NCT06270706

A Phase 1 Study of PLN-101095 in Adults With Advanced or Metastatic Solid Tumors

A Phase 1a/1b Multicenter, Open-label Dose Escalation/Expansion 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: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 77 (estimated)
• Sponsor: Pliant Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1a/1b, dose-escalation/expansion, 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 Simon's 2-stage design

Conditions

• Metastatic Solid Tumor

Interventions

Type	Name	Description
DRUG	PLN-101095	PLN-101095
DRUG	Pembrolizumab	Pembrolizumab

Timeline

• Start date: 2023-08-30
• Primary completion: 2025-06-01
• Completion: 2025-12-01
• First posted: 2024-02-21
• Last updated: 2024-06-12

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study