Antibody-drug Conjugate Information

General Information of This Antibody-drug Conjugate (ID: DRG0NDFLP)
ADC Name
DCD133KDEL
Synonyms
DCD133KDEL; OXS 1650; OXS-1650
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Organization
University of Minnesota; GT Biopharma, Inc.
Drug Status
Phase 1 (discontinued)
Antibody Name
Undisclosed
Antigen Name
Prominin-1 (PROM1)
  Antigen Info 
Payload Name
Pseudomonas exotoxin PE38
  Payload Info 
Linker Name
Undisclosed
2027 Update
The disease landscape of This ADC
2027 Update
The clinical trial pipelines of This ADC
Disease Name Phase 1 Phase 2 Phase 3 Approved
Unspecific solid tumor
1 Trials
Clinical trial identifier
NCT02845414
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  NCT02845414
PHASE1
Phase I Study Of Stem-Cell Directed Deimmunized CD133KDEL Toxin In The Treatment Of Solid Tumors
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 must have metastatic/unresectable solid tumors (measurable per RECIST 1.1), ≥1 prior systemic therapy, ECOG 0-1, and adequate organ function. Key exclusions include active CNS metastases (unless stable post-radiation), uncontrolled cardiac conditions, prior toxin-directed therapy, or hypersensitivity to dCD133KDEL components. Women of childbearing potential must use dual contraception.

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Administration Dosage
Patients will receive dCD133KDEL at the assigned dose level via a 30-minute intravenous infusion on days 1, 3, 5, 8, 10 and 12 (total of 6 doses) of a 28-day cycle.
Related Clinical Trial
NCT Number NCT02845414  Clinical Status PHASE1
Clinical Description Phase I Study Of Stem-Cell Directed Deimmunized CD133KDEL Toxin In The Treatment Of Solid Tumors
Primary Endpoint
The primary objective is to determine the maximum tolerated dose (MTD) of dCD133KDEL by Day 28, with dose-limiting toxicities (DLTs) defined as ≥Grade 3 adverse events (CTCAE v4.0) within 21 days post-first dose that are possibly treatment-related.
Other Endpoint
Secondary objectives include tumor response assessment per RECIST 1.1 criteria (evaluated between Days 29-33 and every 6-12 weeks thereafter), with responses summarized by dose level including 95% confidence intervals.
References
Ref 1 Study of CD133KDEL Toxin in the Treatment for Solid Tumors