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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-30

Study Completion Date

2025-12-31

Brief Summary

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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

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Detailed Description

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Conditions

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Metastatic Solid Tumor

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part 1 Dose Escalation: PLN-101095 given as monotherapy and in combination with Pembrolizumab

Group Type EXPERIMENTAL

PLN-101095

Intervention Type DRUG

PLN-101095

Pembrolizumab

Intervention Type DRUG

Pembrolizumab

Part 2 Dose Expansion: PLN-101095 in combination with Pembrolizumab

Group Type EXPERIMENTAL

PLN-101095

Intervention Type DRUG

PLN-101095

Pembrolizumab

Intervention Type DRUG

Pembrolizumab

Interventions

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PLN-101095

Intervention Type DRUG

Pembrolizumab

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No