Antibody-drug Conjugate Information

General Information of This Antibody-drug Conjugate (ADC)

ADC ID	DRG0ENYRQ
ADC Name	DB-1303
Synonyms	DB1303; DB 1303 Click to Show/Hide
Organization	Duality Biologics; BioNTech SE
Drug Status	Phase 1/2
Indication	In total 1 Indication(s) HER2(+) solid tumors [ICD11:2A00-2A0Z\|2B50-2F9Z] Phase 2
Drug-to-Antibody Ratio	8
Structure
	3D MOL	2D MOL
Antibody Name	Undisclosed
Antigen Name	Receptor tyrosine-protein kinase erbB-2 (ERBB2)		Antigen Info
Payload Name	P1003		Payload Info
Therapeutic Target	DNA topoisomerase 1 (TOP1)		Target Info
Linker Name	Mc-Gly-Gly-Phe-Gly		Linker Info
Conjugate Type	Random conjugation through reduced inter-chain cysteines.
Special Approval(s)	Fast track(FDA)

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)	NCT05150691	Phase 1/2	A phase 1/2a, multicenter, open-label, non-randomized first in human study to assess the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of DB-1303 in patients with 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)	44.20 50.00% (HER2-positive BC) 38.50% (HER2-Low BC) 66.70% (CRC) 50.00% (EsC) 50.00% (OC) 33.30% (EC)
Patients Enrolled	Pretreated advanced or metastatic solid tumors; Histologically confirmed HER2-positive or HER2- expressing cancers.
Administration Dosage	2.20 - 12.00 mg/kg Q3W.
*Related Clinical Trial*
NCT Number	NCT05150691	Clinical Status	Phase 1/2
Clinical Description	A phase 1/2a, multicenter, open-label, non-randomized first in human study to assess the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of DB-1303 in patients with advanced/metastatic solid tumors.

References

Ref 1	A Phase 1/2a, multicenter, open-label, non-randomized first-in-human study to assess the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of DB-1303 in patients with advanced/metastatic solid tumors. Cancer Res (2023) 83 (8_Supplement): CT247.