Follicular Lymphoma, Non-Hodgkin Lymphoma
Conditions
Keywords
Radioimmunotherapy, Lu-177, Phase I study, Phase II study, Betalutin
Brief summary
This study is a Phase 1/2 open-label three part study in patients with relapsed indolent Non-Hodgkin's lymohoma (NHL) (Parts A and C) or relapsed/refractory follicular lymphoma (FL) (Part B).
Detailed description
Part A of the study was a Phase 1/2a study to assess the safety and preliminary efficacy of different treatment regimens of Betalutin with expansion at the candidate recommended Phase 2 doses. Part B was a dedicated Phase 2b randomized substudy to further assess the efficacy and safety of the candidate recommended Phase II doses. Part C was a Phase 2a fixed dose expansion cohort planned to obtain supplementary pharmacokinetic data.
Interventions
DRUG20 MBq/kg Betalutin
DRUG40 mg lilotomab
DRUG100 mg/m2 lilotomab
DRUG60 mg/m2 lilotomab
DRUGRituximab
DRUG12.5 mBq/kg Betalutin
Sponsors
ICON Clinical Research
Nordic Nanovector
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Part A and Part C: Inclusion Criteria: 1. Histologically confirmed (by World Health Organization \[WHO\] classification) relapsed incurable non-Hodgkin B-cell lymphoma of following subtypes; follicular grade I-IIIA (for Part C, this excludes patients meeting Part B criteria, who should enter Part B), marginal zone, small lymphocytic, lymphoplasmacytic, mantle cell. 2. Age ≥ 18 years. 3. Part A: A pre-study WHO performance status of 0-1; Part C: WHO performance status of 0-2. 4. Life expectancy should be ≥3 months. 5. \<25% tumour cells in bone marrow biopsy (biopsy taken from a site not previously irradiated). 6. Measurable disease by radiological methods. 7. Women of childbearing potential must: 1. understand that the study medication is expected to have teratogenic risk. 2. have a negative pregnancy test. 3. agree to use, and be able to comply with, effective contraception without interruption, 4 weeks before starting study medication, throughout study medication therapy and for 12 months after end of study medication therapy, even if she has amenorrhoea. 8. Male patients must agree to use condoms during intercourse throughout study medication therapy and the following 12 months. 9. Patients previously treated with native rituximab are eligible. 10. The patient is willing and able to comply with the protocol, and agrees to return to the hospital for follow up visits and examination. 11. The patient has been fully informed about the study and has signed the informed consent form.
Exclusion criteria
Medical contraindications, including uncontrolled infection, severe cardiac, pulmonary, neurologic, psychiatric or metabolic disease, uncontrolled asthma/allergy requiring systemic steroids, known to be human immunodeficiency virus (HIV) positive. 2\. Laboratory values within 15 days pre-registration: 1. Absolute neutrophil counts (ANC) ≤1.5×109/L. 2. Part A: Platelet count ≤150×109/L; Part C: Platelet count \<150×109/L. For Part C, criteria 2a and 2b must be satisfied within 72 hours of the administration of rituximab 3. Total bilirubin ≥30 mmol/L (Part A only). Total bilirubin \> 1.5×ULN (except patients with documented Gilbert's syndrome \[≥3.0 mg/dL\]) (Part C only). 4. Alkaline phosphatase (ALP) and alanine transaminase (ALT) ≥4×normal level (Part A only). Aspartate transaminase (AST), ALT or ALP \>2.5×ULN (or \>5.0×ULN with liver involvement by primary disease). (Part C only). 5. Creatinine ≥115 µmol/L (men), 97 µmol/L (women) (Part A only). Serum creatinine ≥1.5×ULN (Part C only). 6. Haemoglobin \<9.0 g/dL (Part C only). 3. Known central nervous system (CNS) involvement of lymphoma. 4. Previous total body irradiation. 5. Positive test for human anti-murine antibody (HAMA) at screening. 