Comparative clinical pharmacokinetics of antibody-drug conjugates in first-in-human Phase 1 studies

Gemtuzumab ozogamicin in acute myeloid leukemia: a remarkable saga about an active drug

(2013) J. M. Rowe et al.   BLOOD

An Integrated Multiple-Analyte Pharmacokinetic Model to Characterize Trastuzumab Emtansine (T-DM1) Clearance Pathways and to Evaluate Reduced Pharmacokinetic Sampling in Patients with HER2-Positive Metastatic Breast Cancer

(2013) Dan Lu et al.   CLINICAL PHARMACOKINETICS

Validation of an immunoassay to selectively quantify the naked antibody of a new Antibody Drug Conjugate – SAR566658 – for pharmacokinetic interpretation improvement

(2013) Marie-Helene Pascual et al.   JOURNAL OF IMMUNOLOGICAL METHODS

On translation of antibody drug conjugates efficacy from mouse experimental tumors to the clinic: a PK/PD approach

(2013) Nahor Haddish-Berhane et al.   JOURNAL OF PHARMACOKINETICS AND PHARMACODYNAMICS

Maturing antibody–drug conjugate pipeline hits 30

(2013) Asher Mullard   NATURE REVIEWS DRUG DISCOVERY

Considerations for the nonclinical safety evaluation of antibody drug conjugates for oncology

(2013) Stanley A. Roberts et al.   REGULATORY TOXICOLOGY AND PHARMACOLOGY

Bioanalysis of antibody–drug conjugates: American Association of Pharmaceutical Scientists Antibody–Drug Conjugate Working Group position paper

(2013) Boris Gorovits et al.   Bioanalysis

Preclinical and clinical pharmacokinetic/pharmacodynamic considerations for antibody–drug conjugates

(2013) Puja Sapra et al.   Expert Review of Clinical Pharmacology

Clinical pharmacology of trastuzumab emtansine (T-DM1): an antibody–drug conjugate in development for the treatment of HER2-positive cancer

(2012) Sandhya Girish et al.   CANCER CHEMOTHERAPY AND PHARMACOLOGY

Phase 1, open-label study of MEDI-547 in patients with relapsed or refractory solid tumors

(2012) Christina M. Annunziata et al.   INVESTIGATIONAL NEW DRUGS

Phase I Multidose-Escalation Study of the Anti-CD19 Maytansinoid Immunoconjugate SAR3419 Administered by Intravenous Infusion Every 3 Weeks to Patients With Relapsed/Refractory B-Cell Lymphoma

(2012) Anas Younes et al.   JOURNAL OF CLINICAL ONCOLOGY

Results From a Pivotal, Open-Label, Phase II Study of Romidepsin in Relapsed or Refractory Peripheral T-Cell Lymphoma After Prior Systemic Therapy

(2012) Bertrand Coiffier et al.   JOURNAL OF CLINICAL ONCOLOGY

Effect of gemtuzumab ozogamicin on survival of adult patients with de-novo acute myeloid leukaemia (ALFA-0701): a randomised, open-label, phase 3 study

(2012) Sylvie Castaigne et al.   LANCET

Phase I studies of AVE9633, an anti-CD33 antibody-maytansinoid conjugate, in adult patients with relapsed/refractory acute myeloid leukemia

(2011) Simona Lapusan et al.   INVESTIGATIONAL NEW DRUGS

Dose-Levels and First Signs of Efficacy in Contemporary Oncology Phase 1 Clinical Trials

(2011) Charles Ferte et al.   PLoS One

Population Pharmacokinetics of Therapeutic Monoclonal Antibodies

(2010) Nathanael L. Dirks et al.   CLINICAL PHARMACOKINETICS

Clinical Pharmacokinetics of Therapeutic Monoclonal Antibodies

(2010) Ron J. Keizer et al.   CLINICAL PHARMACOKINETICS

Safety, Pharmacokinetics, and Preliminary Clinical Activity of Inotuzumab Ozogamicin, a Novel Immunoconjugate for the Treatment of B-Cell Non-Hodgkin's Lymphoma: Results of a Phase I Study

(2010) Anjali Advani et al.   JOURNAL OF CLINICAL ONCOLOGY

Phase I Study of Trastuzumab-DM1, an HER2 Antibody-Drug Conjugate, Given Every 3 Weeks to Patients With HER2-Positive Metastatic Breast Cancer

(2010) Ian E. Krop et al.   JOURNAL OF CLINICAL ONCOLOGY

Phase I Trial of the Prostate-Specific Membrane Antigen–Directed Immunoconjugate MLN2704 in Patients With Progressive Metastatic Castration-Resistant Prostate Cancer

(2008) Matthew D. Galsky et al.   JOURNAL OF CLINICAL ONCOLOGY