. 2023 Oct 20;14(1):76–89. doi: 10.1158/2159-8290.CD-23-0964

Table 2.

Summary of cohorts for xaluritamig intravenous monotherapy dose exploration.

				C1 dosing, mg
Cohort	N	Step dosing	D1	D8	D15	D22	Target dose, mg	Frequency	DLTs	Tolerable	PSA50	PSA90	RECIST OR
Low dose	1	2	None	0.001				0.001	Weekly	0/1	Y	0/1	0/1	0/1
	2	4	None	0.003				0.003	Weekly	0/4	Y	0/4	0/4	0/4
	3	4	None	0.01				0.01	Weekly	0/4	Y	0/4	0/4	0/3
	4	4	None	0.03				0.03	Weekly	0/4	Y	1^a/4	1/4	0/2
	5	10	None	0.1				0.1	Weekly	2/9	Y	3/10	3/10	0/4
	6	6	None	0.3				0.3	Weekly	2/6	N	4/6	1/6	0/4
	7a	15	1 step	0.1		0.3		0.3	Weekly	2/12	Y	9/14	3/14	1/12
High dose	7b	12	2 step	0.1	0.3	1.0		1.0	Weekly	1/8	Y	6/10	3/10	4/10
	7c	7	2 step	0.1	0.3	1.0	N/A	1.0	Every 2 weeks^b	1/7	Y	3/7	2/7	2/6
	8	5	1 step	0.3		1.0		1.0	Weekly	2/4	N	2/5	2/5	1/5
	9	5	2 step	0.1	0.3	0.75		0.75	Weekly	2/5	Y	4/4	2/4	2/4
	10^c	5	1 step	0.1		1.0		1.0	Weekly	3/4	N	2/5	2/5	2/5
	11	6	3 step	0.1	0.3	1.0	1.5	1.5	Weekly	2/5	Y	5/5	3/5	4/4
	12	6	3 step	0.1	0.3	0.75	1.5	1.5	Weekly	0/5	Y	2/5	2/5	0/2
	13	7	3 step	0.1	0.3	1.0	2.0	2.0	Weekly	3/4	N	2/3	0/3	0/1

NOTE: Low dose, target dose <0.75 mg; high dose, target dose ≥0.75 mg. For DLTs, PSA50, PSA90, and RECIST OR, the denominator reflects number of patients evaluable for that endpoint.

Abbreviations: C, cycle; D, day; DLT, dose-limiting toxicity; N/A, not applicable; OR, objective response.

^aPatient responded following intra-patient dose escalation to the next higher dose level.

^bEvery 2 weeks administration after target dose was reached; step doses were weekly.

^cTwo patients in Cohort 10 did not receive the specified step dosing schedule as DLTs were seen in initial patients receiving 10-fold step dose. An additional 0.3-mg step dose was added to the schedule for these patients (0.1 mg D1, 0.3 mg D8, 1.0 mg D15+).