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

Metastatic Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06270706
• Other study ID #: PLN-101095-ONC-101
• Status: Recruiting
• Phase: Phase 1
• Start date: August 30, 2023
• Est. completion date: December 2025

Study information

• Verified date: February 2024
• Source: Pliant Therapeutics, Inc.
• Contact: Pliant Therapeutics Medical Monitor
• Phone: clintrials@pliantrx.com
• Email: clintrials[@]pliantrx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 77
• Est. completion date: December 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Has histologically or cytologically confirmed advanced solid tumor

2. Has an advanced or metastatic solid tumor (for which pembrolizumab is indicated) and have evidence of disease progression after treatment with pembrolizumab.

3. At least 1 measurable lesion, as defined by RECIST v1.1

4. Estimated survival of =3 months

5. No effective therapeutic options available (eg, has received standard of care or is intolerant of, refuses, or is not eligible for standard of care antineoplastic therapy)

Exclusion Criteria:

1. Any immune-related medical conditions that would put participants at greater risk when receiving pembrolizumab

2. Previous treatment with pembrolizumab <21 days prior to the first dose of combination therapy of pembrolizumab and PLN-101095

3. Received an immunotherapy other than pembrolizumab in the last 4 weeks prior to the first dose of PLN-101095

4. Received radiotherapy (RT) within 1 week for palliative bone-directed therapy and 4 weeks for all other types, prior to the first dose of PLN-101095

5. Received chemotherapy or other targeted therapies within 2 weeks prior to the first dose of PLN-101095

6. Received a cell therapy within the last 12 months prior to the first dose of PLN-101095

7. Known active central nervous system (CNS) metastases (brain and/or leptomeningeal metastases)

8. Pregnant or lactating female participant

Related Conditions & MeSH terms

• Metastatic Solid Tumor
• Neoplasms

Intervention

Drug:
• PLN-101095
PLN-101095
• Pembrolizumab
Pembrolizumab

Locations

Country	Name	City	State
United States	NEXT Austin	Austin	Texas
United States	NEXT Virginia	Fairfax	Virginia
United States	South Texas Accelerated Research Therapeutics (START)	Grand Rapids	Michigan
United States	University of Texas MD Anderson Cancer Center	Houston	Texas
United States	Yale University	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Pliant Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants with treatment-emergent adverse events and serious adverse events per CTCAE Version 5.0.		Signing ICF until 16 weeks after end of study treatment regimen
Primary	Number of participants with a Dose Limiting Toxicity (DLT) defined as toxicities that meet predefined severity criteria, assess as having a suspected relationship to study drug, unrelated to disease, inter-current illness, or concomitant medications.		First dose to 35 days
Secondary	Maximum observed plasma concentration (Cmax) to characterize the plasma pharmacokinetics (PK).		First dose until 10 weeks
Secondary	Time to maximum observed concentration (Tmax) to characterize the plasma pharmacokinetics (PK).		First dose until 10 weeks
Secondary	Area under the concentration-time curve over a dosing interval (AUC0-t) to characterize the plasma pharmacokinetics (PK).		First dose until 10 weeks
Secondary	Disease control rate (DCR) is defined by the proportion of participants who maintain disease control (iCR, iPR or iSD) per iRECIST Version 1.1.		Day 1 until end of study treatment regimen
Secondary	Objective response rate (ORR) is defined by the proportion of participants with an iCR or iPR per iRECIST Version 1.1.		Day 1 until end of study treatment regimen