Antibody Information
General Information of This Antibody
| Antibody ID | ANI0VELIR |
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| Antibody Name | Lorvotuzumab |
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| Organization | ImmunoGen, Inc. |
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| Indication | Wilms tumor |
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| Synonyms |
huN901
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| Antibody Type | Monoclonal antibody (mAb) |
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| Antibody Subtype | Humanized IgG1-kappa |
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| Antigen Name | Neural cell adhesion molecule 1 (NCAM1) |
Antigen Info | ||||
| Click to Show/Hide the Sequence Information of This Antibody | ||||||
| Heavy Chain Sequence |
QVQLVESGGGVVQPGRSLRLSCAASGFTFSSFGMHWVRQAPGKGLEWVAYISSGSFTIYY
ADSVKGRFTISRDNSKNTLYLQMNSLRAEDTAVYYCARMRKGYAMDYWGQGTLVTVSSAS TKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGL YSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGGPS VFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNST YRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSRDELT KNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQ GNVFSCSVMHEALHNHYTQKSLSLSPGK Click to Show/Hide
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| Light Chain Sequence |
DVVMTQSPLSLPVTLGQPASISCRSSQIIIHSDGNTYLEWFQQRPGQSPRRLIYKVSNRF
SGVPDRFSGSGSGTDFTLKISRVEAEDVGVYYCFQGSHVPHTFGQGTKVEIKRTVAAPSV FIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSL SSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC Click to Show/Hide
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Each Antibody-drug Conjugate Related to This Antibody
Full Information of The Activity Data of The ADC(s) Related to This Antibody
Lorvotuzumab mertansine [Phase 2 (discontinued)]
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [1] | ||||
| Patients Enrolled |
Eligible patients include adults (≥18) with CD56+ hematologic malignancies (AML, high-risk MDS, NK leukemia, ALL, CML blast phase, MF, or BPDCN) refractory to prior therapies, ECOG ≤2, adequate organ function, and proper contraception. Exclusions: IMGN901 allergy/hypersensitivity, active CNS disease, grade ≥3 neuropathy, uncontrolled cardiac/pulmonary/pancreatic conditions, recent major surgery, pregnancy, or protocol non-compliance. Reproductive-age participants must use dual contraception.
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| Administration Dosage |
100 mg/m2 by vein on Day 1 and 8 of a 21-day cycle.
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| Related Clinical Trial | |||||
| NCT Number | NCT02420873 | Clinical Status | PHASE2 | ||
| Clinical Description |
An Open-label Phase II Study of Lorvotuzumab Mertansine (IMGN901) in CD56 Expressing Hematological Malignancies
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| Primary Endpoint |
The primary endpoint is Overall Response Rate (ORR) to IMGN901 in CD56+ hematological malignancies, defined as Complete Remission (CR + CRp + CRi) achieved within three cycles (53-day evaluation).
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| Other Endpoint |
Secondary data collection focuses on safety monitoring but specific endpoints were not predefined in the provided information.
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| Experiment 2 Reporting the Activity Date of This ADC | [2] | ||||
| Patients Enrolled |
Eligible patients must have histologically confirmed, relapsed/refractory CD56+ multiple myeloma (≥1 prior therapy, ≤6 regimens at MTD). Key inclusion: ECOG 0-2, adequate organ function, life expectancy ≥12 weeks, no severe neuropathy, cardiac disease, pancreatitis, or active infections. Exclusion: recent stroke, malignancies (except certain in situ cancers), uncontrolled comorbidities, or prior hypersensitivity to monoclonal antibodies. Prior therapy washout: ≥4 weeks for chemo/RT/surgery, ≥2 weeks for biologics. Concurrent bisphosphonates allowed if stable; steroids restricted to specific indications.
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| Administration Dosage |
dose escalation study, doses will vary per cohort. patients will receive an IV infusion weekly for two weeks every three weeks.
