* Adequate organ function as defined by pre-specified laboratory values
* Life expectancy \> 3 months
* Women of child-bearing potential (or males with female partners of child-bearing potential) must agree to use adequate contraceptive measures throughout the study and for 90 days following last dose
Exclusion Criteria
* Has ongoing toxicities from prior anti-cancer treatments
* Has symptomatic or uncontrolled neurologic disease
* Has active and clinically significant bacterial, fungal or viral infection
* Cannot avoid use of moderate or strong CYP3A4 inhibitors or inducers; CYP2C19 substrates or OAT2 substrates with narrow therapeutic index; or drugs that prolong the QT interval throughout the study
* Has previously received a total anthracycline dose ≥ 360mg/m2 doxorubicin or equivalent
* Has a history of serious cardiac conditions or pulmonary or cerebrovascular events within 6 months of first dose
* Is pregnant or breastfeeding
18 Years
ALL
No
Sponsors
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Bantam Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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NEXT Houston
Houston, Texas, United States
NEXT Oncology
San Antonio, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BTM-3566-001-ST
Identifier Type: -
Identifier Source: org_study_id