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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).