General Information of This Antibody-drug Conjugate (ADC)
ADC ID
DRG0WIBDT
ADC Name
Pamlectabart tismanitin
Synonyms
pamlectabart tismanitin; HDP-101; HDM2027
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Organization
Heidelberg Pharma (Originator);Huadong Medicine
Drug Status
Phase 1/2
Drug-to-Antibody Ratio
2
Structure
Antibody Name
Pamlectabart
 Antibody Info 
Antigen Name
Tumor necrosis factor receptor superfamily member 17 (TNFRSF17)
 Antigen Info 
Payload Name
HDP 30.2115
 Payload Info 
Therapeutic Target
RNA polymerase II
 Target Info 
Linker Name
Mal-Val-Ala-PAB
 Linker Info 
Conjugate Type
Reactive Cysteines
Combination Type
tismanitin
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
Multiple myeloma
1 Trials
Trial ID
CTR20260193
1 Trials
Trial ID
NCT04879043; EudraCT2020-003414-12; EUCT2024-515273-10-00
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  NCT04879043
PHASE1|||PHASE2
A Phase 1/2a, First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of HDP-101 in Patients With Plasma Cell Disorders Including Multiple Myeloma
Revealed Based on the Cell Line Data
Click To Hide/Show 11 Activity Data Related to This Level
Standard Type Value Units Cell Line Disease Model
Half Maximal Inhibitory Concentration (IC50) 
0.01
nM
U266B1 cells
Plasma cell myeloma
Half Maximal Inhibitory Concentration (IC50) 
0.04
nM
NCI-H929 cells
Plasma cell myeloma
Half Maximal Inhibitory Concentration (IC50) 
0.16
nM
MM1.S cells
Plasma cell myeloma
Half Maximal Inhibitory Concentration (IC50) 
0.18
nM
INA-6 cells
Plasma cell myeloma
Half Maximal Inhibitory Concentration (IC50) 
0.3
nM
LP-1 cells
Plasma cell myeloma
Half Maximal Inhibitory Concentration (IC50) 
0.34
nM
SK-MM-1 cells
Multiple myeloma
Half Maximal Inhibitory Concentration (IC50) 
4.83
nM
L-363 cells
Plasma cell myeloma
Half Maximal Inhibitory Concentration (IC50) 
34.2
nM
OPM-2 cells
Plasma cell myeloma
Half Maximal Inhibitory Concentration (IC50) 
142
nM
RPMI-8226 cells
Plasma cell myeloma
Half Maximal Inhibitory Concentration (IC50) 
> 1000
nM
U2OS cells
Osteosarcoma
Half Maximal Inhibitory Concentration (IC50) 
> 1000
nM
HS-5 cells
Normal
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
Eligibility requires adults (&ge;18) with IMWG-defined active MM after &ge;3 prior lines (IMiD/PI/anti-CD38) who are transplant-ineligible/post-SCT, excluding those with plasma cell leukemia, active CNS/other malignancies, uncontrolled infections (HIV/HBV/HCV), or recent SCT/radiotherapy (<12/<21 weeks). Phase 2a specifically excludes prior BCMA-targeted therapy exposure.

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Administration Dosage
Participants will receive HDP-101 intravenously in a 21 day cycle until disease progression, intolerable toxicity, Investigator's discretion or patient withdrawal.During the phase 1 tolerability of different dose levels will be evaluated. During the phase 2a dose expansion part the recommended phase 2 dose (RP2D) of HDP-101 will be administered.
Related Clinical Trial
NCT Number NCT04879043  Clinical Status PHASE1|||PHASE2
Clinical Description A Phase 1/2a, First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of HDP-101 in Patients With Plasma Cell Disorders Including Multiple Myeloma
Primary Endpoint
Primary endpoints evaluate safety (dose-limiting toxicities during first 21-day cycle) and efficacy (objective response rate per IMWG criteria including sCR/CR/VGPR/PR) in relapsed/refractory multiple myeloma patients over approximately 1 year.
Other Endpoint
Secondary objectives include comprehensive safety assessment (CTCAE v5.0 graded AEs) and clinical activity measures (PFS/OS) to characterize HDP-101's therapeutic profile, with all endpoints monitored throughout the 1-year study duration.
Revealed Based on the Cell Line Data
Click To Hide/Show 11 Activity Data Related to This Level
Experiment 1 Reporting the Activity Date of This ADC [2]
Efficacy Data Half Maximal Inhibitory Concentration (IC50)
0.01 nM
Method Description
The inhibitory activity of HDP-101 against cancer cell growth was evaluated in various human cancer cell lines in vitro. The cells were treated 2 or 4 days.
