Ignite Creation Date:
2024-05-06 @ 3:48 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04762225
Status:
TERMINATED
Last Update Posted:
2022-12-06
First Post:
2021-02-16
Brief Title:
RPTR-168 in Patients With Human Papillomavirus Strain 16 HPV-16 E6E7 Positive Tumors and Melanoma
Sponsor:
Repertoire Immune Medicines
Organization:
Repertoire Immune Medicines
Study Overview
Official Title:
A Phase 12 Open-Label Multi-Center Study to Characterize the Safety and Tolerability of RPTR-168 in Patients With RelapsedRefractory HPV-16 E6E7 Positive Tumors and Melanoma
Status:
TERMINATED
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Development program terminated
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to assess the safety and tolerability of escalating doses of RPTR-168 as a monotherapy in patients with HPV-16 E6E7 positive tumors HNSCC cervical and melanoma
Detailed Description:
This is a phase 12 open-label first-in-human multi-center study to characterize the safety and tolerability of RPTR-168 administered iv as a monotherapy in patients with relapsedrefractory metastatic or locally-advanced HPV-16 E6E7 positive tumors and melanoma
The study will include 2 dosing periods A Dose Escalation Phase 1 followed by an Expansion Phase 2
The study will include 2 dosing periods A Dose Escalation Phase 1 followed by an Expansion Phase 2
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