Recruiting
Phase 1

BTM-3566

Sponsor:

Bantam Pharmaceuticals

Code:

NCT07266285

Conditions

Advanced Solid Tumors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BTM-3566

Study Details

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

Study ID

NCT07266285

Start date

Dec 10, 2025

Status verified date

Dec, 2025

Completion date

Aug, 2027

Anticipated

Primary completion date

Feb, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: BTM-3566

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

Interventions

BTM-3566

BTM-3566

Primary outcome measure

  • Frequency and type of dose limiting toxicities [ Time Frame: 28 days ]
  • Frequency and severity of adverse events [ Time Frame: Through study completion, estimated 2 years ]

Central Contacts and Locations

Central contacts

Kapadi BTM-3566 Project Manager

984-849-4400BTM3566@kapadi.com

Bantam Chief of Staff

646-598-4823info@bantampharma.com

Locations

NEXT Houston

Recruiting

Houston, Texas, United States, 77054

Contacts

Emma Clinical Trial Navigator

832-384-7912emorales@nextoncology.com

NEXT Oncology

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Clinical Trial Navigator

210-580-9521jgeorg@nextoncology.com

More Information

Sponsor

Bantam Pharmaceuticals

Last update posted

Dec 17, 2025

Last verified

Dec, 2025

Keywords

  • Advanced Solid Tumors
  • Phase 1
  • Dose escalation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Bantam Pharmaceuticals on 2025-12-17.