Ignite Creation Date:
2024-07-17 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06480552
Status:
RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-06-10
Brief Title:
An Open-label Dose EscalationExpansion Trial to Evaluate the Safety and Anti-tumor Activity of TEV-56278 Alone or in Combination With Pembrolizumab in Participants With Advanced or Metastatic Solid Tumors
Sponsor:
Teva Branded Pharmaceutical Products RD Inc
Organization:
Teva Branded Pharmaceutical Products RD Inc
Study Overview
Official Title:
A Phase 1a1b Open-Label Multicenter Dose Escalation and Dose Expansion Trial to Evaluate the Safety and Activity of TEV-56278 as a Monotherapy and in Combination With Pembrolizumab in Participants With Selected Locally Advanced or Metastatic Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-09
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:
The primary objectives of this trial are to
Characterize the safety and tolerability of TEV-56278
Determine the Recommended Phase 2 Dose RP2D
Evaluate antitumor activity of TEV-56278
Determine the safety and tolerability of TEV-56278 in combination with pembrolizumab
Determine a RP2D of TEV-56278 in combination with pembrolizumab
The secondary objectives of this trial are to
Characterize the serum pharmacokinetics of TEV-56278
Evaluate the antitumor activity of TEV-56278
Determine the safety and tolerability of TEV-56278
Evaluate other measures of antitumor activity of TEV-56278
Evaluate anti-tumor activity
Participants will be treated up to 12 months with a follow-up period of up to 12 months after last infusion The total duration of the trial will be up to 25 months for individual participants
Characterize the safety and tolerability of TEV-56278
Determine the Recommended Phase 2 Dose RP2D
Evaluate antitumor activity of TEV-56278
Determine the safety and tolerability of TEV-56278 in combination with pembrolizumab
Determine a RP2D of TEV-56278 in combination with pembrolizumab
The secondary objectives of this trial are to
Characterize the serum pharmacokinetics of TEV-56278
Evaluate the antitumor activity of TEV-56278
Determine the safety and tolerability of TEV-56278
Evaluate other measures of antitumor activity of TEV-56278
Evaluate anti-tumor activity
Participants will be treated up to 12 months with a follow-up period of up to 12 months after last infusion The total duration of the trial will be up to 25 months for individual participants
Detailed Description:
None
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