Linker Information

General Information of This Linker

Each Antibody-drug Conjugate Related to This Linker

Full Information of The Activity Data of The ADC(s) Related to This Linker

NJH-395 [Phase 1]

ADC Info

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]
Efficacy Data	Objective Response Rate (ORR)	0.00%
Patients Enrolled	Patients with nonbreast HER2+ advanced malignancies.
Administration Dosage	5 dose cohorts (0.10-1.60 mg/kg).
*Related Clinical Trial*
NCT Number	NCT03696771	Clinical Status	Phase 1
Clinical Description	A phase 1, multicenter, open-label dose finding study of NJH395, administered intravenously in patients with non-breast HER2+ advanced malignancies.

AMG-224 [Phase 1]

ADC Info

Identified from the Human Clinical Data

Click To Hide/Show 2 Activity Data Related to This Level

Experiment 1 Reporting the Activity Date of This ADC				[2]
Efficacy Data	Objective Response Rate (ORR)	23.00% (heavily pretreated population of patients with R/R MM with a median of seven lines of prior therapy) 60.00% (in a phase 1 trial of GSK2857916)
Patients Enrolled	Relapsed or refractory (R/R) multiple myeloma (MM).
Administration Dosage	Every 3 weeks (Q3W) at prespecified doses of 30-300 mg in a 3+3 design.
*Related Clinical Trial*
NCT Number	NCT02561962	Clinical Status	Phase 1
Clinical Description	A phase 1 first in human study evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of AMG 224 in subjects with relapsed or refractory multiple myeloma.
Primary Endpoint	AmG 224 was generally well tolerated up to 190 mg Q3W.
Other Endpoint	ORR=23.00% (95% CI,11.00-39.00%), including six responses in dose escalation and three responses in the dose expansion. Two (5.00%) patients were CR and 7 (18.00%) patients were PR.
Experiment 2 Reporting the Activity Date of This ADC				[3]
*Related Clinical Trial*
NCT Number	NCT02561962	Clinical Status	Phase 1
Clinical Description	A phase 1 first in human study evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of AMG 224 in subjects with relapsed or refractory multiple myeloma.

References

Ref 1	Phase Ia Study of Anti-NaPi2b Antibody-Drug Conjugate Lifastuzumab Vedotin DNIB0600A in Patients with Non-Small Cell Lung Cancer and Platinum-Resistant Ovarian Cancer. Clin Cancer Res. 2020 Jan 15;26(2):364-372. doi: 10.1158/1078-0432.CCR-18-3965.
Ref 2	Phase 1 study of the anti-BCMA antibody-drug conjugate AMG 224 in patients with relapsed/refractory multiple myeloma. Leukemia. 2021 Jan;35(1):255-258.
Ref 3	A Phase 1 First in Human Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 224 in Subjects With Relapsed or Refractory Multiple Myeloma, NCT02561962