High grade serous or endometroid ovarian cancer
Conditions
Brief summary
Part A: Safety and tolerability will be assessed by: 1) evaluation of DLTs and AEs (including but not limited to immunerelated AEs [irAEs]) during treatment and follow-up using NCI CTCAE v5.0 or American Society of Clinical Oncology (ASCO; for pneumonitis only) or American Society for Transplantation and Cellular Therapy (ASTCT; for CRS only). 2) Laboratory parameters. 3) Vital signs, physical examination, weight, 12-lead ECG and ECOG performance status, Part A: Evaluation of RP2D using safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and if available, anti-tumour activity data by Response Evaluation Criteria in Solid Tumours (RECIST) v1.1., Part B: The response to RP2D dose of THEO-260 will be assessed by ORR determined by tumour imaging according to RECIST v1.1.
Detailed description
Assess PK profile of THEO-260 in blood by qPCR., Assess shedding of THEO-260 in buccal, urine and faecal samples by qPCR., Assess systemic cytokine release following administration of THEO-260 by measurement of key markers in blood., Determine response to THEO-260 as assessed: 1) by tumour imaging according to RECIST v1.1. 2) Changes in CA-125. 3) Quality of Life Questionnaires, Part B: Safety and tolerability will be assessed by evaluation of DLTs and AEs (including but not limited to irAEs) during treatment and follow-up using NCI CTCAE v5.0 or ASCO (for pneumonitis only) or ASTCT (for CRS only);
Interventions
DRUGTHEO-260
Sponsors
Theolytics Limited
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part A: Safety and tolerability will be assessed by: 1) evaluation of DLTs and AEs (including but not limited to immunerelated AEs [irAEs]) during treatment and follow-up using NCI CTCAE v5.0 or American Society of Clinical Oncology (ASCO; for pneumonitis only) or American Society for Transplantation and Cellular Therapy (ASTCT; for CRS only). 2) Laboratory parameters. 3) Vital signs, physical examination, weight, 12-lead ECG and ECOG performance status, Part A: Evaluation of RP2D using safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and if available, anti-tumour activity data by Response Evaluation Criteria in Solid Tumours (RECIST) v1.1., Part B: The response to RP2D dose of THEO-260 will be assessed by ORR determined by tumour imaging according to RECIST v1.1. | — |
Secondary
| Measure | Time frame |
|---|---|
| Assess PK profile of THEO-260 in blood by qPCR., Assess shedding of THEO-260 in buccal, urine and faecal samples by qPCR., Assess systemic cytokine release following administration of THEO-260 by measurement of key markers in blood., Determine response to THEO-260 as assessed: 1) by tumour imaging according to RECIST v1.1. 2) Changes in CA-125. 3) Quality of Life Questionnaires, Part B: Safety and tolerability will be assessed by evaluation of DLTs and AEs (including but not limited to irAEs) during treatment and follow-up using NCI CTCAE v5.0 or ASCO (for pneumonitis only) or ASTCT (for CRS only); | — |
Countries
Spain
Outcome results
None listed