ADC Name	AbGn-107
Synonyms	AbGn-107    Click to Show/Hide
Organization	AltruBio (Originator)
Drug Status	Phase 1 (discontinued)
Drug-to-Antibody Ratio	2.5
Antibody Name	Anti-AbGn-7 antibody					Antibody Info
Antigen Name	AbGn-7 antigen					Antigen Info
Payload Name	DM4					Payload Info
Payload Target	Microtubule (MT)					Target Info
Linker Name	Val-Cit dipeptide linker					Linker Info
Conjugate Type	Random Cysteines

Standard Type	Value	Units	Description	Reference
Maximum Observed Concentration (Cmax)	2.09	ug/mL	Summary of pharmacokinetic parameters of AbGn-107 analytes following 0.1mg/kg, Q4W.	[1]
Maximum Observed Concentration (Cmax)	3.39	ug/mL	Summary of pharmacokinetic parameters of AbGn-107 analytes following 0.2 mg/kg, Q4W.	[1]
Maximum Observed Concentration (Cmax)	6.95	ug/mL	Summary of pharmacokinetic parameters of AbGn-107 analytes following 0.4 mg/kg, Q4W.	[1]
Maximum Observed Concentration (Cmax)	17.9	ug/mL	Summary of pharmacokinetic parameters of AbGn-107 analytes following 0.8 mg/kg, Q4W.	[1]
Maximum Observed Concentration (Cmax)	18.2	ug/mL	Summary of pharmacokinetic parameters of AbGn-107 analytes following 1.2 mg/kg, Q4W.	[1]
Maximum Observed Concentration (Cmax)	13.8	ug/mL	Summary of pharmacokinetic parameters of AbGn-107 analytes following 0.8 mg/kg, Q2W.	[1]
Maximum Observed Concentration (Cmax)	20.2	ug/mL	Summary of pharmacokinetic parameters of AbGn-107 analytes following 1.2 mg/kg, Q2W.	[1]
Area Under the Concentration-Time Curve (AUC)	6.18	day·ug/mL	Summary of pharmacokinetic parameters of AbGn-107 analytes following 0.1mg/kg, Q4W, AUCd1-d29.	[1]
Area Under the Concentration-Time Curve (AUC)	6.82	day·ug/mL	Summary of pharmacokinetic parameters of AbGn-107 analytes following 0.2 mg/kg, Q4W, AUCd1-d29.	[1]
Area Under the Concentration-Time Curve (AUC)	19.8	day·ug/mL	Summary of pharmacokinetic parameters of AbGn-107 analytes following 0.4 mg/kg, Q4W, AUCd1-d29.	[1]
Area Under the Concentration-Time Curve (AUC)	39.2	day·ug/mL	Summary of pharmacokinetic parameters of AbGn-107 analytes following 0.8 mg/kg, Q4W, AUCd1-d29.	[1]
Area Under the Concentration-Time Curve (AUC)	75.9	day·ug/mL	Summary of pharmacokinetic parameters of AbGn-107 analytes following 1.2 mg/kg, Q4W, AUCd1-d29.	[1]
Area Under the Concentration-Time Curve (AUC)	67.7	day·ug/mL	Summary of pharmacokinetic parameters of AbGn-107 analytes following 0.8 mg/kg, Q2W, AUCd1-d29.	[1]
Area Under the Concentration-Time Curve (AUC)	112.9	day·ug/mL	Summary of pharmacokinetic parameters of AbGn-107 analytes following 1.2 mg/kg, Q2W, AUCd1-d29.	[1]

