BTM-3566 in Advanced Solid Tumors

Part of paid clinical trials in Houston, Texas.

Sponsor
Bantam Pharmaceuticals
Study ID
NCT07266285
Phase
PHASE1
Status
Recruiting

Conditions

  • Advanced Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BTM-3566 — DRUG
    BTM-3566

Study Details

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.

Key Dates

Start date
Dec 10, 2025
Status verified
Dec 2025
Primary completion
Feb 28, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: BTM-3566
    Daily oral dosing (7 days on/7 days off)

Primary Outcome Measure

Frequency and type of dose limiting toxicities [ Time Frame: 28 days ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
NEXT HoustonHoustonTexas77054
Emma Clinical Trial Navigator
832-384-7912
NEXT OncologySan AntonioTexas78229
Clinical Trial Navigator
210-580-9521

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