Ignite Creation Date:
2024-05-06 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05716295
Status:
TERMINATED
Last Update Posted:
2024-05-08
First Post:
2023-01-19
Brief Title:
A Dose EscalationExpansion Study of MDK-703 in Patients With Advanced or Metastatic Solid Tumors
Sponsor:
Medikine Inc
Organization:
Medikine Inc
Study Overview
Official Title:
A Phase 12 Open-Label Multicenter Study of MDK-703 as a Monotherapy and in Combination With Other Anti-Cancer Therapies in Patients With Advanced or Metastatic Solid Tumors ORCHID-1
Status:
TERMINATED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Corporate decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ORCHID-1
Brief Summary:
This is an open-label dose escalation and dose expansion study of MDK-703 as a monotherapy and in combination with other cancer therapies in adult study participants with advanced or metastatic solid tumors
Detailed Description:
This is a Phase 12 open-label multicenter dose escalation and dose expansion study evaluating MDK-703 in adult study participants with advanced or metastatic solid tumors This study will initially commence with dose escalation to evaluate the safetytolerability of MDK-703 as a monotherapy and in combination with other cancer therapies Once the monotherapy andor combination therapy maximum tolerated dose MTD optimal biological dose OBD andor recommended dose RD has been determined then dose expansion of MDK-703 may commence in select populations of interest The study will also evaluate the anti-tumor activity and pharmacokinetic PK and pharmacodynamic PD profiles of MDK-703 as a monotherapy and in combination with other cancer therapies
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