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

Table 2 Study summary

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 metastasis^a	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 3^a	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 dyspnoe^b	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

ALT, alanine aminotransferase; AST, aspartate aminotransferase; GGT, gamma-glutamyl transferase; n.d., not determined.
^aCausal relationship with study drug unlikely.
^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.
^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).

ISSN: 1465-542X