Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0HGNSO
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| ADC Name |
ADRX-0405
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| Synonyms |
ADRX-0405
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| Organization |
Adcentrx Therapeutics (Originator)
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| Drug Status |
Phase 1
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| Drug-to-Antibody Ratio |
8
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| Antibody Name |
Anti-STEAP1 antibody
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Antibody Info | ||||
| Antigen Name |
Metalloreductase STEAP1 (STEAP1)
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Antigen Info | ||||
| Payload Name |
AP052
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Payload Info | ||||
| Therapeutic Target |
Microtubule (MT)
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Target Info | ||||
| Linker Name |
A cleavable linker
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Linker Info | ||||
| Conjugate Type |
Undisclosed
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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 | ||
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| Gastric cancer |
1 Trials
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| Lung cancer |
1 Trials
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| Prostate cancer |
1 Trials
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General Information of The Activity Data Related to This ADC
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 |
Key eligibility comprises Phase 1a patients with advanced mCRPC/GC/NSCLC and Phase 1b with castration-resistant prostate cancer (testosterone <50ng/dL) failing SOC therapies, requiring measurable disease (RECIST 1.1 or PCWG3) and ECOG 0-1/0-2 status. Major exclusions include active CNS metastases, significant CVD, recent malignancies (<3 years), current ILD/pneumonitis, or active infections (prophylaxis allowed).
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| Administration Dosage |
Increasing doses of ADRX-0405 will be administered to identify the maximum tolerated dose (MTD) and the recommended dose to be used in the Phase 1b part.
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| Related Clinical Trial | |||||
| NCT Number | NCT06710379 | Clinical Status | PHASE1 | ||
| Clinical Description | A Phase 1a/b Study of ADRX-0405 in Subjects with Select Advanced Solid Tumors | ||||
| Primary Endpoint |
Primary safety evaluation focuses on adverse event monitoring throughout the 2-year study period for ADRX-0405 in advanced solid tumors including mCRPC, GC, and NSCLC, particularly in treatment-resistant mCRPC cases.
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| Other Endpoint |
econdary assessments include comprehensive PK profiling (Ceoi/Cmax, Ctrough, AUC, t1/2, CL, Vss), immunogenicity (ADA incidence), and efficacy metrics (ORR by RECIST 1.1/PCWG3, DOR, DCR, PFS, rPFS, OS) all measured over the 2-year study duration.
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