Antibody-drug Conjugate Information

General Information of This Antibody-drug Conjugate (ADC)

ADC ID	DRG0NDFLP
ADC Name	DCD133KDEL
Synonyms	DCD133KDEL; OXS 1650; OXS-1650 Click to Show/Hide
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
Therapeutic Target	Eukaryotic elongation factor 2 kinase (EEF2K)	Target Info
Linker Name	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

Unspecific solid tumor

1 Trials

Trial ID
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. Click to Show/Hide
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