6. Chemotherapy or immunotherapy received within the last 4 weeks prior to start of study treatment. Pre treatment with rituximab is allowed. 7\. Pregnant or lactating women. 8. Previous hematopoietic stem cell transplantation (autologous and allogenic). 9. Part A: Previous treatment with radioimmunotherapy. Part C: Not applicable. 10. Actively participating in another study or received an IMP within 4 weeks prior to enrolment. 11\. Receipt of live-attenuated vaccine within 30 days prior to enrolment. 12. Part A and Part C: Test positive for hepatitis B (HBsAg and anti-HBc). Part C only: Test positive for hepatitis C and human immunodeficiency virus (HIV). 13\. A known hypersensitivity to rituximab, lilotomab, Betalutin or murine proteins or any excipient used in rituximab, lilotomab, or Betalutin. Part B: Inclusion Criteria: Histologically confirmed (by WHO classification) relapsed non-Hodgkin B-cell FL (grade I IIIA). 2\. Male or female aged ≥18 years. 3. Received at least 2 prior systemic anti-neoplastic or immunotherapy-based regimens (maintenance therapy following a CR/PR is not considered to be a separate line of therapy). Systemic regimens including agents such as idelalisib or other PI3K inhibitors qualify as a prior line of therapy. 4\. Prior therapy must have included a rituximab/anti-CD20 agent and an alkylating agent - which may be been administered in separate regimens. 5\. Patients must be refractory to any at least one previous regimen that contained rituximab or an anti CD20 agent, with refractoriness defined as: i. no response (no CR or PR) during therapy, or ii. a response (CR/PR) lasting less than 6 months after the completion of a regimen including rituximab/anti-CD20 therapy (including occurrence of progressive disease (PD) during rituximab/anti-CD20 maintenance therapy, or within 6 months of completion of maintenance therapy). 6\. WHO performance status of 0-2. 7. Life expectancy of ≥3 months. 8. Bone marrow tumour infiltration \<25% (in biopsy taken from a site not previously irradiated). 9\. Measurable disease by CT or MRI: longest diameter (LDi) \>1.5 cm for nodal lesion, LDi \>1.0 cm for extra nodal lesion on an assessment performed during the screening period. Criteria 10 and 11 must be satisfied within 72 hours of the administration of rituximab: 10\. ANC ≥1.5×109/L. 11. Platelet count ≥100×109/L. Criteria 12 to 15 must be verified at time of eligibility review within 2 weeks prior to rituximab administration: 12\. Haemoglobin ≥9.0 g/dL. 13. Total bilirubin ≤1.5×upper limit of normal (ULN) (except patients with documented Gilbert's syndrome \[\<3.0 mg/dL\]). 14\. Liver enzymes: AST; ALT or ALP ≤2.5×ULN (or ≤5.0×ULN with liver involvement by primary disease). 15\. Adequate renal function as demonstrated by a serum creatinine \<1.5×ULN. 16. Women of childbearing potential must: 1. understand that the study medication is expected to have teratogenic risk. 2. have a negative serum beta human-chorionic gonadotropin (ß-HCG) pregnancy test at screening. 3. commit to continued abstinence from heterosexual intercourse (excluding periodic abstinence or the withdrawal method) or begin a highly effective method of birth control with a Pearl-Index \<1%, without interruption, from 4 weeks before starting study medication, throughout study medication therapy and for 12 months after end of study medication therapy, even if she has amenorrhoea. Apart from abstinence, highly effective methods of birth control are: i. Combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal). ii. Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable) iii. Intrauterine device (IUD). iv. Intrauterine hormone-releasing system (IUS). v. Bilateral tubal occlusion. vi. Vasectomised partner. 17. Male patients must agree to use condoms during intercourse throughout study treatment administration and for 12 months following administration of Betalutin. 18\. The patient is willing and able to comply with the protocol, and agrees to return to the hospital for follow up visits and examination. 19\. The patient has been fully informed about the study and has signed the informed consent form. 20\. Negative HAMA test at screening. 21. Negative test at screening for Hepatitis B (negative HBsAg and anti-HBc), Hepatitis C and HIV.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part A, Phase I | 12 weeks | Number of participants with dose limiting toxicities (DLTs) in Part A |
