Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
10 MBq/kg Betalutin · 2 trials · 4 indications
Safety and tolerability of Betalutin in combination with rituximab as determined by the frequency and severity of adverse events (CTCAE v4.03) in the first 12 weeks after Betalutin
Number of participants with dose limiting toxicities (DLTs) in Part A
Tumour response rates in patients in Part A receiving Betalutin based on evaluation of CT scan images including PET/CT imaging (and bone marrow biopsy if applicable).
Overall response rate in Part B defined as the number of participants with a best response of complete remission or partial remission at any time
| Arm | Type | Description |
|---|---|---|
| 10 MBq/kg Betalutin with rituximab treatment | EXPERIMENTAL | 10 MBq/kg Betalutin administered with lilotomab pre-dose on day 0; rituximab administered weekly x 4 doses from day 7, then every 3 months for 2 years |
| 15 MBq/kg Betalutin with rituximab treatment | EXPERIMENTAL | 15 MBq/kg Betalutin administered with lilotomab pre-dose on day 0; rituximab administered weekly x 4 doses from day 7, then every 3 months for 2 years |
| Part A, Arm 1: 10 MBq/kg Betalutin with lower dose lilotomab pre-dosing | EXPERIMENTAL | 10 MBq/kg (based on body weight) Betalutin with 40 mg lilotomab pre-dosing |
| Part A, Arm 1: 15 MBq/kg Betalutin with lower dose lilotomab pre-dosing | EXPERIMENTAL | 15 MBq/kg (based on body weight) Betalutin with 40 mg lilotomab pre-dosing |
| Part A, Arm 1: 20 MBq/kg Betalutin with lower dose lilotomab pre-dosing | EXPERIMENTAL | 20 MBq/kg (based on body weight) Betalutin with 40 mg lilotomab pre-dosing |
| Part A, Arm 2: 10 MBq/kg Betalutin with no pre-dosing | EXPERIMENTAL | 10 MBq/kg (based on body weight) Betalutin without pre-dosing |
| Part A, Arm 2: 15 MBq/kg Betalutin with no pre-dosing | EXPERIMENTAL | 15 MBq/kg (based on body weight) Betalutin without pre-dosing |
| Part A, Arm 3: 15 MBq/kg Betalutin with rituximab pre-dosing | EXPERIMENTAL | 15 MBq/kg (based on body weight) Betalutin with rituximab pre-dosing |
| Part A, Arm 4: 15 MBq/kg Betalutin with higher dose lilotomab pre-dosing | EXPERIMENTAL | 15 MBq/kg (based on body weight) Betalutin with 100 mg/m2 (based on body surface area) lilotomab pre-dosing |
| Part A, Arm 4: 20 MBq/kg Betalutin with higher dose lilotomab pre-dosing | EXPERIMENTAL | 20 MBq/kg (based on body weight) Betalutin with 100 mg/m2 (based on body surface area) lilotomab pre-dosing |
| Part A, Arm 5: 20 MBq/kg Betalutin with intermediate dose lilotomab pre-dosing | EXPERIMENTAL | 20 MBq/kg (based on body weight) Betalutin with 60 mg/m2 (based on body surface area) lilotomab pre-dosing |
| Part B, Arm 1: 15 MBq/kg Betalutin with lower dose lilotomab pre-dosing | EXPERIMENTAL | 15 MBq/kg (based on body weight) Betalutin with 40 mg lilotomab pre-dosing |
| Part B, Arm 2: 20 MBq/kg Betalutin with higher dose lilotomab pre-dosing | EXPERIMENTAL | 20 MBq/kg (based on body weight) Betalutin with 100 mg/m2 (based on body surface area) lilotomab pre-dosing |
| Part B, Arm 3: 12.5 MBq/kg Betalutin with lower dose lilotomab pre-dosing | EXPERIMENTAL | 12.5 MBq/kg (based on body weight) Betalutin with 40 mg lilotomab pre-dosing |
| Part C: 15 MBq/kg Betalutin with lower dose lilotomab pre-dosing | EXPERIMENTAL | 15 MBq/kg (based on body weight) Betalutin with 40 mg lilotomab pre-dosing |
| Name | Type | Description |
|---|---|---|
| 10 MBq/kg Betalutin | DRUG | 10 MBq/kg Betalutin, lilotomab 40mg, rituximab 375 mg/m2 |
| 15 MBq/kg Betalutin | DRUG | 15 MBq/kg Betalutin, lilotomab 40mg, rituximab 375 mg/m2 |
| 20 MBq/kg Betalutin | DRUG | - |
| 40 mg lilotomab | DRUG | - |
| 100 mg/m2 lilotomab | DRUG | - |
| 60 mg/m2 lilotomab | DRUG | - |
| Rituximab | DRUG | - |
| 12.5 mBq/kg Betalutin | DRUG | - |
Inclusion Criteria: * Patient must be ≥18 years at the time of signing the informed consent * ECOG performance status of 0-2 * Histologically confirmed diagnosis (by 2008 World Health Organization \[WHO\] classification) of follicular lymphoma (grade 1, 2 or 3a) * At least one (but not more than 3)...
10 MBq/kg Betalutin is an investigational small molecule being studied for the treatment of Non-Hodgkin Lymphoma, including follicular lymphoma. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
10 MBq/kg Betalutin is being developed by Icon Plc, a company traded on the NASDAQ under the ticker symbol ICLR. The drug is in Phase 1 clinical development for Non-Hodgkin Lymphoma.
10 MBq/kg Betalutin is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. Clinical trials are ongoing to evaluate its safety and efficacy.
10 MBq/kg Betalutin has been studied in two completed clinical trials. NCT01796171 was a Phase 1/2 study in relapsed Non-Hodgkin Lymphoma with 191 participants, and NCT03806179 was a Phase 1 study of Betalutin with rituximab in follicular lymphoma with 7 participants.
Yes, 10 MBq/kg Betalutin is a specific dose of the drug Betalutin. The clinical trials referenced in the development program use the name Betalutin, and 10 MBq/kg refers to the dose being administered in the study.