Antibody-drug Conjugate Information

General Information of This Antibody-drug Conjugate (ADC)

ADC ID	DRG0SIMLV
ADC Name	ESG-401
Synonyms	ESG 401; ESG-401; STI-3258; Humanized anti-Trop2-SN38 antibody conjugate; Humanized mAb anti-TROP-2 program Click to Show/Hide
Organization	Shanghai Escugen Biotechnology
Drug Status	Phase 1/2
Indication	In total 1 Indication(s) Solid tumors [ICD11:2A00-2A0Z\|2B50-2F9Z] Phase 2
Drug-to-Antibody Ratio	8
	3D MOL	2D MOL
Antibody Name	Sacituzumab		Antibody Info
Antigen Name	Tumor-associated calcium signal transducer 2 (TACSTD2)		Antigen Info
Payload Name	Active metabolite of irinotecan SN38		Payload Info
Therapeutic Target	DNA topoisomerase 1 (TOP1)		Target Info
Linker Name	Undisclosed
Conjugate Type	Random conjugation through reduced inter-chain cysteines.

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
Objective Response Rate (ORR)	NCT04892342	Phase 1/2	An open-label, multiple dose, dose escalation and cohort expansion phase 1/2 study to investigate the safety, tolerability, pharmacokinetics and antitumor activities of ESG401 in Subjects with locally advanced/metastatic solid tumors. Click to Show/Hide

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]
Efficacy Data	Objective Response Rate (ORR)	36.40%
Patients Enrolled	Patients (pts) aged 18 years with locally advanced/metastatic solid tumors refractory to/relapsed.
Administration Dosage	Treated with 1 dose of ESG401 during escalation at doses of 2-20 mg/kg once Q3W (Regimen A), or 12-16 mg/kg D1,8,15 in a 4-week cycle (Regimen B).
*Related Clinical Trial*
NCT Number	NCT04892342	Clinical Status	Phase 1/2
Clinical Description	An open-label, multiple dose, dose escalation and cohort expansion phase 1/2 study to investigate the safety, tolerability, pharmacokinetics and antitumor activities of ESG401 in Subjects with locally advanced/metastatic solid tumors.

References

Ref 1	Preliminary results from a first-in-human study of ESG401, a trophoblast cell-surface antigen 2 (TROP2) antibody drug conjugate (ADC), in patients with locally advanced/metastatic solid tumors. J Clin Oncol. 2023 41:16_suppl, 1100-1100.