BTM-3566 in Advanced Solid Tumors

NCT07266285 · tracked via the Priya Life Science USA tracker

Sponsor

Bantam Pharmaceuticals

Phase

Phase 1

Started

2025-12-10

Last updated

2025-12-17

Condition(s) studied

Advanced Solid Tumors

Investigational drug(s) / intervention(s)

BTM-3566 →

BTM-3566: BTM-3566

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

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

Trial sites (2)

Facility	City	Region	Status
NEXT Houston	Houston	Texas	Recruiting
NEXT Oncology	San Antonio	Texas	Recruiting

More Bantam Pharmaceuticals trials in the USA

Phase 1 Trial of BTM-3566 in Relapsed/Refractory Mature B Cell Lymphomas Recruiting

Other trials for the same condition

A First-In Human (FIH) Study to Find Out How Well REGN10597 Medicine Given Alone or in Combination With Cemiplimab Works in Adult Participants Who Have Cancer With Tumors That Have Spread in Their Body Recruiting

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Antitumor Activity of ALK201 in Participants With Advanced Solid Tumors Recruiting

A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-6036 Alone or in Combination in Participants With Advanced or Metastatic Solid Tumors With a KRAS G12C Mutation Active, not recruiting

A First-in-Human (FIH) Study to Evaluate the Safety and Tolerability of VVD-159642 in Participants With Advanced Solid Tumors Recruiting

A First-in-Human Study of CKD-703 in Advanced Solid Tumors and Non-Small Cell Lung Cancer Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07266285 on ClinicalTrials.gov ↗ ← All trials in the USA