BTM-3566 in Advanced Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BTM-3566.
- Who it may be relevant to
- Registry conditions: Advanced Solid Tumors. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Phase 1 Trial of BTM-3566 in Advanced Solid Tumors
Overview
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.
Interventions
- Drug BTM-3566
BTM-3566
Primary outcome measures
- 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]
Secondary outcome measures (6)
- 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]
Eligibility criteria
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
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- NEXT Houston — Houston
- NEXT Oncology — San Antonio
Identifiers
NCT: NCT07266285 · BTM-3566-001-ST