Clinical trialPhase 1Terminated
A Study of AbGn-107 in Patients With Gastric, Colorectal, Pancreatic or Biliary Cancer
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
- Outcome
- Stopped earlyCOVID-19 pandemic has caused a huge operational difficulty for this ongoing clinical trial, as many hospitals have set limitations on onsite staff, patient visits, study related procedures and onsite monitoring visits. (Other)
- Phase
- Phase 1
- Status
- Terminated
- Study type
- Interventional
- Start
- 24 April 2017
- Expected end
- 28 February 2021
- Enrollment
- 39 participants
- Sites
- 9
- Primary outcomes
- Adverse events (AEs) graded according to CTCAE v4.03.
- Sponsor
- Industry
- Results posted
- No
- Last update
- 13 July 2021
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Brief summary public domain (ClinicalTrials.gov)
This study is to define the safety profile and to determine the Maximal tolerated dose regimen and preliminary efficacy of AbGn-107 administered every 14 days (Q2W regimen) or 28 days (Q4W regimen) in patients with chemo-refractory locally advanced, recurrent or metastatic gastric, colorectal, pancreatic or biliary cancer.
Detailed description public domain (ClinicalTrials.gov)
AbGn-107 is an antibody drug conjugate (ADC) which targets an antigen (AG7 antigen) present in gastric, colorectal, pancreatic cancer or biliary cancer. This study is a standard 3 + 3 dose escalation design with cohort expansion. AbGn-107 will be administered every 14 days (Q2W regimen) or 28 days (Q4W regimen) in patients with chemo-refractory locally advanced, recurrent or metastatic gastric, colorectal, pancreatic adenocarcinoma or biliary cancer. The primary objectives of this study are to define the safety profile and to determine the maximum tolerated dose regimen of AbGn-107, and the secondary objectives are to evaluate the pharmacokinetic (PK) parameters, the immunogenicity, and preliminary efficacy of AbGn-107.