BTM-3566 in Advanced Solid Tumors
ConditionAdvanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorBantam Pharmaceuticals
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
BTM-3566
DrugBTM-3566
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: BTM-3566Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Frequency and type of dose limiting toxicities
Frequency and type of dose limiting toxicities associated with each dose level of BTM-3566
Time frame
28 days2
Frequency and severity of adverse events
Frequency and severity of adverse events according to NCI-CTCAE v 5.0
Time frame
Through study completion, estimated 2 yearsSecondary outcomes
1
Pharmacokinetic properties of BTM-3566
Plasma concentration of BTM-3566 at each time point
Time frame
30 days2
Clinical activity of BTM-3566
Objective Response Rate by RECIST 1.1
Time frame
Through study completion, estimated 2 years3
Clinical activity of BTM-3566
Progression Free Survival per RECIST 1.1 principles
Time frame
Through study completion, estimated 2 years4
Clinical activity of BTM-3566
Overall Survival
Time frame
Through study completion, estimated 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov