Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06270706
Status:
RECRUITING
Last Update Posted:
2024-06-12
First Post:
2024-01-26
Brief Title:
A Phase 1 Study of PLN-101095 in Adults With Advanced or Metastatic Solid Tumors
Sponsor:
Pliant Therapeutics Inc
Organization:
Pliant Therapeutics Inc
Study Overview
Official Title:
A Phase 1a1b Multicenter Open-label Dose EscalationExpansion Study to Evaluate the Safety Tolerability Pharmacokinetics and Preliminary Evidence of Antitumor Activity of PLN-101095 as Monotherapy and in Combination With Pembrolizumab in Adult Participants With Advanced or Metastatic Solid Tumors Who Have Disease Progression While on Pembrolizumab
Status:
RECRUITING
Status Verified Date:
2024-02
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:
This is a Phase 1a1b dose-escalationexpansion consecutive-cohort open-label study to evaluate the safety tolerability PK PD and preliminary evidence of antitumor activity of PLN-101095 in combination with pembrolizumab the study treatment regimen in adult participants with advanced or metastatic solid tumors for which pembrolizumab is indicated but have documented disease progression refractory primary resistance or relapsed secondary resistance after at least 3 months from the start of treatment with pembrolizumab
The study will consist of 2 main parts
Part 1 Consecutive dose-escalation cohorts using a Bayesian optimal interval BOIN dose escalation design
Part 2 Dose-expansion cohorts using Simons 2-stage design
The study will consist of 2 main parts
Part 1 Consecutive dose-escalation cohorts using a Bayesian optimal interval BOIN dose escalation design
Part 2 Dose-expansion cohorts using Simons 2-stage design
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