Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0TREVJ
|
|||||
|---|---|---|---|---|---|---|
| ADC Name |
MEDI7247
|
|||||
| Synonyms |
MEDI-7247; MEDI 7247; MEDI7247
Click to Show/Hide
|
|||||
| Organization |
MedImmune (Top20 MNC)
|
|||||
| Drug Status |
Phase 1 (discontinued)
|
|||||
| Drug-to-Antibody Ratio |
2
|
|||||
| Structure |
|
|||||
|
|
||||||
| Antibody Name |
Idactamab
|
Antibody Info | ||||
| Antigen Name |
Amino acid transporter (ASCT2)
|
Antigen Info | ||||
| Payload Name |
SG3199 (SC-DR002)
|
Payload Info | ||||
| Therapeutic Target |
Human deoxyribonucleic acid (hDNA)
|
Target Info | ||||
| Linker Name |
Mal-PEG8-Val-Ala-PABC
|
Linker Info | ||||
| Conjugate Type |
Reactive Cysteines
|
|||||
| Combination Type |
tesirine
|
|||||
The indication landscape of This ADC(2027 Update)
The clinical trial pipeline of This ADC(2027 Update)
| Indication | Phase 1 | Phase 1/2 | Phase 2 | Phase 2/3 | Phase 3 | New Drug Application | Approved | ||
|---|---|---|---|---|---|---|---|---|---|
| Acute myeloid leukaemia |
1 Trials
|
||||||||
| Colorectal cancer |
1 Trials
|
||||||||
| Diffuse large b-cell lymphoma |
1 Trials
|
||||||||
| Head and neck cancer |
1 Trials
|
||||||||
| Lung cancer |
1 Trials
|
||||||||
| Multiple myeloma |
1 Trials
|
||||||||
| Pancreatic cancer |
1 Trials
|
||||||||
| Prostate cancer |
1 Trials
|
||||||||
| Unspecific solid tumor |
1 Trials
|
General Information of The Activity Data Related to This ADC
Identified from the Human Clinical Data
Full List of Activity Data of This Antibody-drug Conjugate
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.
Click to Show/Hide
|
||||
| Administration Dosage |
The study will enroll patients with R/R AML/MM/DLBCL who will receive MEDI7247 IV
|
||||
| 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 | ||||
| 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.
Click to Show/Hide
|
||||
| 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.
Click to Show/Hide
|
||||
| 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.
Click to Show/Hide
|
||||
| Administration Dosage |
Subjects with advanced solid tumors will enroll into the respective arms to receive Medi7247 IV at prescribed dose and schedule
|
||||
| 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 | ||||
| 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.
Click to Show/Hide
|
||||
| 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.
Click to Show/Hide
|
||||
References
