Evidence Level:Sensitive: C2 – Inclusion Criteria
Title:
PF-06804103 Dose Escalation in HER2 Positive and Negative (Negative Only in Part 2) Solid Tumors
Excerpt:...Maximum Observed Concentration (Cmax) - Part 1A`Maximum Observed Concentration (Cmax) - Part 2A`Maximum Observed Concentration (Cmax) Part B`Time to reach maximum observed concentration (Tmax) - Part 1A`Time to reach maximum observed concentration (Tmax) - Part 2A`Time to reach maximum observed concentration (Tmax) - Part B`Area under the curve from time zero to end of dosing interval (AUCtau) Part 1A`Area under the curve from time zero to end of dosing interval (AUCtau) Part 2A`Area under the curve from time zero to end of dosing interval (AUCtau) Part B`Area under the concentration-time curve from time 0 to the last measurable concentration (AUClast) Part 1A`Area under the concentration-time curve from time 0 to the last measurable concentration (AUClast) Part 2A`Area under the concentration-time curve from time 0 to the last measurable concentration (AUClast) Part B`Incidence and titers of anti-drug antibodies Part A`Incidence and titers of anti-drug antibodies Part B`Incidence and titers of neutralizing antibodies Part A`Incidence and titers of neutralizing antibodies Part B`Number of participant with objective response`Progression-Free Survival (PFS)`HER2 expression level in patients with documented anti-tumor activity`Duration of Response (DR)`Time to Tumor Progression (TTP)...
Evidence Level:Sensitive: D – Preclinical
Title:
PF-06804103, A Site-specific Anti-HER2 Antibody–Drug Conjugate for the Treatment of HER2-expressing Breast, Gastric, and Lung Cancers
Excerpt:...we evaluated the in vivo activity of PF-06804103 in a panel of HER2-expressing gastric...and non–small cell lung...cancer PDX models. In the PDX-GAX-0044 (Fig. 3G) and PDX-NSX-26110 (Fig. 3I) models, PF-06804103 resulted in sustained tumor regressions as compared with PT-DM1.
DOI:https://doi.org/10.1158/1535-7163.MCT-20-0237