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BTM-3566 for Advanced Solid Tumors

This study is testing a drug called BTM-3566 in adults with advanced solid tumors that have not responded to standard treatments. The main goals are to find out what doses of BTM-3566 are safe and what side effects (toxicities) it might cause. Researchers also want to see how well BTM-3566 works to shrink tumors or stop cancer from getting worse. You would receive BTM-3566, and no one in this study will receive a placebo (a look-alike substance without medicine). The study is currently unclear on its recruitment status and plans to enroll about 30 participants.

Study design
This is a Phase 1, open-label study, meaning both you and the study team will know you are receiving BTM-3566. It will involve a small number of participants to find the right dose.
What's involved
You will take BTM-3566 for 7 days, followed by a 7-day break. The study will measure side effects for up to 2 years.
Compensation
Not stated in the trial record.
Follow-up
The study will track adverse events (side effects) through study completion, estimated to be 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07266285

BTM-3566 in Advanced Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
Bantam Pharmaceuticals
~30 participants
Updated 2025-12-17 on ClinicalTrials.gov
What's tested:BTM-3566

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Frequency and type of dose limiting toxicities
Measured over 28 days
+1 more outcome measured

Conditions

Advanced Solid Tumors

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Solid Neoplasm

NCT07266285

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • NEXT Houston

    Houston, Texasstudy coordinator listed

    Recruiting

  • NEXT Oncology

    San Antonio, Texasstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Kapadi BTM-3566 Project Manager
[email protected]
984-849-4400
Email the study team

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • Frequency and type of dose limiting toxicities28 days

    Frequency and type of dose limiting toxicities associated with each dose level of BTM-3566

  • Frequency and severity of adverse eventsThrough study completion, estimated 2 years

    Frequency and severity of adverse events according to NCI-CTCAE v 5.0