BTM-3566 for advanced solid tumors
A Phase 1 Trial of BTM-3566 in Advanced Solid Tumors
PHASE1 · Bantam Pharmaceuticals · NCT07266285
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 | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Bantam Pharmaceuticals (industry) |
| Drugs / interventions | doxorubicin |
| Locations | 2 sites (Houston, Texas and 1 other locations) |
| Trial ID | NCT07266285 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Houston, Texas and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Advanced Solid Tumors, Phase 1, Dose escalation