| Part A, Phase IIa | 5 years | 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). |
| Part B, Phase IIb | up to 5 years | 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 |
Countries
Australia, Austria, Belgium, Canada, Croatia, Czechia, Denmark, Finland, France, Hungary, Ireland, Israel, Italy, Netherlands, Norway, Poland, Singapore, South Korea, Spain, Sweden, Switzerland, Turkey (Türkiye), United Kingdom, United States
Participant flow
Recruitment details
Patients were recruited in the Australia, Canada, the European Union, Israel, Norway, Singapore, Turkey, United Kingdom (UK) and United States (US)
Pre-assignment details
255 patients were screened in the 28 days before the start of treatment, 191 were enrolled, 190 started pre-treatment with rituximab (one enrolled participant died before starting rituximab) and 187 were treated with Betalutin
Participants by arm
| Arm | Count |
|---|---|
| Part A, Arm 1: 10 MBq/kg Betalutin With Lower Dose Lilotomab Pre-dosing 10 MBq/kg Betalutin
40 mg lilotomab | 4 |
| Part A, Arm 1: 15 MBq/kg Betalutin With Lower Dose Lilotomab Pre-dosing 15 MBq/kg Betalutin
40 mg lilotomab | 36 |
| Part A, Arm 1: 20 MBq/kg Betalutin With Lower Dose Lilotomab Pre-dosing 20 MBq/kg Betalutin
40 mg lilotomab | 3 |
| Part A, Arm 2: 10 MBq/kg Betalutin With no Pre-dosing 10 MBq/kg Betalutin | 1 |
| Part A, Arm 2: 15 MBq/kg Betalutin With no Pre-dosing 15 MBq/kg Betalutin | 2 |
| Part A, Arm 3: 15 MBq/kg Betalutin With Rituximab Pre-dosing 15 MBq/kg Betalutin
Rituximab | 3 |
| Part A, Arm 4: 15 MBq/kg Betalutin With Higher Dose Lilotomab Pre-dosing 15 MBq/kg Betalutin
100 mg/m2 lilotomab | 3 |
| Part A, Arm 4: 20 MBq/kg Betalutin With Higher Dose Lilotomab Pre-dosing 20 MBq/kg Betalutin
100 mg/m2 lilotomab | 19 |
| Part A, Arm 5: 20 MBq/kg Betalutin With Intermediate Dose Lilotomab Pre-dosing 20 MBq/kg Betalutin
60 mg/m2 lilotomab | 3 |
| Part A - Received Rituximab Only Participant received pre-treatment only and was withdrawn before receiving Betalutin | 2 |
| Part B Arm 1 and Part and C: 15 MBq/kg Betalutin With Lower Dose Lilotomab Pre-dosing 15 MBq/kg Betalutin
40 mg lilotomab
Note: these two groups were combined for the purposes of the safety analyses as they received the same treatment therefore have been combined for the purposes of reporting baseline variables for consistency | 76 |
| Part B, Arm 2: 20 MBq/kg Betalutin With Higher Dose Lilotomab Pre-dosing 20 MBq/kg Betalutin
100 mg/m2 lilotomab | 28 |
| Part B, Arm 3: 12.5 MBq/kg Betalutin With Lower Dose Lilotomab Pre-dosing 40 mg lilotomab
12.5 mBq/kg Betalutin | 9 |
| Part B - Received Rituximab Only Participant received pre-treatment only and was withdrawn before receiving Betalutin | 1 |
| Total | 190 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 | FG014 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Enrolled | Death | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Follow-up Period | Death | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 17 | 9 | 1 | 0 | 0 |
| Follow-up Period | Patient transferred to other hospital | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Follow-up Period | Physician Decision | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 5 | 0 | 0 | 0 | 0 |
