Relapsed/refractory mature B cell lymphoma or advanced solid tumors Cancer
Conditions
Interventions
Current interventions as of 18/12/2025:
Dose escalation will be done separately and in parallel with two separate dose escalations: one in lymphoma and one in solid tumor patients. Dose-escalations
Sponsors
Bantam Pharmaceuticals
Eligibility
Sex/Gender
All
Age
18 Years to 110 Years
Inclusion criteria
Inclusion criteria: Current key inclusion criteria as of 18/12/2025: 1. Patients aged =18 years with a diagnosis of relapsed or refractory mature B cell lymphoma* or advanced, unresectable and/or metastatic solid tumors. 2. Patients with non-Hodgkin’s lymphoma (NHL) must have received at least 2 lines of prior therapy and have no available therapies in the investigator’s opinion with known clinical benefit; patients with advanced solid tumors should be refractory to or relapsed after all standard therapies known to provide proven clinical benefit, unless the patient is not a candidate for standard treatment, there is no standard treatment, or the patient refuses standard treatment after expressing an understanding of all available therapies with proven clinical benefit. For subjects who have refused standard treatment, a rationale for refusal to receive the treatment will be captured in the case report form (CRF) and the medical record. There is no limit to the number of prior treatment regimens. 3. For lymphoma, patient must have measurable disease at screening per Lugano classification. For advanced solid tumors, patient must have non-measurable and/or measurable disease at screening per the revised RECIST guideline (version 1.1). 4. Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 – 2 5. Patient must have a predicted life expectancy of >3 months 6. Patient must have the following laboratory values (obtained =21 days prior to enrollment): 6.1. High sensitivity cTnI 900 pg/mL or ng/L for 50-75; >1800 pg/mL or ng/L for age >75) 6.3. Serum CK 30 kg/m²; lean body weight must be used if BMI >30 kg/m² 6.5. Total bilirubin =1.5 × ULN unless has known history of Gilbert’s syndrome (in which case, total bilirubin must be =3 × ULN) 6.6. AST and ALT =2.5 × ULN, or =5 × ULN if due to liver involvement by tumor 6.7. Hemoglobin =8.0 g/dL 6.8. Platelets = 75 × 10? cells/L 6.9. Absolute neutrophil count =1.0 ×10? cells/L (without the use of hematopoietic growth factors) 6.10. Corrected QT interval (QTc) <470 ms for females and <450 ms for males (as calculated by the Fridericia correction formula) 6.11. LVEF = 50% or = LLN for their institution, whichever is higher 6.12. Women of child-bearing potential (WOCBP) must have a negative urine pregnancy test within 72 hours prior to first administration of BTM-3566 7. WOCBP and males with female partners of child-bearing potential must agree to use adequate birth control throughout their participation and for 90 days following the last dose of BTM-3566. 8. Patient must be willing to adhere to the study visit schedule and the prohibitions and restrictions specified in this protocol. 8.1. Patient should have a site of disease amenable to biopsy and be a candidate for tumor biopsy according to institutional guidelines. Patients should be willing to undergo a new tumor biopsy at baseline and after dose 2 to 4 in either Cycle 1 or 2 of this study. Note: Patients with sites of disease not amenable to biopsy, or unwilling to undergo biopsies, will be considered for enrollment after discussion with the study PI. 8.2. Patients must not be enrolled in any other clinical trial and must not
Exclusion criteria
Exclusion criteria: Current key exclusion criteria as of 18/12/2025: 1. Patient has received the therapies/interventions listed below within the specified timeframe, or has ongoing toxicity from prior therapy > Grade 1 according to the CTCAE v5.0, with the exception of alopecia, vitiligo, Grade =2 neuropathy, well-controlled hypo/hyperthyroidism or other endocrinopathies that are well controlled with hormone replacement. Such exceptions must be assessed by the investigator (and approved by the sponsor) as not placing the patient at undue safety risk from participating in this study. 1.1. Patient has undergone a major surgery (excluding minor procedures, e.g., placement of vascular access) 2, pulmonary embolism, or symptomatic cerebrovascular events, or any other serious cardiac condition (e.g., pericardial effusion or restrictive cardiomyopathy). Chronic atrial fibrillation on stable anticoagulant therapy is allowed. 5. Patients with history of statin-associated myopathy within 6 months of enrollment who is still taking a statin. 6. Patient has symptomatic or uncontrolled neurologic disease (brain metastases, leptomeningeal disease, or spinal cord compression) not definitively treated with surgery or radiation. Note: Symptomatic or uncontrolled neurologic disease is defined as patient has active CNS metastases (including evidence of cerebral edema by MRI, or progression from prior imaging study, or any requirement for steroids, or clinical symptoms of/from CNS metastases) within 28 days prior to study treatment. Patients with known CNS metastases must have a baseline MRI scan within 28 days of study treatment. 7. Patient has current second malignancy at other sites (exceptions: non-melanomatous skin cancer, adequately treated in situ carcinoma, or indolent prostate cancer under observation). A history of other malignancies is allowed at the discretion of the PI and medical monitor as long as patient has been free of recurrence for =2 years, or if the patient has been treated with curative intent within the p
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose limiting toxicity of BTM-3566 using the incidence and severity of adverse events measured using Common Terminology Criteria for Adverse Events (CTCAE) v5.0 at every study visit for the first 28 days on treatment (i.e. C1D1, C1D2, C1D3, C1D7, C1D9, C2D1, C2D3) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of BTM-3566 using the incidence and severity of adverse events experienced during the first 4 weeks of treatment measured using Common Terminology Criteria for Adverse Events (CTCAE) v5.0 at every study visit for the first 28 days on treatment (i.e. C1D1, C1D2, C1D3, C1D7, C1D9, C2D1, C2D3) 2. The pharmacokinetic properties of BTM-3566 measured via plasma concentrations of BTM-3566 at C1D1, C1D2, C1D7, C1D9, C2D1 3. The clinical activity of BTM-3566 measured through Objective Response Rate and Duration of Response by Revised Lugano Criteria at C3D1, and every 12 weeks thereafter, and Progression-Free Survival and Overall Survival measured using length of survival at each study visit and every 3 months post-treatment for up to 5 years or until death | — |
Countries
Canada
Contacts
Public ContactSarah Young
Outcome results
None listed