Standard Type	Value	Units	Description	Reference
Clearance (CL)	16.6	mL/day/kg	Summary of pharmacokinetic parameters of AbGn-107 analytes following 0.1mg/kg, Q4W.	[1]
Clearance (CL)	29.8	mL/day/kg	Summary of pharmacokinetic parameters of AbGn-107 analytes following 0.2 mg/kg, Q4W.	[1]
Clearance (CL)	21.7	mL/day/kg	Summary of pharmacokinetic parameters of AbGn-107 analytes following 0.4 mg/kg, Q4W.	[1]
Clearance (CL)	22.2	mL/day/kg	Summary of pharmacokinetic parameters of AbGn-107 analytes following 0.8 mg/kg, Q4W.	[1]
Clearance (CL)	19.9	mL/day/kg	Summary of pharmacokinetic parameters of AbGn-107 analytes following 1.2 mg/kg, Q4W.	[1]
Clearance (CL)	26.9	mL/day/kg	Summary of pharmacokinetic parameters of AbGn-107 analytes following 0.8 mg/kg, Q2W.	[1]
Clearance (CL)	22.5	mL/day/kg	Summary of pharmacokinetic parameters of AbGn-107 analytes following 1.2 mg/kg, Q2W.	[1]

Standard Type	NCT Number	Clinical Status	Clinical Trial Description
Undisclosed	NCT02908451	PHASE1	A Phase I Dose Escalation Study, With Cohort Expansion, to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of AbGn-107 Therapy in Patients With Chemo-refractory Locally Advanced, Recurrent, or Metastatic Gastric, Colorectal, Pancreatic or Biliary Cancer    Click to Show/Hide
Objective Response Rate (ORR)	NCT02908451	Phase 1	A phase 1 dose escalation study, with cohort expansion, to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ABGN-107 therapy in patients with chemo-refractory locally advanced, recurrent, or metastatic gastric, colorectal, pancreatic or biliary cancer.    Click to Show/Hide

Experiment 1 Reporting the Activity Date of This ADC					[2]
Patients Enrolled	Site-specific conjugation through the Sortase A.
Administration Dosage	AbGn-107 will be administered every 14-days or 28-days via intravenous infusion. Patients with a complete response (CR), partial response (PR), or stable disease (SD), or with evidence of clinical benefit may be treated every continuously every 14-days or 28-days.
Related Clinical Trial
NCT Number	NCT02908451	Clinical Status	PHASE1
Clinical Description	A Phase I Dose Escalation Study, With Cohort Expansion, to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of AbGn-107 Therapy in Patients With Chemo-refractory Locally Advanced, Recurrent, or Metastatic Gastric, Colorectal, Pancreatic or Biliary Cancer
Primary Endpoint	Safety will be assessed through the incidence and severity of adverse events (AEs) graded per CTCAE v4.03 standards during the initial 28-day treatment window.
Other Endpoint	Pharmacokinetic parameters (Cmax, Tmax, T1/2) and immunogenicity (anti-drug antibodies) will be evaluated over 70 days post-treatment, while tumor response will be measured by RECIST every 2-4 cycles per dosing regimen for up to 2 years.
Experiment 2 Reporting the Activity Date of This ADC					[3]
Efficacy Data	Objective Response Rate (ORR)	11.40%
Patients Enrolled	Patients with locally advanced or metastatic G, CRC, PDA, or BIL cancer, previously treated, ECOG PS 0-1, positive AG-7 expression was not required.
Administration Dosage	AbGn-107 administered iv Q4 weeks (from 0.10-1.20 mg/kg) and Q2 weeks (from 0.80-1.00 mg/kg).
Related Clinical Trial
NCT Number	NCT02908451	Clinical Status	Phase 1
Clinical Description	A phase 1 dose escalation study, with cohort expansion, to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ABGN-107 therapy in patients with chemo-refractory locally advanced, recurrent, or metastatic gastric, colorectal, pancreatic or biliary cancer.

Ref 1	A multicenter phase Ia study of AbGn-107, a novel antibody-drug conjugate, in patients with advanced gastrointestinal cancer
Ref 2	A Study of AbGn-107 in Patients With Gastric, Colorectal, Pancreatic or Biliary Cancer
Ref 3	A first-in-human, open label, multiple dose, dose escalation, and cohort expansion phase I study to investigate the safety, tolerability, pharmacokinetics and antitumor activity of BB-1701 in patients with locally advanced/metastatic HER2-expressing solid tumors. J Clin Oncol. 2023 41:16_suppl, 3029-3029.