| Follow-up Period | Progressive disease | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Follow-up Period | Sponsor Decision | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 40 | 15 | 7 | 0 | 0 |
| Follow-up Period | Start of further anticancer therapy | 4 | 25 | 2 | 1 | 2 | 2 | 1 | 15 | 2 | 0 | 0 | 0 | 0 | 0 | 0 |
| Follow-up Period | Withdrawal by Subject | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 3 | 1 | 0 | 0 | 0 |
| Pre-reatment With Rituximab | Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 |
| Pre-reatment With Rituximab | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Treatment Period With Betalutin | Death | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 |
| Treatment Period With Betalutin | Physician Decision | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 5 | 1 | 1 | 0 | 0 |
| Treatment Period With Betalutin | Progressive disease | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Treatment Period With Betalutin | Sponsor Decision | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 |
| Treatment Period With Betalutin | Start of further anticancer therapy | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 1 | 0 | 0 | 0 |
| Treatment Period With Betalutin | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Part A, Arm 1: 15 MBq/kg Betalutin With Lower Dose Lilotomab Pre-dosing | Part A, Arm 1: 20 MBq/kg Betalutin With Lower Dose Lilotomab Pre-dosing | Part A, Arm 2: 10 MBq/kg Betalutin With no Pre-dosing | Part A, Arm 2: 15 MBq/kg Betalutin With no Pre-dosing | Part A, Arm 3: 15 MBq/kg Betalutin With Rituximab Pre-dosing | Part A, Arm 4: 15 MBq/kg Betalutin With Higher Dose Lilotomab Pre-dosing | Part A, Arm 4: 20 MBq/kg Betalutin With Higher Dose Lilotomab Pre-dosing | Part A, Arm 1: 10 MBq/kg Betalutin With Lower Dose Lilotomab Pre-dosing | Part A, Arm 5: 20 MBq/kg Betalutin With Intermediate Dose Lilotomab Pre-dosing | Part A - Received Rituximab Only | Part B Arm 1 and Part and C: 15 MBq/kg Betalutin With Lower Dose Lilotomab Pre-dosing | Part B, Arm 2: 20 MBq/kg Betalutin With Higher Dose Lilotomab Pre-dosing | Part B, Arm 3: 12.5 MBq/kg Betalutin With Lower Dose Lilotomab Pre-dosing | Part B - Received Rituximab Only | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 25 Participants | 2 Participants | 1 Participants | 2 Participants | 3 Participants | 2 Participants | 15 Participants | 2 Participants | 2 Participants | 2 Participants | 47 Participants | 19 Participants | 5 Participants | 0 Participants | 127 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 4 Participants | 2 Participants | 1 Participants | 0 Participants | 29 Participants | 9 Participants | 4 Participants | 1 Participants | 63 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants | 4 Participants | 0 Participants | 0 Participants | 7 Participants |
| Race (NIH/OMB) White | 36 Participants | 3 Participants | 1 Participants | 2 Participants | 3 Participants | 3 Participants | 19 Participants | 4 Participants | 3 Participants | 2 Participants | 73 Participants | 23 Participants | 9 Participants | 1 Participants | 182 Participants |
| Sex: Female, Male Female | 19 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants | 0 Participants | 9 Participants | 1 Participants | 1 Participants | 2 Participants | 46 Participants | 16 Participants | 3 Participants | 1 Participants | 101 Participants |
| Sex: Female, Male Male | 17 Participants | 3 Participants | 1 Participants | 1 Participants | 1 Participants | 3 Participants | 10 Participants | 3 Participants | 2 Participants | 0 Participants | 30 Participants | 12 Participants | 6 Participants | 0 Participants | 89 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 2 / 4 | 10 / 36 | 0 / 3 | 0 / 1 | 0 / 2 | 2 / 3 | 2 / 3 | 6 / 18 | 1 / 4 | 0 / 2 | 23 / 76 | 11 / 28 | 1 / 9 | 0 / 1 | 1 / 1 |
