Ignite Creation Date:
2024-05-06 @ 3:45 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04747470
Status:
TERMINATED
Last Update Posted:
2022-12-05
First Post:
2021-02-05
Brief Title:
Study to Assess the Effects of GS-3583 in Participants With Advanced Solid Tumors
Sponsor:
Gilead Sciences
Organization:
Gilead Sciences
Study Overview
Official Title:
A Phase 1b Dose Escalation Study to Evaluate the Safety Tolerability Pharmacokinetics and Preliminary Efficacy of GS-3583 a FLT3 Agonist Fc Fusion Protein in Subjects With Advanced Solid Tumors
Status:
TERMINATED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor decision to prematurely discontinue the study following an internal safety assessment of the molecule GS-3583
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is planned to be conducted in 2 parts Part 1 Dose Escalation and Part 2 Safety Run-In and Randomized Expansion
The primary objectives of Part 1 are 1 To characterize the safety and tolerability of GS-3583 as monotherapy in participants with advanced solid tumors 2 To determine the maximum tolerated dose MTD or recommended Phase 2 dose RP2D of GS-3583 as monotherapy in participants with advanced solid tumors
The primary objectives of Part 2 is to assess the safety and tolerability and to determine the RP2D of GS-3583 in combination with zimberelimab ZIM and platinum cisplatin or carboplatin 5-fluorouracil 5-FU chemotherapy in participants with head and neck squamous cell carcinoma HNSCC Cohort A or in combination with docetaxel in participants with non-small cell lung cancer NSCLC Cohort B
The primary objectives of Part 1 are 1 To characterize the safety and tolerability of GS-3583 as monotherapy in participants with advanced solid tumors 2 To determine the maximum tolerated dose MTD or recommended Phase 2 dose RP2D of GS-3583 as monotherapy in participants with advanced solid tumors
The primary objectives of Part 2 is to assess the safety and tolerability and to determine the RP2D of GS-3583 in combination with zimberelimab ZIM and platinum cisplatin or carboplatin 5-fluorouracil 5-FU chemotherapy in participants with head and neck squamous cell carcinoma HNSCC Cohort A or in combination with docetaxel in participants with non-small cell lung cancer NSCLC Cohort B
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