Antibody Information
General Information of This Antibody
| Antibody ID | ANI0QYT013 |
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| Antibody Name | Idactamab |
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| Organization | AstraZeneca PLC |
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| Synonyms |
Idactamab
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| Antibody Type | Monoclonal antibody (mAb) |
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| Antigen Name | Neutral amino acid transporter B(0) (SLC1A5) |
Antigen Info | ||||
| Click to Show/Hide the Sequence Information of This Antibody | ||||||
| Heavy Chain Sequence |
QVQLQQWGAGLLKPSETLSLTCAVYGGSFSGYYWSWIRQPPGKGLEWIGEIHHSGGANYN
PSLKSRVTISVDTSKNQFSLKLSSVTAADTAVYYCARGQGKNWHYDYFDYWGQGTLVTVS S Click to Show/Hide
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| Light Chain Sequence |
DIQMTQSPSTLSASVGDRVTITCRASQSIRSWLAWYQQKPGKAPKLLIYKASILKIGVPS
RFSGSGSGTEFTLTISSLQPDDFATYYCQQYYSYSRTFGQGTKVEIK 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
MEDI7247 [Phase 1 (discontinued)]
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [1] | ||||
| Patients Enrolled |
Eligible patients must have relapsed/refractory hematologic malignancies with no standard therapies available, be ≥18 years old, ECOG 0-1, and meet organ function criteria (liver, renal). Contraception is required for sexually active participants. Exclusions include recent chemotherapy/surgery/radiotherapy, unresolved toxicities, active infections (HIV/HBV/HCV), CNS involvement, or high bleeding risk. Prior autologous SCT within 120 days or unresolved transplant-related toxicities also disqualify.
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| Administration Dosage |
The study will enroll patients with R/R AML/MM/DLBCL who will receive MEDI7247 IV
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| Related Clinical Trial | |||||
| NCT Number | NCT03106428 | Clinical Status | PHASE1 | ||
| Clinical Description |
A Phase 1 Multicenter, Open-label, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Antitumor Activity of MEDI7247 in Patients With Selected Relapsed/Refractory Hematological Malignancies
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| Primary Endpoint |
The study evaluates safety endpoints including adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs) monitored from informed consent through 90 days post-treatment. Laboratory parameters, vital signs, and ECG results are assessed for changes from baseline up to 21 days post-treatment, covering hematology, serum chemistry, coagulation, urinalysis, and cardiovascular metrics.
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| Other Endpoint |
Pharmacokinetic (PK) analysis of MEDI7247 includes maximum concentration (Cmax), area under the curve (AUC), clearance, and terminal half-life, measured from informed consent through 30 days post-treatment. Immunogenicity is assessed via anti-drug antibodies (ADAs). Anti-tumor activity is evaluated by best overall response (BOR), objective response rate (ORR), time to response (TTR), duration of response (DoR), progression-free survival (PFS), and overall survival (OS), tracked up to 3 years post-enrollment.
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| Experiment 2 Reporting the Activity Date of This ADC | [2] | ||||
| Patients Enrolled |
Eligible patients must have advanced/metastatic solid tumors refractory to standard therapies, be ≥18 years old, ECOG 0-1, and meet organ function criteria (liver, renal, hematologic). Contraception is required for sexually active participants. Exclusions include active CNS metastases (unless treated/stable), unresolved toxicities (>Grade 1), recent anticancer therapy (within 21 days), prior PBD-ADCs, high-risk cardiac conditions, active infections (HIV/HBV/HCV), pregnancy, or concurrent investigational studies. Major surgery or significant trauma within 21 days also disqualifies.
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| Administration Dosage |
Subjects with advanced solid tumors will enroll into the respective arms to receive Medi7247 IV at prescribed dose and schedule
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| Related Clinical Trial | |||||
| NCT Number | NCT03811652 | Clinical Status | PHASE1 | ||
| Clinical Description |
A Phase 1/1b Multicenter, Open-label, Dose-escalation, and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of MEDI7247 in Patients With Advanced or Metastatic Disease in Selected Solid Tumors
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| Primary Endpoint |
The study evaluates safety outcomes including adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs) monitored from informed consent through 90 days post-treatment. Laboratory parameters, vital signs, and ECG results are assessed for changes from baseline up to 90 days post-treatment, covering hematology, serum chemistry, urinalysis, and coagulation metrics.
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| Other Endpoint |
Pharmacokinetic (PK) analysis of MEDI7247 includes maximum concentration (Cmax), terminal half-life (t1/2), area under the curve (AUC), and clearance, measured from first dose through 90 days post-treatment. Immunogenicity is assessed via anti-drug antibodies (ADAs). Anti-tumor activity is evaluated by best overall response (BOR), objective response rate (ORR), time to response (TTR), duration of response (DoR), progression-free survival (PFS), disease control (DC), and overall survival (OS), tracked up to 2 years post-enrollment.
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References
