Table 1.

Baseline Characteristics and Demographics

	Dose Escalation				Dose Expansion	All Patients
	80 mg ORIC-101 + 160 mg enzalutamide (N=4)	160 mg ORIC-101 + 160 mg enzalutamide (N=3)	240 mg ORIC-101 + 160 mg enzalutamide (N=3)	Total (N=10)	240 mg ORIC-101 + 160 mg enzalutamide (N=31)	Total (N=41)
Age, years
Median (range)	71 (70, 83)	68 (60, 68)	72 (70, 79)	70 (60, 83)	70 (53, 82)	70 (53, 83)
Race, n (%)
White	4 (100)	3 (100)	3 (100)	10 (100)	24 (77.4)	34 (82.9)
African American	0	0	0	0	5 (16.1)	5 (12.2)
Asian	0	0	0	0	1 (3.2)	1 (2.4)
Other	0	0	0	0	1 (3.2)	1 (2.4)
ECOG, n (%)
0	4 (100)	3 (100)	3 (100)	10 (100)	17 (54.8)	27 (65.9)
1	0	0	0	0	14 (45.2)	14 (34.1)
Total Gleason Score, n (%)
<7	2 (50)	0	2 (66.7)	4 (40)	6 (19.4)	10 (24.4)
8–10	1 (25)	2 (66.7)	1 (33.3)	4 (40)	18 (58.0)	22 (53.6)
Unknown	1 (25)	1 (33.3)	0	2 (20)	7 (22.6)	9 (22.0)
Site of Metastasis, n (%)
Bone	4 (100)	3 (100)	3 (100)	10 (100)	23 (74.2)	33 (80.5)
Lung	0	0	0	0	2 (6.5)	2 (4.9)
Lymph	0	0	0	0	3 (9.7)	3 (7.3)
Other	0	0	0	0	2 (6.5)	2 (4.9)
PSA (ng/mL)
Median (range)	20.5 (1.4, 69.7)	13.1 (2.6, 24.9)	7.4 (2.4, 16.1)	10.3 (1.4, 69.7)	13.2 (0.8, 583.5)	13.1 (0.8, 583.5)
Prior therapies in mCRPC, n (%)
Hormonal	4 (100)	3 (100)	3 (100)	9 (90)	31 (100)	41 (100)
Chemotherapy	0	0	0	0	7 (22.6)	7 (17.1)
Other	1 (25)	0	1 (33.3)	2 (20)	8 (25.8)	10 (24.4)
Prior Anticancer Surgery, n (%)	0	0	0	0	0	0
Prior Radiation Therapy, n (%)	2 (50)	0	0	2 (20)	4 (12.9)	6 (14.6)

ECOG: Eastern Oncology Cooperative Group; PSA: prostate-specific antigen; ADT: androgen-deprivation therapy (pharmacological)