Site-specific conjugation through the Sortase A.

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.

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

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.

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.

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.

AbGn-107 administered iv Q4 weeks (from 0.10-1.20 mg/kg) and Q2 weeks (from 0.80-1.00 mg/kg).

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.