Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06600789
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-03
Brief Title:
A Modular Phase 12 Study with CT7439 in Participants with Solid Malignancies
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Modular Multi-Part Multi-Arm Phase 12 Study to Evaluate the Safety and Tolerability of CT7439 Alone and in Combination with Anticancer Treatments in Participants with Solid Malignancies
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This modular multi-part multi-arm Phase 12 FIH study allows the evaluation of the safety and tolerability of CT7439 dosed as a monotherapy and in combination with anticancer treatment in participants with solid malignancies
Detailed Description:
This study will initially evaluate CT7439 as a monotherapy in participants with locally advanced or metastatic solid malignancies ie Module 1 which includes dose escalation cohort Part A
- Part A of Module 1 a First-in Human dose escalation investigating the safety and tolerability of CT7439 to identify the minimum biologically active dose MBAD and either maximum tolerated dose MTD or maximum feasible dose MFD of CT7439 when dosed as monotherapy SRC consisting of study investigators and sponsor medical personnel will be formed to monitor the safety tolerability PK and PDc data during this part of the study In Part A cohorts maximum 6 will be opened sequentially following review from the SRC who will make recommendations on CT7439 dosage selection for subsequent cohorts Participants will continue to receive IMP until evidence of disease progression unacceptable toxicities the participant withdraws their informed consent or is withdrawn from the study or completion of the primary study analysis
Further cohorts of specific participant sub-populations may be initiated in Module 1 following approval of a protocol amendment
- Part A of Module 1 a First-in Human dose escalation investigating the safety and tolerability of CT7439 to identify the minimum biologically active dose MBAD and either maximum tolerated dose MTD or maximum feasible dose MFD of CT7439 when dosed as monotherapy SRC consisting of study investigators and sponsor medical personnel will be formed to monitor the safety tolerability PK and PDc data during this part of the study In Part A cohorts maximum 6 will be opened sequentially following review from the SRC who will make recommendations on CT7439 dosage selection for subsequent cohorts Participants will continue to receive IMP until evidence of disease progression unacceptable toxicities the participant withdraws their informed consent or is withdrawn from the study or completion of the primary study analysis
Further cohorts of specific participant sub-populations may be initiated in Module 1 following approval of a protocol amendment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None