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| Related Clinical Trial | |||||
| NCT Number | NCT00346255 | Clinical Status | PHASE1 | ||
| Clinical Description |
A Phase I Study to Assess The Safety and Pharmacokinetics of BB-10901 (huN901-DM1) Given as an Intravenous Infusion Weekly for Two Consecutive Weeks Every Three Weeks to Subjects With Relapsed and Relapsed Refractory CD56-Positive Multiple Myeloma
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| Primary Endpoint |
This study evaluates dose-limiting toxicity (through cycle 1) and maximum tolerated dose (for the duration of the study).
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| Other Endpoint |
Assessed endpoints include qualitative/quantitative toxicities, pharmacokinetics, and anti-tumor activity (response rate, progression-free survival, overall survival), all measured for the duration of the study.
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| Experiment 3 Reporting the Activity Date of This ADC | [3] | ||||
| Patients Enrolled |
Eligible patients must be ≥18 years, have ECOG ≤2, meet CD56-positive criteria, and have received 1-3 prior regimens (including lenalidomide/bortezomib if applicable). Exclusions include active infections, significant cardiac disease, recent chemotherapy/radiation, neuropathy ≥grade 2, or inadequate organ function (ANC ≥1000, platelets ≥50K, creatinine ≤1.5x ULN). Strict contraception and compliance with RevAssist® are mandated.
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| Administration Dosage |
dose escalation study. dosing on days 1, 8 and 15 every 28 days
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| Related Clinical Trial | |||||
| NCT Number | NCT00991562 | Clinical Status | PHASE1 | ||
| Clinical Description |
An Open-Label Phase I Study of Bb-10901 (IMGN901, huN901-DM10 in Combination With Lenalidomide and Dexamethasone in Patients With CD56-positive Relapsed or Relapsed/Refractory Multiple Myeloma
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| Primary Endpoint |
The study aims to determine the MTD/RPTD and assess the response rate of the combination therapy in patients with CD56-positive relapsed/refractory multiple myeloma, evaluating efficacy through objective response rate, duration of responses, progression-free survival, and overall survival.
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| Other Endpoint |
Key pharmacodynamic outcomes and safety parameters, including ORR, CR rates, time to progression, and survival metrics, will be monitored throughout the study duration.
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| Experiment 4 Reporting the Activity Date of This ADC | [4] | ||||
| Patients Enrolled |
Eligible patients (age ≥1, Karnofsky/Lansky ≥50) must have measurable disease (exceptions: MIBG-avid neuroblastoma), prior standard therapy, and adequate organ function (ANC ≥750-1000/uL, platelets ≥75K-100K/uL, GFR ≥70 mL/min). Exclusions include active CNS metastases, neuropathy ≥grade 2, uncontrolled infections, recent chemotherapy (<3 weeks), pregnancy, or prior IMGN901 exposure. Reproductive-age participants must use contraception.
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| Administration Dosage |
Patients receive lorvotuzumab mertansine IV over 1-1.5 hours on days 1 and 8. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
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| Related Clinical Trial | |||||
| NCT Number | NCT02452554 | Clinical Status | PHASE2 | ||
| Clinical Description |
A Phase 2 Study of IMGN901 (Lorvotuzumab Mertansine; NSC#: 783609) in Children With Relapsed or Refractory Wilms Tumor, Rhabdomyosarcoma, Neuroblastoma, Pleuropulmonary Blastoma, Malignant Peripheral Nerve Sheath Tumor (MPNST) and Synovial Sarcoma
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| Primary Endpoint |
The study evaluates objective response rates (ORR) per RECIST v1.1 in pediatric/adolescent solid tumors (Wilms tumor, rhabdomyosarcoma, neuroblastoma, and other CD56+ malignancies), assessing partial/complete responses over 18 weeks. Toxicity profiles of lorvotuzumab mertansine will be monitored via NCI CTCAE v4.0 for 12 months.
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| Other Endpoint |
Key endpoints focus on response stratification and safety, with Clopper-Pearson confidence intervals for ORR and detailed toxicity summaries by cycle and attribution.
