Table 1.

Patient demographics, clinical characteristics, and disposition

Characteristic	Monotherapy				Combination
	1.25 mg/kg (n = 1)	3.75 mg/kg (n = 1)	7.5 mg/kg (n = 2)	Total (N = 4)	3.75 mg/kg (n = 10)	7.5 mg/kg (n = 13)	Total (N = 23)
Age, years, median (range)	82 (82-82)	71 (71-71)	75 (71-78)	75 (71-78)	72 (60-79)	71 (35-82)	71 (35-82)
Sex, n (%)
Female	1 (100)	1 (100)	1 (50)	3 (75)	2 (20)	7 (54)	9 (39)
Male	0	0	1 (50)	1 (25)	8 (80)	6 (46)	14 (61)
Time from diagnosis, years, median (range)	1.4 (1.4-1.4)	0.3 (0.3-0.3)	1.1 (0.8-1.3)	1.1 (0.3-1.4)	1.1 (0.2-2.7)	0.8 (0.1-4.6)	1 (0.1-4.6)
Previous therapies, n (%)
0	0	0	0	0	1 (10)	1 (8)	2 (9)
1	0	0	1 (50)	1 (25)	4 (40)	6 (46)	10 (43)
2	0	1 (100)	0	1 (25)	5 (50)	2 (15)	7 (30)
3	0	0	1 (50)	1 (25)	0	0	0
4	1 (100)	0	0	1 (25)	0	0	0
≥5	0	0	0	0	0	4 (31)	4 (17)
Study drug discontinuation, n	1	1	2	4	9	12	21
Primary reason, n (%)
Adverse event	0	0	0	0	2 (22)	2 (17)	4 (19)
Withdrawal of consent	0	0	0	0	1 (11)	1 (8)	2 (9)
Progressive disease	1 (100)	0	0	1 (25)	5 (56)	6 (50)	11 (52)
Physician decision	0	1 (100)	1 (50)	2 (50)	0	1 (8)	1 (5)
Other	0	0	1 (50)	1 (25)	1 (11)	2 (17)	3 (14)