BTM-3566 in Advanced Solid Tumors

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

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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: Drug: BTM-3566

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Kapadi BTM-3566 Project Manager; Phone Number: 984-849-4400; Email: BTM3566@kapadi.com
• Study Contact Backup: Name: Bantam Chief of Staff; Phone Number: 646-598-4823; Email: info@bantampharma.com

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77054
      • Recruiting
      • Next Houston
      • Contact: Emma Clinical Trial Navigator; Phone Number: 832-384-7912; Email: emorales@nextoncology.com
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • NEXT Oncology
      • Contact: Clinical Trial Navigator; Phone Number: 210-580-9521; Email: jgeorg@nextoncology.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

• Any advanced, unresectable and/or metastatic solid tumors except for primary brain cancer, breast cancer, prostate cancer, pancreatic cancer, pheochromocytoma, fibrolamellar carcinoma, adrenocortical carcinoma, or ocular or cutaneous melanoma.
• 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

Key Exclusion Criteria:

• Has not completed appropriate wash-out timeframes of prior anti-cancer treatments
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BTM-3566; Daily oral dosing (7 days on/7 days off)	Drug: BTM-3566; BTM-3566

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency and type of dose limiting toxicities	Frequency and type of dose limiting toxicities associated with each dose level of BTM-3566	28 days
Frequency and severity of adverse events	Frequency and severity of adverse events according to NCI-CTCAE v 5.0	Through study completion, estimated 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic properties of BTM-3566	Plasma concentration of BTM-3566 at each time point	30 days
Clinical activity of BTM-3566	Objective Response Rate by RECIST 1.1	Through study completion, estimated 2 years
Clinical activity of BTM-3566	Progression Free Survival per RECIST 1.1 principles	Through study completion, estimated 2 years
Clinical activity of BTM-3566	Overall Survival	Through study completion, estimated 2 years
Clinical activity of BTM-3566	Clinical Benefit Rate (proportion of patients having at least stable disease) according to RECIST 1.1 principles	Through study completion, estimated 2 years
Clinical activity of BTM-3566	Duration of Response, per RECIST 1.1 principles	Through study completion, estimated 2 years

Collaborators and Investigators

• Sponsor: Bantam Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: November 18, 2025
• First Submitted That Met QC Criteria: November 24, 2025
• First Posted (Estimated): December 5, 2025

Study Record Updates

• Last Update Posted (Actual): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 10, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Phase 1; Dose escalation; Advanced Solid Tumors
• Other Study ID Numbers: BTM-3566-001-ST

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: This is an exploratory proof of concept study with no formal hypothesis testing and may not be suitable for publication in a peer-reviewed journal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No