Table 2:
Description of dose escalation and patient disposition
| Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 | Cohort 5 | Expansion Cohort | Overall n (%) | |
|---|---|---|---|---|---|---|---|
| Dose of Ipafricept (Q3W) |
5 mg/kg n (%) | 10 mg/kg n (%) | 2 mg/kg n (%) | 4 mg/kg n (%) | 6 mg/kg n (%) | 6 mg/kg n (%) | |
| Patients Enrolled | 3 | 4 | 8 | 9 | 6 | 7 | 37 |
| 3 (100.0) | 4 (100.0) | 8 (100.0) | 9 (100.0) | 6 (100.0) | 7 (100.0) | 37 (100.0) | |
| Overall Reason for Ending Study Treatmentd | |||||||
| Lost to Follow-Up | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrawal of Consent | 1(33.3) | 0 | 0 | 0 | 0 | 1(14.3) | 2(5.4) |
| Death | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Disease Progression | 0 | 0 | 5 (62.5) | 5 (55.6) | 2 (33.3) | 1 (14.3) | 13 (35.1) |
| Investigator Decision Based on Patient’s Best Interest | 1(33.3) | 0 | 0 | 1(11.1) | 0 | 0 | 2(5.4) |
| Patient completed planned treatment cycles | 1 (33.3) | 4 (100.0) | 1(12.5) | 0 | 0 | 0 | 6(16.2) |
| Clinical/symptomatic progression | 0 | 0 | 1 (12.5) | 0 | 1(16.7) | 0 | 2(5.4) |
| Study terminated by Sponsor | 0 | 0 | 1 (12.5) | 3(33.3) | 3(50.0) | 5(71.4) | 12(32.4) |
| Total Number of Ipafricept Infusion Administered per Patient | |||||||
| Mean (SD) | 4.3 (0.58) | 2.0 (0.82) | 14.4 (8.90) | 14.0 (9.60) | 9.8 (2.32) | 4.7 (1.80) | 9.6 (7.78) |
| Median | 4.0 | 2.0 | 15.0 | 12.0 | 10.5 | 4.0 | 7.0 |
| Total Number of Paclitaxel Infusions Administered per Patient | |||||||
| Mean (SD) | 5.3 (0.58) | 6.0 (0.00) | 6.0 (0.00) | 5.7 (1.80) | 5.2 (2.04) | 4.7 (1.80) | 5.5 (1.45) |
| Median | 5.0 | 6.0 | 6.0 | 6.0 | 6.0 | 4.0 | 6.0 |
| Total Number of Carboplatin Infusions Administered per Patient | |||||||
| Mean (SD) | 5.3 (0.58) | 8.0 (4.00) | 5.5 (1.41) | 7.0 (3.97) | 7.5 (3.67) | 6.4 (6.08) | 6.6 (3.75) |
| Median | 5.0 | 6.0 | 6.0 | 6.0 | 6.0 | 4.0 | 6.0 |
SD= standard deviation