Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ID: DRG0QDSYX)
| ADC Name |
HDM-2005
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| Synonyms |
HDM-2005; HDM 2005; HDM2005
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| Organization |
Huadong Medicine Co., Ltd.
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| Drug Status |
Phase 1
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| Antibody Name |
Undisclosed
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| Antigen Name |
Inactive tyrosine-protein kinase transmembrane receptor ROR1 (ROR1)
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Antigen Info | ||||
| Payload Name |
Undisclosed
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| Linker Name |
Undisclosed
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2027 Update
The disease landscape of This ADC
2027 Update
The clinical trial pipelines of This ADC
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 |
Inclusion: Signed consent, age ≥18, ECOG 0-2 (lymphoma) or 0-1 (solid tumors), life expectancy ≥3 months, measurable lesions, adequate organ function, contraception use. Exclusion: CNS/brain metastases, GVHD ≥G2, active infections, uncontrolled effusions, severe comorbidities, pregnancy, or conditions compromising study integrity per investigator judgment.
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| Administration Dosage |
In dose escalation phase, participants will be administered escalating doses of HDM2005 at 0.3~2.75mg/kg IV on Day 1 of repeated 21-day cycles.
In dose expansion phase, participants will be administered to recommended dose for expansion (RDE) of HDM2005 on Day 1 of repeated 21-day cycles .
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| Related Clinical Trial | |||||
| NCT Number | NCT06615193 | Clinical Status | PHASE1 | ||
| Clinical Description | A Phase Ia/Ib, Open-label, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HDM2005 in Patients With Relapsed/Refractory B-cell Lymphoma and Advanced Solid Tumor | ||||
| Primary Endpoint |
The dose escalation phase evaluates DLT incidence (21-day post-first dose) and AE severity (28-day post-last dose) per NCI CTCAE v5.0. The expansion phase assesses ORR (CR/PR, up to 3.5 years) and RP2D determination based on safety, PK, exposure-response, and efficacy data.
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| Other Endpoint |
Pharmacokinetics include plasma concentrations of HDM2005, total antibody, and free MMAE (28-day post-last dose). Immunogenicity measures ADA-positive patients. Safety (AE monitoring) and efficacy endpoints (ORR, TTR, PFS, DOR, OS) are tracked for both phases over ~3.5 years.
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References