Ignite Creation Date:
2024-05-06 @ 1:21 PM
Last Modification Date:
2024-10-26 @ 1:13 PM
Study NCT ID:
NCT04009681
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-05
First Post:
2019-06-27
Brief Title:
A Study Evaluating Safety and Therapeutic Activity of THOR-707 in Adult Subjects With Advanced or Metastatic Solid Tumors THOR-707-101
Sponsor:
Synthorx Inc a Sanofi company
Organization:
Synthorx Inc a Sanofi company
Study Overview
Official Title:
An Open-Label Multicenter Phase 12 Dose Escalation and Expansion Study of THOR-707 as a Single Agent and as a Combination Therapy in Adult Subjects With Advanced or Metastatic Solid Tumors
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
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:
HAMMER
Brief Summary:
Primary Objectives
Evaluate the safety and tolerability of THOR-707 as a single agent and as a combination therapy identify Dose Limiting Toxcitiy DLTs in Cohorts A B C D and G and adverse events AEsserious adverse event SAE profile in Cohorts A B C D E F and G
Define the Maximium Tolerated Dose MTD andor the Recommended Phase 2 Dose RP2D of THOR-707 as a single agent and as a combination therapy Cohorts A B C D and G
Evaluate preliminary anti-tumor activity of THOR-707 as a single agent by determination of the objective response rate ORR defined according to the Response Evaluation Criteria in Solid Tumors RECIST Version 11 Cohort H only
Secondary Objectives
Evaluate preliminary anti-tumor activity of THOR-707 as a single agent and as a combination therapy by determination of the objective response rate ORR defined according to the Response Evaluation Criteria in Solid Tumors RECIST Version 11 Cohorts A B C D E F and G
Determine time to response TTR duration of response DOR progression-free survival PFS overall survival OS disease control rate DCR and clinical benefit rate CBR of THOR-707 as a single agent and as a combination therapy
Evaluate the safety and tolerability of THOR-707 monotherapy QWQ2W AEserious adverse event SAE profile Cohort H only
Evaluate the safety and tolerability of THOR-707 as a single agent and as a combination therapy identify Dose Limiting Toxcitiy DLTs in Cohorts A B C D and G and adverse events AEsserious adverse event SAE profile in Cohorts A B C D E F and G
Define the Maximium Tolerated Dose MTD andor the Recommended Phase 2 Dose RP2D of THOR-707 as a single agent and as a combination therapy Cohorts A B C D and G
Evaluate preliminary anti-tumor activity of THOR-707 as a single agent by determination of the objective response rate ORR defined according to the Response Evaluation Criteria in Solid Tumors RECIST Version 11 Cohort H only
Secondary Objectives
Evaluate preliminary anti-tumor activity of THOR-707 as a single agent and as a combination therapy by determination of the objective response rate ORR defined according to the Response Evaluation Criteria in Solid Tumors RECIST Version 11 Cohorts A B C D E F and G
Determine time to response TTR duration of response DOR progression-free survival PFS overall survival OS disease control rate DCR and clinical benefit rate CBR of THOR-707 as a single agent and as a combination therapy
Evaluate the safety and tolerability of THOR-707 monotherapy QWQ2W AEserious adverse event SAE profile Cohort H only
Detailed Description:
The study duration per participant is approximately 24 months inclusive of follow-up Cohorts A B C and D have been completed
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1298-7281 | OTHER | None | None |
| 2023-508422-95-00 | OTHER | EMA | None |