Table 3:
Adverse Events Related to Treatment in ≥ 4 patients
| Dose Level 1 (n=3) | Dose Level 2 (n=14) | Dose Level 3 (n=7) | Dose Level 4 (n=9) | (n=33) | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event (n, %) | ≤G2 | G3 | G4 | Total | ≤G2 | G3 | G4 | Total | ≤G2 | G3 | G4 | Total | ≤G2 | G3 | G4 | Total | Total |
| Fatigue | 1(33) | 0 | 1(33) | 4(29) | 4(29) | 0 | 8(57) | 4(57) | 1(14) | 5(71) | 6(67) | 2(22) | 8(89) | 22(65) | |||
| Nausea | 2(67) | 2(67) | 6(43) | 6(43) | 2(29) | 2(29) | 4(44) | 4(44) | 14(41) | ||||||||
| Anemia | 1(33) | 1(33) | 1(7) | 6(43) | 7(50) | 2(29) | 2(29) | 1(11) | 2(22) | 3(33) | 13(38) | ||||||
| Diarrhea | 1(33) | 1(33) | 1(7) | 1(7) | 2(29) | 1(14) | 3(43) | 4(44) | 4(44) | 9(26) | |||||||
| Pain | 3(21) | 3(21) | 3(43) | 1(14) | 4(57) | 2(22) | 2(22) | 9(26) | |||||||||
| Anorexia | 3(21) | 3(21) | 4(57) | 4(57) | 2(22) | 2(22) | 9(26) | ||||||||||
| AST/ALT increased | 2(14) | 2(14) | 4(29) | 1(14) | 1(14) | 2(29) | 1(11) | 1(11) | 2(22) | 8(24) | |||||||
| Rash | 1(7) | 1(7) | 4(57) | 4(57) | 2(22) | 2(22) | 4(44) | 8(24) | |||||||||
| ALP increased | 4(29) | 1 (7) | 5(36) | 1(14) | 1(14) | 2(22) | 2(22) | 8(24) | |||||||||
| Thrombocytopenia | 4(29) | 4(29) | 2(29) | 2(29) | 2(22) | 2(22) | 8(24) | ||||||||||
| Vomiting | 5(36) | 5(36) | 1(14) | 1(14) | 1(11) | 1(11) | 7(21) | ||||||||||
| Neutropenia | 1(7) | 4(29) | 5(36) | 2(29) | 2(29) | 7(21) | |||||||||||
| Weight loss | 2(67) | 2(67) | 3(21) | 3(21) | 2(29) | 2(29) | 7(21) | ||||||||||
| Hypokalemia | 1(33) | 1(33) | 2(14) | 2(14) | 1(14) | 1(14) | 2(22) | 2(22) | 6(18) | ||||||||
| Dry mouth | 4(29) | 4(29) | 1(14) | 1(14) | 1(11) | 1(11) | 6(18) | ||||||||||
| Hypoalbuminemia | 2(14) | 1(7) | 3(21) | 1(14) | 1(14) | 2(22) | 2(22) | 6(18) | |||||||||
| Hyponatremia | 2(14) | 2(14) | 1(7) | 5(36) | 1(14) | 1(14) | 6(18) | ||||||||||
| Lipase increased | 1(7) | 1(7) | 2(14) | 1(14) | 1(14) | 2(29) | 1(11) | 1(11) | 2(22) | 6(18) | |||||||
| Leukopenia | 3(21) | 3(21) | 2(29) | 2(29) | 1(11) | 1(11) | 6(18) | ||||||||||
| Lymphopenia | 1(33) | 1(33) | 2(14) | 1(7) | 3(21) | 2(29) | 2(29) | 6(18) | |||||||||
| Pruritus | 2(14) | 2(14) | 2(29) | 2(29) | 2(22) | 2(22) | 6(18) | ||||||||||
| Dysgeusia | 1(33) | 1(33) | 3(21) | 3(21) | 2(22) | 2(22) | 6(18) | ||||||||||
| Hypophosphatemia | 3(21) | 1(7) | 4(29) | 1(14) | 1(14) | 5(15) | |||||||||||
| Hypothyroidism | 3(21) | 3(21) | 1(14) | 1(14) | 1(11) | 1(11) | 5(15) | ||||||||||
| Constipation | 1(33) | 1(33) | 1(7) | 1(7) | 1(14) | 1(14) | 1(11) | 1(11) | 4(12) | ||||||||
| Dizziness | 1(7) | 1(7) | 2(29) | 2(29) | 1 (11) | 1(11) | 4(12) | ||||||||||
| Dyspnea | 1(33) | 1(33) | 2(14) | 2(14) | 1(14) | 1(14) | 4(12) | ||||||||||
| Hypocalcemia | 3(21) | 3(21) | 1(14) | 1(14) | 4(12) | ||||||||||||
| Peripheral neuropathy | 1(7) | 1(7) | 2(29) | 2(29) | 1(11) | 1(11) | 4(12) | ||||||||||
| Amylase increased | 3(21) | 3(21) | 1(14) | 1(14) | 4(12) | ||||||||||||
Adverse events (AEs) related to treatment in ≥ 4 patients. Note: Number of worst grade adverse events (AEs) possibly, probably, or definitely attributed to study drug administration. Toxicities graded per the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5 criteria. Note: Possible immune-related AEs not included in Table 3 due to frequency < 4 include hyperthyroidism, colitis, pneumonitis, meningoencephalitis and myasthenia gravis. Abbreviations: ≤G2=Grade 1 and 2, G3=Grade 3, G4=Grade 4. AST/ALT, aspartate/alanine aminotransferase; ALP, alkaline phosphatase.