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Table 2 Study summary

From: Phase I clinical study of the recombinant antibody toxin scFv(FRP5)-ETA specific for the ErbB2/HER2 receptor in patients with advanced solid malignomas

Patient Dose level (μg/kg) Course of therapy Toxicities ≥ grade 1 Dose-limiting toxicity Neutralizing antibodies Clinical response
N01 2 According to plan GGT grade 2 No No Progression
U01 2 According to plan None No n.d. Progression
U02 2 Stopped on day 10 Cholestasis due to liver metastasisa No n.d. Progression
N03 4 According to plan GGT grade 2 No No Progression
N04 4 According to plan ALT grade 1 No No Progression
N05 4 According to plan Hemoglobin grade 3a No No Progression
N06 10 According to plan ALT grade 2, AST grade 1 No + Stable disease
N07 10 According to plan ALT/AST grade 1, GGT grade 2 No No Progression
U03 10 According to plan Fever and dyspnoeb No ++ n.d.c
N13 12.5 According to plan ALT grade 1, GGT grade 2, AP grade 1 No No Progression
N14 12.5 Stopped on day 8 ALT/AST grade 3, GGT grade 2, LDH grade 1 Yes n.d. n.d.
N15 12.5 According to plan ALT grade 2, AST grade 1, AP grade 2 No + Stable disease
N17 12.5 According to plan ALT/AST grade 2 No No Progression
U04 12.5 According to plan Dyspnoe No No n.d.c
U05 12.5 According to plan None No ++ Progression
N09 20 According to plan ALT/AST grade 2 No +++ Progression
N10 20 Stopped on day 8 ALT grade 4, AST grade 3, GGT grade 2 Yes n.d. n.d.
N12 20 Stopped on day 8 ALT grade 3, AST grade 2 Yes n.d. n.d.c
  1. ALT, alanine aminotransferase; AST, aspartate aminotransferase; GGT, gamma-glutamyl transferase; n.d., not determined.
  2. aCausal relationship with study drug unlikely.
  3. bPatient U03 developed fever and dyspnoe after therapy on day 23, which was resolved with antibiotics; the patient died on day 40, causal relationship with study drug unlikely.
  4. cClinical signs of activity while on therapy including healing of cutaneous lesion (U03, U04), size reduction of lymph node metastasis (U03), and inflammatory response and softening of large tumor mass (N12).