In Vitro Model Plasma cell myeloma U266B1 cells CVCL_0566
Experiment 2 Reporting the Activity Date of This ADC [2]
Efficacy Data Half Maximal Inhibitory Concentration (IC50)
0.04 nM
Method Description
The inhibitory activity of HDP-101 against cancer cell growth was evaluated in various human cancer cell lines in vitro. The cells were treated 2 or 4 days.
In Vitro Model Plasma cell myeloma NCI-H929 cells CVCL_1600
Experiment 3 Reporting the Activity Date of This ADC [2]
Efficacy Data Half Maximal Inhibitory Concentration (IC50)
0.16 nM
Method Description
The inhibitory activity of HDP-101 against cancer cell growth was evaluated in various human cancer cell lines in vitro. The cells were treated 2 or 4 days.
In Vitro Model Plasma cell myeloma MM1.S cells CVCL_8792
Experiment 4 Reporting the Activity Date of This ADC [2]
Efficacy Data Half Maximal Inhibitory Concentration (IC50)
0.18 nM
Method Description
The inhibitory activity of HDP-101 against cancer cell growth was evaluated in various human cancer cell lines in vitro. The cells were treated 2 or 4 days.
In Vitro Model Plasma cell myeloma INA-6 cells CVCL_5209
Experiment 5 Reporting the Activity Date of This ADC [2]
Efficacy Data Half Maximal Inhibitory Concentration (IC50)
0.3 nM
Method Description
The inhibitory activity of HDP-101 against cancer cell growth was evaluated in various human cancer cell lines in vitro. The cells were treated 2 or 4 days.
In Vitro Model Plasma cell myeloma LP-1 cells CVCL_0012
Experiment 6 Reporting the Activity Date of This ADC [2]
Efficacy Data Half Maximal Inhibitory Concentration (IC50)
0.34 nM
Method Description
The inhibitory activity of HDP-101 against cancer cell growth was evaluated in various human cancer cell lines in vitro. The cells were treated 2 or 4 days.
In Vitro Model Multiple myeloma SK-MM-1 cells CVCL_A478
Experiment 7 Reporting the Activity Date of This ADC [2]
Efficacy Data Half Maximal Inhibitory Concentration (IC50)
4.83 nM
Method Description
The inhibitory activity of HDP-101 against cancer cell growth was evaluated in various human cancer cell lines in vitro. The cells were treated 2 or 4 days.
In Vitro Model Plasma cell myeloma L-363 cells CVCL_1357
Experiment 8 Reporting the Activity Date of This ADC [2]
Efficacy Data Half Maximal Inhibitory Concentration (IC50)
34.2 nM
Method Description
The inhibitory activity of HDP-101 against cancer cell growth was evaluated in various human cancer cell lines in vitro. The cells were treated 2 or 4 days.
In Vitro Model Plasma cell myeloma OPM-2 cells CVCL_1625
Experiment 9 Reporting the Activity Date of This ADC [2]
Efficacy Data Half Maximal Inhibitory Concentration (IC50)
142 nM
Method Description
The inhibitory activity of HDP-101 against cancer cell growth was evaluated in various human cancer cell lines in vitro. The cells were treated 2 or 4 days.
In Vitro Model Plasma cell myeloma RPMI-8226 cells CVCL_0014
Experiment 10 Reporting the Activity Date of This ADC [2]
Efficacy Data Half Maximal Inhibitory Concentration (IC50) > 1000 nM
Method Description
The inhibitory activity of HDP-101 against cancer cell growth was evaluated in various human cancer cell lines in vitro. The cells were treated 2 or 4 days.
In Vitro Model Osteosarcoma U2OS cells CVCL_0042
Experiment 11 Reporting the Activity Date of This ADC [2]
Efficacy Data Half Maximal Inhibitory Concentration (IC50) > 1000 nM
Method Description
The inhibitory activity of HDP-101 against cancer cell growth was evaluated in various human cancer cell lines in vitro. The cells were treated 2 or 4 days.
In Vitro Model Normal HS-5 cells CVCL_3720
References
Ref 1 Study to Assess Safety of HDP-101 in Patients With Relapsed Refractory Multiple Myeloma
Ref 2 HDP-101, an Anti-BCMA Antibody-Drug Conjugate, Safely Delivers Amanitin to Induce Cell Death in Proliferating and Resting Multiple Myeloma Cells. Mol Cancer Ther. 2021 Feb;20(2):367-378.