Advanced Solid TumorsPhase 1NCT07266285
BTM-3566 in Advanced Solid Tumors
A Phase 1 study testing BTM-3566 in people with Advanced Solid Tumors, run by Bantam Pharmaceuticals at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- BTM-3566
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Dec 2025to Aug 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
NEXT Houston
Houston, Texas, 77054
Emma Clinical Trial Navigator, 832-384-7912, emorales@nextoncology.com
- Recruiting
NEXT Oncology
San Antonio, Texas, 78229
Clinical Trial Navigator, 210-580-9521, jgeorg@nextoncology.com
About this study
Official title: 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).
Read more
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.
Read the 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.
- Conditions
- Advanced Solid Tumors
- Being tested
- BTM-3566
- Keywords
- Advanced Solid Tumors, Phase 1, Dose escalation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BTM-3566Drug
BTM-3566
| Study group | Role | What they receive |
|---|---|---|
| BTM-3566 | Experimental | Daily oral dosing (7 days on/7 days off) Receives: Drug: BTM-3566 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and type of dose limiting toxicities
Frequency and type of dose limiting toxicities associated with each dose level of BTM-3566
Measured: 28 days
Frequency and severity of adverse events
Frequency and severity of adverse events according to NCI-CTCAE v 5.0
Measured: Through study completion, estimated 2 years
Secondary outcomes (6)
Pharmacokinetic properties of BTM-3566
Plasma concentration of BTM-3566 at each time point
Measured: 30 days
Clinical activity of BTM-3566
Objective Response Rate by RECIST 1.1
Measured: Through study completion, estimated 2 years
Clinical activity of BTM-3566
Progression Free Survival per RECIST 1.1 principles
Measured: Through study completion, estimated 2 years
Clinical activity of BTM-3566
Overall Survival
Measured: 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
Measured: Through study completion, estimated 2 years
Clinical activity of BTM-3566
Duration of Response, per RECIST 1.1 principles
Measured: Through study completion, estimated 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start10 Dec 2025
- Primary completionFeb 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bantam Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07266285
- Sponsor's protocol ID
- BTM-3566-001-ST
- Status last verified
- Dec 2025
- First submitted
- 18 Nov 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Trial of BTM-3566 in Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07266285
- Acronym / sponsor ID
- BTM-3566-001-ST
- Conditions
- Advanced Solid Tumors
- Keywords
- Advanced Solid Tumors, Phase 1, Dose escalation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Bantam PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 10 Dec 2025 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 5 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BTM-3566 | Experimental | Drug: BTM-3566Daily oral dosing (7 days on/7 days off) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BTM-3566BTM-3566 | Drug | BTM-3566 |
Primary outcome
Frequency and type of dose limiting toxicities
Time frame: 28 days
Frequency and type of dose limiting toxicities associated with each dose level of BTM-3566
Frequency and severity of adverse events
Time frame: Through study completion, estimated 2 years
Frequency and severity of adverse events according to NCI-CTCAE v 5.0
6 secondary outcomes
Pharmacokinetic properties of BTM-3566
Time frame: 30 days
Clinical activity of BTM-3566
Time frame: Through study completion, estimated 2 years
Clinical activity of BTM-3566
Time frame: Through study completion, estimated 2 years
Clinical activity of BTM-3566
Time frame: Through study completion, estimated 2 years
Clinical activity of BTM-3566
Time frame: Through study completion, estimated 2 years
Clinical activity of BTM-3566
Time frame: Through study completion, estimated 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BTM-3566 in people with Advanced Solid Tumors, run by Bantam Pharmaceuticals at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kapadi BTM-3566 Project Manager (984-849-4400, BTM3566@kapadi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency and type of dose limiting toxicities (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.