Anti-PD-1 monoclonal antibody MEDI0680 in a phase I study of patients with advanced solid malignancies

Naing, Aung; Infante, Jeffrey; Goel, Sanjay; Burris, Howard; Black, Chelsea; Marshall, Shannon; Achour, Ikbel; Barbee, Susannah; May, Rena; Morehouse, Chris; Pollizzi, Kristen; Song, Xuyang; Steele, Keith; Elgeioushi, Nairouz; Walcott, Farzana; Karakunnel, Joyson; LoRusso, Patricia; Weise, Amy; Eder, Joseph; Curti, Brendan; Oberst, Michael

doi:10.1186/s40425-019-0665-2

Table 3 Any-grade treatment-related AEs occurring in ≥10% of total population and all grade ≥ 3 treatment-related AEs

From: Anti-PD-1 monoclonal antibody MEDI0680 in a phase I study of patients with advanced solid malignancies

	Q3W (mg/kg)					Q2W (mg/kg)		QW × 2 (mg/kg)	QW × 4 (mg/kg)	Total
	Cohort 1 0.1 (n = 5)	Cohort 2 0.5 (n = 5)	Cohort 3 2.5 (n = 3)	Cohort 4 10 (n = 6)	Cohort 5 20 (n = 9)	Cohort 6 10 (n = 4)	Cohort 7 20 (n = 18)	Cohort 8 20 (n = 3)	Cohort 9 20 (n = 5)	N = 58
Any-grade treatment-related AE^a	5 (100)	4 (80)	3 (100)	5 (83)	5 (56)	4 (100)	15 (83)	3 (100)	4 (80)	48 (83)
Fatigue	0	1 (20)	0	1 (17)	1 (11)	1 (25)	7 (39)	1 (33)	0	12 (21)
Decreased appetite	2 (40)	1 (20)	2 (67)	1 (17)	0	0	3 (17)	0	0	9 (16)
Nausea	1 (20)	2 (40)	0	1 (17)	1 (11)	1 (25)	2 (11)	1 (33)	0	9 (16)
Vomiting	2 (40)	1 (20)	0	0	0	1 (25)	3 (17)	1 (33)	0	8 (14)
Anemia	0	1 (20)	0	0	1 (11)	0	3 (17)	0	2 (40)	7 (12)
Arthralgia	0	0	0	0	1 (11)	0	3 (17)	1 (33)	2 (40)	7 (12)
Pyrexia	1 (20)	1 (20)	0	1 (17)	0	1 (25)	2 (11)	0	1 (20)	7 (12)
Asthenia	0	1 (20)	0	0	1 (11)	0	4 (22)	0	0	6 (10)
Pruritus	1 (20)	0	1 (33)	0	1 (11)	0	3 (17)	0	0	6 (10)
Grade ≥ 3 treatment-related AEs^a	0	3 (60)	0	0	2 (22)	0	6 (33)	0	1 (20)	12 (20)
Anemia	0	1 (20)	0	0	1 (11)	0	1 (6)	0	1 (20)	4 (7)
Fatigue	0	1 (20)	0	0	1 (11)	0	0	0	0	2 (3)
Aspartate aminotransferase increased	0	1 (20)	0	0	0	0	1 (6)	0	0	2 (3)
Asthenia	0	0	0	0	1 (11)	0	0	0	0	1 (2)
Abdominal pain	0	0	0	0	0	0	1 (6)	0	0	1 (2)
Diarrhea	0	0	0	0	0	0	1 (6)	0	0	1 (2)
Autoimmune hepatitis	0	1 (20)	0	0	0	0	0	0	0	1 (2)
Urinary tract infection	0	0	0	0	0	0	1 (6)	0	0	1 (2)
Alanine aminotransferase increased	0	1 (20)	0	0	0	0	0	0	0	1 (2)
Blood alkaline phosphatase increased	0	1 (20)	0	0	0	0	0	0	0	1 (2)
Blood creatine phosphokinase increased	0	0	0	0	0	0	1 (6)	0	0	1 (2)
Lipase increased	0	0	0	0	1 (11)	0	0	0	0	1 (2)
Dehydration	0	0	0	0	1 (11)	0	0	0	0	1 (2)
Hypercalcemia	0	0	0	0	1 (11)	0	0	0	0	1 (2)
Hyperkalemia	0	0	0	0	0	0	1 (6)	0	0	1 (2)
Arthralgia	0	0	0	0	0	0	1 (6)	0	0	1 (2)
Myositis	0	0	0	0	0	0	1 (6)	0	0	1 (2)
Myasthenia gravis	0	0	0	0	0	0	1 (6)	0	0	1 (2)
Hypertension	0	0	0	0	0	0	1 (6)	0	0	1 (2)

All grade ≥ 3 events were grade 3, with the exception of two grade 4 events (one event of increased blood creatine phosphokinase and one event of myositis)
Abbreviation: AE adverse event
^aPatients were counted once for each category regardless of the number of events

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