Ignite Creation Date:
2024-05-06 @ 3:32 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04666688
Status:
RECRUITING
Last Update Posted:
2024-04-02
First Post:
2020-11-25
Brief Title:
LYT-200 Alone and in Combination With Chemotherapy or Tislelizumab in Patients With Locally Advanced or Metastatic Solid Tumors
Sponsor:
PureTech
Organization:
PureTech
Study Overview
Official Title:
A Phase 12 Open-label Multi-center Study of the Safety Pharmacokinetics and Anti-tumor Activity of LYT-200 as a Single Agent and in Combination With Chemotherapy or Tislelizumab in Patients With Locally Advanced or Metastatic Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-04
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:
A Phase 12 Open-label Multi-center Study of the Safety Pharmacokinetics and Anti-tumor Activity of LYT-200 Alone and in Combination with Chemotherapy or Tislelizumab in Patients with Metastatic Solid Tumors
Detailed Description:
This is an open-label uncontrolled multicenter Phase 12 study with a dose escalation phase Part 1 and a cohort expansion phase Part 2 in patients with relapsedrefractory metastatic solid tumors
Part 1 Dose Escalation Phase_Single Agent A dose-finding study will be conducted using a continuous reassessment method CRM to establish dose-limiting toxicities DLTs and the recommended Phase 2 dose RP2D
Part 1 Dose Escalation Phase_Combination A dose-finding combination study with chemotherapy or tislelizumab will be conducted using a 42 study design to establish dose-limiting toxicities DLTs and the recommended Phase 2 dose RP2D
Part 2 The second part of the protocol will be a dose expansion in bothor either single agent or combination based on the RP2D determined in Part 1 in patients with metastaticadvanced solid tumors
Part 1 Dose Escalation Phase_Single Agent A dose-finding study will be conducted using a continuous reassessment method CRM to establish dose-limiting toxicities DLTs and the recommended Phase 2 dose RP2D
Part 1 Dose Escalation Phase_Combination A dose-finding combination study with chemotherapy or tislelizumab will be conducted using a 42 study design to establish dose-limiting toxicities DLTs and the recommended Phase 2 dose RP2D
Part 2 The second part of the protocol will be a dose expansion in bothor either single agent or combination based on the RP2D determined in Part 1 in patients with metastaticadvanced solid tumors
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