BTM-3566 for advanced solid tumors
Official title: A Phase 1 Trial of BTM-3566 in Advanced Solid Tumors
Run by Bantam Pharmaceuticals · NCT07266285 · Data updated 2026-11-12
This phase 1 trial will test if BTM-3566 is safe and can shrink or slow advanced solid tumors in adults who have exhausted standard treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Bantam Pharmaceuticals Industry-sponsored |
| Drugs / interventions | doxorubicin |
| Locations | 2 sites (Houston, Texas and 1 other locations) |
| Status | Recruiting |
| Started | December 10, 2025 |
| Main results expected | February 2027 |
| Study ends | August 2027 |
| Registry record updated | December 17, 2025 |
| Trial ID | NCT07266285 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with advanced, unresectable, or metastatic solid tumors (excluding primary brain cancer, breast, prostate, pancreatic, pheochromocytoma, fibrolamellar carcinoma, adrenocortical carcinoma, and ocular or cutaneous melanoma) who have progressed after all standard therapies, have ECOG 0–2, adequate organ function, and life expectancy greater than 3 months are the intended candidates.
✕Probably not a fit
Patients with the excluded tumor types, those who have not completed required washout from prior treatments, have ongoing toxicities from prior therapies, uncontrolled neurologic disease, active serious infections, or who cannot tolerate the dosing schedule are unlikely to benefit from this trial.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an open-label phase 1 dose-escalation trial of BTM-3566 in adults with advanced, unresectable, or metastatic solid tumors. The study starts with single-participant dose cohorts followed by a traditional 3+3 escalation design to find safe dose levels and characterize side effects. Participants take BTM-3566 for 7 days, then have a 7-day break, repeating that schedule until disease progression or unacceptable toxicity; blood samples will be taken to measure drug levels and tumor scans will track responses. The trial is sponsored by Bantam Pharmaceuticals and is conducted at NEXT Houston and NEXT Oncology in San Antonio, Texas.
Why it matters
Potential benefit: If successful, BTM-3566 could become a new treatment option that shrinks or stabilizes tumors for patients with advanced solid cancers who have no remaining standard therapies.
How similar studies have gone: This dose-escalation approach is a common first-in-human strategy in oncology; while other early-phase agents have shown benefit in some cancers, BTM-3566 itself is novel and unproven in humans.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
NEXT Houston
Houston, Texas, United States Recruiting -
NEXT Oncology
San Antonio, Texas, United States Recruiting
Study contacts
- Study coordinator: Kapadi BTM-3566 Project Manager
- Email: BTM3566@kapadi.com
- Phone: 984-849-4400
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
CG-7321: a first-in-human test in advanced solid tumors
We’re testing CG-7321 alone and with fulvestrant to see if it’s safe and tolerable in adults with advanced solid tumors.
-
AK157D1 injection for advanced solid tumors
A first-in-human Phase 1 study tests AK157D1 injection in adults with unresectable advanced solid tumors to see if it is safe and tolerable and to get early signs of how it behaves in the body and against tumors.
-
ABBV-253 in adults with advanced solid tumors
This study tests ABBV-253 to see if it is safe, how it affects the cancer, and how the drug moves in the body for adults with advanced solid tumors.
-
MK-2010 alone or with other treatments for advanced solid tumors
This trial tests MK-2010, by itself or with other cancer medicines, to see if it helps people with advanced solid tumors.
-
Whole-Body Infrared Heating for Advanced Solid Tumors
This study looks at how ET-SPACE whole-body infrared hyperthermia affects people with advanced solid tumors to see if it changes biology, symptoms, and safety.
-
MK-2010 with Sac-TMT in advanced solid tumors
This study tests MK-2010 combined with sacituzumab tirumotecan (sac-TMT) to see if it can help people with advanced solid tumors.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.