Fig 1.
Flow diagram of participants through each stage of the study.
Table 1.
Baseline Patient Demographic and Clinical Characteristics.
Abbreviations: ECOG, Eastern Cooperative Oncology Group.
Table 2.
EGFRminicellsPac first-time-in-human, phase I trial: dosing and response summary (safety population; N = 28).
Abbreviations: ALT, alanine transaminase; AST, aspartate aminotransferase; NA, patient did not complete Cycle 1 of treatment, therefore disease response at the completion of Cycle 1 (5 doses) is not available; SD, stable disease; PD, progressive disease.
Table 3.
Adverse events by Grade, with a possible, probable or definite relationship to EGFRminicellsPac (N = 28).
Abbreviation: AE, Adverse Event.
Fig 2.
Mild elevations in white blood cells and neutrophils, and drops in lymphocytes and monocytes were observed post dose. (A) The mean values (1x108, n = 5; 1x109, n = 5; 3x109, n = 4; 1x1010, n = 5) are shown for each dose level up to and including the MTD for Cycle 1 of treatment at pre-dose, 4h and 24h post-dose. Dotted lines indicate normal ranges, error bars indicate the standard error of the mean. (B) Values for Cycle 1 of treatment at pre-dose, 4h and 24h post-dose for 5 individuals who received a treatment dose above the MTD. Grey box indicates samples collected from dose levels above the MTD. Dotted lines indicate normal ranges.
Fig 3.
At 4h post-dose, IL-6, IL-8, and IL-10 spiked and returned to normal by 24h post-dose. IFNα was elevated in certain patients for the duration of the study. The mean values (1x108, n = 5; 1x109, n = 5; 3x109, n = 4; 1x1010, n = 5) are shown for each dose level up to and including the MTD for Cycle 1 of treatment at pre-dose, 4h and 24h post-dose.
Fig 4.
Anti-LPS antibody titers following administration of EGFRminicellsPac.
Blood samples were collected at dosing and serum was analyzed for anti-LPS IgG. Results are expressed as the reciprocal antibody titer, expressed as Log10. The x-axis shows days of treatment and error bars indicate the standard error of the mean. (A) The mean anti-LPS antibody titer for each dose level (1x108, n = 5; 1x109, n = 5; 3x109, n = 4; 1x1010, n = 5) up to and including the MTD for Cycle 1 of treatment (5 doses). (B) Anti-LPS antibody responses in 5 individuals treated with EGFRminicellsPac at dose levels above the MTD. (C) Anti-LPS antibody responses in 5 individuals that received at least 15 doses of EGFRminicellsPac.