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- sefaldin (ABD-3001) / Advanced BioDesign
Phase classification, Monotherapy: ODYSSEY: First-in-human Study Aiming to Characterize the Safety, Tolerability, Pharmacokinetic and Preliminary Signs of Activity of ABD-3001 in Refractory or Relapsed AML and High Risk MDS Adult Patients (clinicaltrials.gov) - Nov 11, 2024
P1/2, N=36, Recruiting, Sponsor: Advanced BioDesign
Phase classification: P1 --> P1/2
- || sefaldin (ABD-3001) / Advanced BioDesign
Enrollment open, Monotherapy: ODYSSEY: First-in-human Study Aiming to Characterize the Safety, Tolerability, Pharmacokinetic and Preliminary Signs of Activity of ABD-3001 in Refractory or Relapsed AML and High Risk MDS Adult Patients (clinicaltrials.gov) - Oct 28, 2024
P1, N=7, Recruiting, Sponsor: Advanced BioDesign
Phase classification: P1 --> P1/2 Active, not recruiting --> Recruiting
- | sefaldin (ABD-3001) / Advanced BioDesign
Biomarker, Journal: Reactive oxygen species and aldehyde dehydrogenase 1A as prognosis and theragnostic biomarker in acute myeloid leukaemia patients. (Pubmed Central) - Oct 11, 2024
P1
In multivariate analysis, ROS level was the most significant (p?<?0.05) and the strongest predictive factor for the sensitivity of cells to ABD-3001. The safety profile of ABD-3001 is currently being assessed through the first inhuman multicenter phase 1 clinical trial "ODYSSEY" (NCT05601726) for patients with relapsed AML.
- | sefaldin (ABD-3001) / Advanced BioDesign
Trial completion date, Trial primary completion date, Monotherapy: ODYSSEY: First-in-human Study Aiming to Characterize the Safety, Tolerability, Pharmacokinetic and Preliminary Signs of Activity of ABD-3001 in Refractory or Relapsed AML and High Risk MDS Adult Patients (clinicaltrials.gov) - Jul 22, 2024
P1, N=7, Active, not recruiting, Sponsor: Advanced BioDesign
The safety profile of ABD-3001 is currently being assessed through the first inhuman multicenter phase 1 clinical trial "ODYSSEY" (NCT05601726) for patients with relapsed AML. Trial completion date: Dec 2024 --> Dec 2026 | Trial primary completion date: Oct 2024 --> Jun 2026
- | sefaldin (ABD-3001) / Advanced BioDesign
Trial completion date, Trial primary completion date, Monotherapy: ODYSSEY: First-in-human Study Aiming to Characterize the Safety, Tolerability, Pharmacokinetic and Preliminary Signs of Activity of ABD-3001 in Refractory or Relapsed AML and High Risk MDS Adult Patients (clinicaltrials.gov) - Dec 18, 2023
P1, N=7, Active, not recruiting, Sponsor: Advanced BioDesign
- || sefaldin (ABD-3001) / Advanced BioDesign
Enrollment closed, Enrollment change, Monotherapy: ODYSSEY: First-in-human Study Aiming to Characterize the Safety, Tolerability, Pharmacokinetic and Preliminary Signs of Activity of ABD-3001 in Refractory or Relapsed AML and High Risk MDS Adult Patients (clinicaltrials.gov) - Jan 20, 2023
P1, N=3, Active, not recruiting, Sponsor: Advanced BioDesign
Trial completion date: Dec 2024 --> Dec 2026 | Trial primary completion date: Oct 2024 --> Jun 2026 Recruiting --> Active, not recruiting | N=50 --> 3
- | sefaldin (ABD-3001) / Advanced BioDesign
New P1 trial, Monotherapy: ODYSSEY: First-in-human Study Aiming to Characterize the Safety, Tolerability, Pharmacokinetic and Preliminary Signs of Activity of ABD-3001 in Refractory or Relapsed AML and High Risk MDS Adult Patients (clinicaltrials.gov) - Nov 1, 2022
P1, N=50, Recruiting, Sponsor: Advanced BioDesign