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| Experiment 5 Reporting the Activity Date of This ADC | [5] | ||||
| Patients Enrolled |
Eligible patients were ≥18 years with untreated extensive-stage SCLC (ECOG 0-2). Exclusion criteria included pregnancy/lactation and prior SCLC chemotherapy. The control arm served primarily for safety validation rather than powered efficacy comparisons.
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| Administration Dosage |
Phase 2 regimen is IMGN901, Carboplatin, and Etoposide. IMGN901 to be given on days 1 and 8 every 21 days.
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| Related Clinical Trial | |||||
| NCT Number | NCT01237678 | Clinical Status | PHASE1|||PHASE2 | ||
| Clinical Description |
A Phase 1/2 Study to Assess the Safety and Efficacy of Lorvotuzumab Mertansine in Combination With Carboplatin/Etoposide in Patients With Advanced Solid Tumors Including Extensive Stage Small Cell Lung Cancer
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| Primary Endpoint |
The primary Phase I objective was determining the MTD of IMGN901 in combination with carboplatin/etoposide for solid tumors, with DLTs assessed during Cycle 1 (21 days), including febrile neutropenia, grade ≥3 toxicities, and treatment-delaying events. Phase II focused on PFS in extensive-stage SCLC patients comparing the IMGN901 triplet regimen against historical carboplatin/etoposide controls.
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| Other Endpoint |
Safety profiles were evaluated through TEAEs/SAEs (CTCAE v4.0-graded) until 28 days post-treatment. Secondary efficacy metrics included 6-month PFS rates (experimental arm vs historical 44% benchmark) and median OS, though statistical comparisons were limited by study design.
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| Experiment 6 Reporting the Activity Date of This ADC | [6] | ||||
| Patients Enrolled |
Prior therapy restrictions: ≤3 chemotherapy lines (ovarian patients require platinum exposure), no recent radiotherapy/immunotherapy (4-week washout), and anthracycline doses below cardiotoxicity thresholds. Concurrent antineoplastic treatments are prohibited.
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| Administration Dosage |
dose escalation study, dose will vary per cohort. patients will receive an IV infusion once every three weeks.
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| Related Clinical Trial | |||||
| NCT Number | NCT00346385 | Clinical Status | PHASE1 | ||
| Clinical Description |
A Phase I, Open-Label, Dose Escalation Study of Daily Dosing With BB-10901
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| Primary Endpoint |
Safety and pharmacokinetic assessments will evaluate toxicity (via prothrombin time tests) and IMGN901 conjugate/antibody levels during Cycle 1 (21 days), while efficacy focuses on tumor response rates and neuroendocrine biomarkers (neuron-specific enolase/NCAM) measured every 2 cycles.
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| Other Endpoint |
Eligible patients (ECOG 0-2, life expectancy ≥3 months) include relapsed/refractory SCLC (1-3 prior regimens), CD56+ neuroendocrine tumors, and select carcinomas (Merkel cell/ovarian). Key exclusions: uncontrolled metastases, significant cardiorespiratory comorbidities, active infections, or pancreatitis risk factors (elevated LFTs/pancreatic enzymes).
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| Experiment 7 Reporting the Activity Date of This ADC | [7] | ||||
| Efficacy Data | Objective Response Rate (ORR) |
28.30%
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Positive CD56 expression (CD56+++/++) | ||
| Patients Enrolled |
Relapsed and/or Refractory CD-56-positive Multiple Myeloma.
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| Administration Dosage |
40 mg/m2 (up to a maximum of 140 mg) intravenously once every 3 weeks.
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| Related Clinical Trial | |||||
| NCT Number | NCT00346255 | Clinical Status | Phase 1 | ||
| Clinical Description |
BB-10901 in treating patients with relapsed and/or refractory multiple myeloma (IMGN901).
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| Primary Endpoint |
Objective response rate=28.30%.
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| Other Endpoint |
Median progression-free survival=26.10 months (95% CI 1-89 weeks).
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References