NCT07266285

BTM-3566 in Advanced Solid Tumors

A Phase 1 Trial of BTM-3566 in Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Bantam Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This study is a phase 1, open label, dose escalation study using single participant cohorts followed by 3+3 design to evaluate multiple ascending doses of BTM-3566.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	BTM-3566	BTM-3566

Timeline

• Start date: 2025-12-10
• Primary completion: 2027-02-01
• Completion: 2027-08-01
• First posted: 2025-12-05
• Last updated: 2025-12-17

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study