General Information of This Antibody-drug Conjugate (ADC)
ADC ID
DRG0TAJWU
ADC Name
INA03
Synonyms
INA03
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Organization
Inatherys (Originator);Syndivia (Originator)
Drug Status
Phase 1
Structure
Antibody Name
Anti-CD71 mAb
 Antibody Info 
Antigen Name
Transferrin receptor protein 1 (TFRC)
 Antigen Info 
Payload Name
MMAE
 Payload Info 
Therapeutic Target
Microtubule (MT)
 Target Info 
Linker Name
APN-PEG5-Val-Cit-PABC
 Linker Info 
Conjugate Type
Undisclosed
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 lymphoblastic leukemia
1 Trials
Trial ID
NCT03957915; EudraCT2019-000814-13; EUCT2024-518265-10-01
Acute myeloid leukaemia
1 Trials
Trial ID
NCT03957915; EudraCT2019-000814-13; EUCT2024-518265-10-01
Mixed phenotype acute leukaemia
1 Trials
Trial ID
NCT03957915; EudraCT2019-000814-13; EUCT2024-518265-10-01
General Information of The Activity Data Related to This ADC
Identified from the Human Clinical Data
Click To Hide/Show 1 Activity Data Related to This Level
Standard Type NCT Number Clinical Status Clinical Trial Description
Undisclosed  NCT03957915
EARLY_PHASE1
A Phase I, First in Human, Open-label Study of Escalating Doses of INA03 Administered Intravenously as Single Agent in Adult Patients With Relapse/Refractory Acute Leukemia
Full List of Activity Data of This Antibody-drug Conjugate
Identified from the Human Clinical Data
Click To Hide/Show 1 Activity Data Related to This Level
Experiment 1 Reporting the Activity Date of This ADC [1]
Patients Enrolled
Eligible patients include adults (&ge;18 years) with relapsed/refractory ALL, AML, or MPAL (WHO 2016, CD71+ &ge;20% blasts), controlled blast count (<20,000/mm <sup>3</sup>), adequate organ function, and ECOG 0-2. Exclusions cover APL, prior anti-TfR therapy, recent transplant, CNS disease, uncontrolled cardiac/liver disease, active infection, pregnancy, and major surgery within 4 weeks.

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Administration Dosage
INA03 will be administered IV on Day 1, Day 14 of 28-day cycles. The administration of INA03 will begin at 0.02 mg/kg. Study Part I is a titration study to determine the dose for the first INA03 infusion. Patients will be enrolled in sequential cohorts of 2 patients to receive ascending starting doses of INA03, starting from the lowest starting dose (0.02 mg/kg), and followed by subsequent administrations of INA03 (D14 and beyond) at a fixed dose of 0.1 mg/kg. The starting dose will be increased every cohort of 2 patients until evidence of absence of marrow residual erythroblasts by D14 myelogram. This dose is referred to as the MEID and will be selected as the D1 dose for the study Part 2. Patient accumulation in Part I of the study will continue until no evidence of non-hematological DLT within 28 days post dosing

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Related Clinical Trial
NCT Number NCT03957915  Clinical Status EARLY_PHASE1
Clinical Description A Phase I, First in Human, Open-label Study of Escalating Doses of INA03 Administered Intravenously as Single Agent in Adult Patients With Relapse/Refractory Acute Leukemia
Primary Endpoint
The study assesses the minimal erythroblastopenia-inducing dose (MEID) of INA03 in adults with refractory/relapsed acute leukemia within 2 weeks post-dose, defined by erythroblast depletion or Grade ≥2 non-hematologic toxicity, followed by determining the maximum tolerated dose (MTD) for subsequent administrations (Day 15 onwards) over 28 days.
Other Endpoint
Safety is evaluated via NCI-CTCAE v5.0-graded adverse events. Pharmacokinetic analysis includes Cmax, AUC, and half-life (t½) from dosing to Day 42, while pharmacodynamics tracks erythroblast/blast reduction via bone marrow aspirates. Anti-INA03 antibodies are measured, and preliminary efficacy is assessed per ELN 2017 criteria for up to 182 days.

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References
Ref 1 Study of Escalating Doses of INA03 Administered Intravenously as Single Agent in Adult Patients With Relapse/Refractory Acute Leukemia