Table 3.
The most common (≥3 % of patients overall) drug-related grade ≥3 AEs, overall and within the dose-escalation and expansion cohorts
| AE, n (%) | Dose-escalation cohort (n = 23) | MTD expansion cohorts (n = 93) | Total (N = 116) | ||||
|---|---|---|---|---|---|---|---|
| NSCLC (n = 20) | H&N (n = 22) | STS (n = 20) | PC (n = 11) | TPEC (n = 20) | |||
| Thrombocytopenia | 5 (22) | 2 (10) | 7 (32) | 3 (15) | 3 (27) | 7 (35) | 27 (23) |
| Skin and SC tissue disordersa | 2 (9) | 4 (20) | 4 (18) | 5 (25) | 2 (18) | 1 (5) | 18 (16) |
| Fatigue | 1 (4) | 1 (5) | 2 (9) | 2 (10) | 2 (18) | 3 (15) | 11 (9) |
| Dehydration | 1 (4) | 1 (5) | 3 (14) | 0 | 0 | 2 (10) | 7 (6) |
| Lymphopenia | 0 | 1 (5) | 1 (5) | 1 (5) | 0 | 3 (15) | 6 (5) |
| Anemia | 0 | 2 (10) | 0 | 0 | 0 | 1 (5) | 3 (3) |
| Decreased platelet count | 0 | 2 (10) | 0 | 1 (5) | 0 | 0 | 3 (3) |
| Dyspnea | 0 | 1 (5) | 1 (5) | 0 | 1 (9) | 0 | 3 (3) |
| Nausea | 1 (4) | 0 | 1 (5) | 0 | 0 | 1 (5) | 3 (3) |
| Peripheral neuropathies NECb | 1 (4) | 0 | 0 | 0 | 1 (9) | 1 (5) | 3 (3) |
| Vomiting | 1 (4) | 0 | 0 | 1 (5) | 0 | 1 (5) | 3 (3) |
aMedDRA System Organ Class – includes rash maculo-papular (n = 8, 7 %), rash macular (n = 3, 3 %), rash (n = 1, <1 %), rash pruritic (n = 4, 3 %), rash erythematous (n = 2, 2 %), erythema nodosum, and rash papular (each n = 1, <1 %). Patients could have reported >1 AE
bHigh-level term, Peripheral neuropathies NEC – includes neuropathy peripheral and peripheral sensory neuropathy
AE adverse event, H&N head and neck cancer, MTD maximum tolerated dose, NEC not elsewhere classified, NSCLC non-small cell lung cancer, PC prostate cancer, SC subcutaneous, STS soft tissue sarcoma, TPEC tumor pharmacodynamic expansion cohort