Ignite Creation Date:
2024-05-06 @ 7:15 PM
Last Modification Date:
2024-10-26 @ 3:03 PM
Study NCT ID:
NCT05940844
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-07-11
First Post:
2023-06-16
Brief Title:
Study of OB-002 in Patients With Refractory Metastatic Cancer
Sponsor:
Orion Biotechnology Polska Sp z oo
Organization:
Orion Biotechnology Polska Sp z oo
Study Overview
Official Title:
A Phase 1b Open-label Non-randomized Trial for the Assessment of Safety Tolerability and Pharmacokinetics of OB-002 as a Monotherapy in Patients With Refractory Metastatic Colorectal Pancreatic Gastric Breast or Urothelial Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an open-label non-randomized trial with OB-002 monotherapy dose escalation followed by a dose expansion in patients with metastatic colorectal pancreatic gastric breast or urothelial cancer who have progressed on two or more treatment regimens
Detailed Description:
The dose escalation will use a conventional 33 approach at a minimum of four planned dose levels 025 05 10 and 15 mgkg to establish a maximum tolerated dose MTD Additional dose levels may be investigated if PK pharmacodynamic PD safety and efficacy data indicate higher dose levels may be appropriate The first patient - sentinel patient - at each dose level will be observed for three days before additional patients can be dosed within the same dose level
The patients will be dosed once weekly Days 1 8 15 and 22 over a 4-week treatment cycle with a 28-day dose-limiting toxicity DLT observation period After a full cohort has completed Day 28 assessments there will be a pause for safety evaluation conducted by the Safety Monitoring Committee SMC Once safety data have been reviewed the SMC will make their recommendations to Orion who will decide whether to proceed to dosing the next dose cohort Screening may continue during the SMC pause
Once all patients in the highest planned cohort 15 mgkg OB 002 have completed Day 28 assessments safety PK receptor occupancy RO and tolerability data will be reviewed to determine which dose level should be expanded or whether an additional dose level is needed The expanded cohort will enrol 6 patients at the identified dose level
Patients may remain on treatment until disease progression with a follow-up FU period of up to 12 months All adverse events AEs and non-invasive tumor assessments will be documented throughout the FU period to characterize the objective response rate ORR and progression-free survival PFS Patients that do not complete the DLT observation period for non-DLT reasons will be replaced
The patients will be dosed once weekly Days 1 8 15 and 22 over a 4-week treatment cycle with a 28-day dose-limiting toxicity DLT observation period After a full cohort has completed Day 28 assessments there will be a pause for safety evaluation conducted by the Safety Monitoring Committee SMC Once safety data have been reviewed the SMC will make their recommendations to Orion who will decide whether to proceed to dosing the next dose cohort Screening may continue during the SMC pause
Once all patients in the highest planned cohort 15 mgkg OB 002 have completed Day 28 assessments safety PK receptor occupancy RO and tolerability data will be reviewed to determine which dose level should be expanded or whether an additional dose level is needed The expanded cohort will enrol 6 patients at the identified dose level
Patients may remain on treatment until disease progression with a follow-up FU period of up to 12 months All adverse events AEs and non-invasive tumor assessments will be documented throughout the FU period to characterize the objective response rate ORR and progression-free survival PFS Patients that do not complete the DLT observation period for non-DLT reasons will be replaced
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None