Table 3.

Response rate per RECIST v1.1 (full analysis set)

	Total (n=47)	Tumor type
		CRC (n=41)	SCCHN (n=6)
Best overall response
CR	0	0	0
PR	1 (2.1)	1 (2.4)	0
SD	21 (44.7)	18 (43.9)	3 (50.0)
PD	23 (48.9)	21 (51.2)	2 (33.3)
No data	2 (4.3)	1 (2.4)	1 (16.7)
Objective response rate	1 (2.1)	1 (2.4)	0
95% CI	0.05, 11.29	0.06, 12.86	NE, NE
Clinical benefit rate	3 (6.4)	3 (7.3)	0
95% CI	1.34, 17.54	1.54, 19.92	NE, NE

Data are n (%) unless specified otherwise.

The BoR on-study was defined as the best response designation recorded between the date of first dose and the date of first objectively documented progression based on RECIST v1.1 criteria, or the date of subsequent therapy, whichever occurred first. CR or PR determinations must have been confirmed by a second scan no less than 4 weeks after the criteria for response are first met.

CBR was calculated as the proportion of patients who achieved a BoR of CR or PR at any time, or SD lasting ≥12 weeks.

BoR, best overall response; CBR, clinical benefit rate; CR, complete response; CRC, colorectal cancer; NE, Not evaluable; PD, progressive disease; PR, partial response; SCCHN, squamous cell cancer of the head and neck; SD, stable disease.