Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0QDSYX
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| 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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| Therapeutic Target |
Stimulator of interferon genes protein (STING1)
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Target Info | ||||
| Linker Name |
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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| Hematological malignancies |
1 Trials
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| Lymphoma |
1 Trials
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| Unspecific solid tumor |
1 Trials
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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