BTM-3566 in Advanced Solid Tumors

NCT07266285 | Recruiting Phase 1 FDA Drug

• 1 other identifier: BTM-3566-001-ST
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Advanced Solid Tumors

Keywords

Advanced Solid Tumors; Phase 1; Dose escalation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Pharmacokinetic properties of BTM-3566

  30 days

• Clinical activity of BTM-3566

  Through study completion, estimated 2 years

• Clinical activity of BTM-3566

  Through study completion, estimated 2 years

• Clinical activity of BTM-3566

  Through study completion, estimated 2 years

• Clinical activity of BTM-3566

  Through study completion, estimated 2 years

Study Arms (1)

BTM-3566

EXPERIMENTAL

Daily oral dosing (7 days on/7 days off)

Drug: BTM-3566

Interventions

BTM-3566 DRUG

BTM-3566

BTM-3566

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bantam Pharmaceuticals: lead

Study Sites (2)

NEXT Houston

Houston, Texas, 77054, United States

RECRUITING

NEXT Oncology

San Antonio, Texas, 78229, United States

RECRUITING

Central Study Contacts

Kapadi BTM-3566 Project Manager

CONTACT

984-849-4400; BTM3566@kapadi.com

Bantam Chief of Staff

CONTACT

646-598-4823; info@bantampharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: December 5, 2025
• Study Start: December 10, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: December 17, 2025

Record last verified: 2025-12

Locations

US (2)