A phase I study of the safety and activity of K-001 in patients with advanced pancreatic ductal adenocarcinoma

BMC Cancer

Table 5 Antitumor activity of K-001 in PDAC patients

Patient ID	Dose cohort (mg, BID)	Best overall response	Change in tumor size from baseline (%)	NRS			QoL			CRP (mg/L)			OS (days)
Patient ID	Dose cohort (mg, BID)	Best overall response	Change in tumor size from baseline (%)	Baseline	Day 29	Day 56	Baseline	Day 29	Day 56	Baseline	Day 29	Day 56	OS (days)
1	1350	SD	0^b	4	3	3	50	50	50	0.5	1.4	0.8	457
2	1350	SD	4.4^b	5	8	8	47	54	54	5.4	49.4	62.7	167
3	1350	SD	4.3	8	8	4	74	68	85	33.6	8.0	67.2	114
4	1620	SD	9.4	0	3	NE	34	53	NE	64.2	88.5	NE	101
6	1620	SD	−2.9	5	8	7	56	67	73	3.4	13.5	3.6	378
7	1620	SD	0^b	2	2	2	51	48	86	0.3	0.4	3.3	171
9	1890	SD	0^b	2	4	3	31	28	30	3.7	1.2	7.9	759
10	1890	PD	−28.6^a	4	4	NE	52	47	NE	5.0	21.8	NE	79
11	1890	PD	0^ab	1	1	1	31	31	40	2.1	35.0	5.9	294
13	2160	SD	0^b	5	5	5	57	58	59	0.1	2.8	0.3	441
16	2160	SD	2.2^b	1	1	3	35	32	32	1.4	0.5	1.0	396
18	2160	SD	2.1^b	4	3	4	54	51	50	0.8	0.9	6.6	166

Abbreviations: SD stable disease, PD progressive disease, NE not evaluable
^a Disease progression due to the appearance of new lesions
^b Showed the percent change of the of target lesion (PDAC) as compared with baseline

ISSN: 1471-2407