| other Total, other adverse events | 3 / 4 | 36 / 36 | 3 / 3 | 0 / 1 | 2 / 2 | 3 / 3 | 3 / 3 | 16 / 18 | 4 / 4 | 2 / 2 | 61 / 76 | 22 / 28 | 9 / 9 | 1 / 1 | 0 / 1 |
| serious Total, serious adverse events | 1 / 4 | 7 / 36 | 2 / 3 | 0 / 1 | 2 / 2 | 1 / 3 | 1 / 3 | 0 / 18 | 0 / 4 | 0 / 0 | 12 / 76 | 7 / 28 | 0 / 9 | 1 / 1 | 0 / 1 |
Outcome results
Primary
Part A, Phase I
Number of participants with dose limiting toxicities (DLTs) in Part A
Time frame: 12 weeks
Population: Population evaluable for DLTs. Note one further participant was treated with 20 MBq Betalutin and 100 mg/m2 lilotomab but was underdosed with lilotomab so was not evaluable for DLTs and has not been included.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A, Arm 1: 10 MBq/kg Betalutin With Lower Dose Lilotomab Pre-dosing | Part A, Phase I | 0 Participants |
| Part A, Arm 1: 15 MBq/kg Betalutin With Lower Dose Lilotomab Pre-dosing | Part A, Phase I | 1 Participants |
| Part A, Arm 1: 20 MBq/kg Betalutin With Lower Dose Lilotomab Pre-dosing | Part A, Phase I | 3 Participants |
| Part A, Arm 2: 10 MBq/kg Betalutin With no Pre-dosing | Part A, Phase I | 0 Participants |
| Part A, Arm 2: 15 MBq/kg Betalutin With no Pre-dosing | Part A, Phase I | 2 Participants |
| Part A, Arm 3: 15 MBq/kg Betalutin With Rituximab Pre-dosing | Part A, Phase I | 1 Participants |
| Part A, Arm 4: 15 MBq/kg Betalutin With Higher Dose Lilotomab Pre-dosing | Part A, Phase I | 1 Participants |
| Part A, Arm 4: 20 MBq/kg Betalutin With Higher Dose Lilotomab Pre-dosing | Part A, Phase I | 1 Participants |
| Part A, Arm 5: 20 MBq/kg Betalutin With Intermediate Dose Lilotomab Pre-dosing | Part A, Phase I | 0 Participants |
Primary
Part A, Phase IIa
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).
Time frame: 5 years
Population: Per-protocol analysis set: participants receiving Betalutin who had adequate tumour assessments at baseline, and after ≥12 weeks (unless disease progression occurred), and no major protocol deviations impacting on efficacy results. Only participants in Phase IIa with FL receiving 40/15 and 100/20 With FL were analyzed. This was the analysis set selected for efficacy analysis as this was the population selected for further analysis in the larger Part B study.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A, Arm 1: 10 MBq/kg Betalutin With Lower Dose Lilotomab Pre-dosing | Part A, Phase IIa | Complete remission | 7 Participants |
| Part A, Arm 1: 10 MBq/kg Betalutin With Lower Dose Lilotomab Pre-dosing | Part A, Phase IIa | Partial remission | 5 Participants |
| Part A, Arm 1: 10 MBq/kg Betalutin With Lower Dose Lilotomab Pre-dosing | Part A, Phase IIa | Stable disease | 3 Participants |
| Part A, Arm 1: 10 MBq/kg Betalutin With Lower Dose Lilotomab Pre-dosing | Part A, Phase IIa | Progressive disease | 3 Participants |
| Part A, Arm 1: 15 MBq/kg Betalutin With Lower Dose Lilotomab Pre-dosing | Part A, Phase IIa | Progressive disease | 0 Participants |
| Part A, Arm 1: 15 MBq/kg Betalutin With Lower Dose Lilotomab Pre-dosing | Part A, Phase IIa | Complete remission | 2 Participants |
| Part A, Arm 1: 15 MBq/kg Betalutin With Lower Dose Lilotomab Pre-dosing | Part A, Phase IIa | Stable disease | 1 Participants |
| Part A, Arm 1: 15 MBq/kg Betalutin With Lower Dose Lilotomab Pre-dosing | Part A, Phase IIa | Partial remission | 6 Participants |
Primary
Part B, Phase IIb
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
Time frame: up to 5 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A, Arm 1: 10 MBq/kg Betalutin With Lower Dose Lilotomab Pre-dosing | Part B, Phase IIb | 28 Participants |
| Part A, Arm 1: 15 MBq/kg Betalutin With Lower Dose Lilotomab Pre-dosing | Part B, Phase IIb | 9 Participants |
| Part A, Arm 1: 20 MBq/kg Betalutin With Lower Dose Lilotomab Pre-dosing | Part B, Phase IIb | 2 Participants |