Table 3.

Treatment Efficacy by Dose Level

Patient	Dose Level	Best RECIST Response on study	Baseline primary tumor diameter (cm) *	Max % change in primary tumor	Best CA19-9 response on study	hRRM1 Max Change	hRRM2 Max Change	Time to 1st progression (months)a	OS (months)	Post-study therapy (Yes/No)
1	1	PR	2.8	46% ↓	NEb	NAc	NAc	4.9	18.6	Yes
2	1	PD	4.5	No change	NE	NAc	12% ↓e	2	6.1	Yes
3	1	PD	5.6	16% ↑	NE	No change	6% ↓	0.8	2.8	Yes
4	1	SDd	2.2	25% ↓	56% ↓	12% ↑e	8% ↑e	8.4	14.6	Yesf
5	2	SD	2.1	No change	21% ↓	13% ↑e	7% ↑e	7.5	9.1	Yes
6	2	PD	5.1	18% ↓	NE	13% ↑	No change	2.1	6.7	Yes
7	2	SD	3.4	12% ↓	68% ↓	3% ↓e	14% ↓e	10.2	11.6	Yes
8	3	PR	6.1	38% ↓	62% ↓	9% ↓e	4% ↓e	6.8	6.8	Yes
9	3	PD	4.3	13% ↓	NE	3% ↓	3% ↓	0.8	1	No
10	3	SD	3.8	5% ↓	147% ↑	4% ↓	15% ↑	6.3	6.3	No
11	3	SD	3.8	12% ↓	47% ↓	7% ↓e	9% ↓e	6.1	6.1	Yes
12	3	SD	4.6	22% ↓	360% ↑	16% ↓e	15% ↓e	4.4	9.4	Yes

^*Denotes longest cross-sectional diameter

^aIncludes post-study therapy

^bNE: not evaluable- data not available (N=3) or CA 19-9 not elevated (N=1)

^cData not available

^dPatient underwent pancreaticoduodenectomy post-study

^eIndicates complete (Day 1 and Day 33) data available

^fPatient received adjuvant therapy and subsequent treatment for metastatic disease