Clinical efficacy (ORR per RECIST 1.1) and volumetric analysis
| Dose level | Patient no. | Pain improvement | RECIST at the last assessment (3 months after first dose) | Volumetric change, % change (baseline/study end; cm3) |
| 1 | 2 | No | PD (clin. deterioration) | Not done |
| 3 | No | PD (clin. deterioration) | Not done | |
| 4 | No | PD (clin. deterioration) | Not done | |
| 2 | 5 | No | PD | +100 (15.3/30) |
| 6 | No | PD | +63.5 (7.4/12.1) | |
| 7 | Yes | SD | +230 (57/188) | |
| 8 | No | SD | Not done (too small to measure) | |
| 3 | 9 | Yes | PR | −66 (2146/724) |
| 10 | No | PD | +75 (0.8/1.4) | |
| 11 | No | PD | +212 (10.7/33.4) | |
| 12 | Yes | SD | −41 (129/76) | |
| 13 | Yes | SD | +27 (15.5/19.7) | |
| 14 | No | PD (SD per RECIST but with clin. deterioration) | +25 (11.1/13.9) | |
| All dose levels | n=13 | Yes 4 out of 13 No 9 out of 13 | 1 PR 4 SD 8 PD | Two with volumetric shrinkage |
Summary of clinical efficacy results in all patients and per dose level, with a comparison of ORR per RECIST 1.1 and retrospective exploratory volumetric analysis.
ORR, objective response rate; PD, progressive disease; PR, partial response; RECIST, Response Evaluation Criteria in Solid Tumors; SD; stable disease