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New cancer drug BTM-3566 enters first human tests

NCT ID NCT07266285

Disease control Sponsor: Bantam Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial is testing a new drug called BTM-3566 in 30 adults with advanced solid tumors that have not responded to standard treatments. The main goals are to find safe doses and understand side effects. Participants take the drug for 7 days on and 7 days off, and researchers will also look for any signs that the drug shrinks tumors or slows cancer growth.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BTM-3566
What this could lead to
If this trial succeeds, it could point toward a new treatment option for people with advanced solid tumors who have run out of standard therapies.
What could go wrong
This is a very early (Phase 1) trial with only 30 participants, so the drug may not prove effective or may have serious side effects. It is too soon to know if it will work in larger groups.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced solid tumors

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    2 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • NEXT Houston

    RECRUITING

    Houston, Texas, 77054, United States

  • NEXT Oncology

    RECRUITING

    San Antonio, Texas, 78229, United States

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