54 10.4 Publication Policy ....................................................................................................................... 54 11.0 ETHICAL CONSIDERATIONS .................................................................................................. 54 11.1 Informed Consent ...................................................................................................................... 54 11.2 Institutional Review Board/Independent Ethics Committee .................................................... 54 11.3 Patient Privacy ........................................................................................................................... 55 12.0 DATA HANDLING AND RECORD KEEPING ............................................................................. 55 12.1 Data to be Entered Directly in the Case Report Form ............................................................... 55 12.2 Recording of Data ...................................................................................................................... 55 12.3 Study Records ............................................................................................................................ 55 13.0 REFERENCES ........................................................................................................................ 56 APPENDIX I - ECOG Performance Status ............................................................................................ 58 APPENDIX II - Common Terminology Criteria for Adverse Events (CTCAE) v5.0 .................................. 59 APPENDIX III Summary of Changes .................................................................................................... 60 List of In- text Tables Table 1: HS-130/HS -110 Dose Administration Guidelines .......................................................................... 31 Table 2: HS-130/HS -110 Dose Levels .......................................................................................................... 32 Table 3: Schedule of Assessments .............................................................................................................. 36 Table 4: Time point response: Patients with target (+/ - non-target) disease ............................................ 48 Table 5: Time point response: Patients with non-target disease only ....................................................... 49 Table 6: Best overall response when confirmation of CR and PR required ................................................ 49 List of In- text Figures Figure 1: pcDNA3.4 OX40L-Ig Vector Map .................................................................................................. 18 Figure 2: Schematic diagram showing the structure of HS -110 .................................................................