NCT06270706 · Pliant Therapeutics, Inc.
A Phase 1 Study of PLN-101095 in Adults With Advanced or Metastatic Solid Tumors
What this study is about
This is a Phase 1a/1b, gradually increasing doses/expansion, consecutive-group of participants, where both patients and doctors know the treatment given 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 gradually increasing doses cohorts using a Bayesian optimal interval (BOIN) gradually increasing doses design with accelerated titration * Part 2: Dose-expansion cohorts using Simon's 2-stage design
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Has histologically or cytologically confirmed advanced or metastatic solid tumor
- Have received ≥12 weeks of continuous anti-PD-1 or anti-PD-L1 treatment administered as monotherapy or in combination with other anticancer therapies
- Have demonstrated documented prior clinical benefit, defined as CR or PR at any time during treatment, or SD lasting ≥6 months (Part 2 only)
- Must have subsequently developed radiographic disease progression while receiving anti-PD-1 or anti-PD-L1 treatment or within ≤12 weeks after the last dose of such treatment
- At least 1 measurable lesion, as defined by RECIST v1.1
- Estimated survival of ≥3 months
- Have adequate bone marrow and organ function.
- A female participant is eligible to participate if she is not pregnant, not breastfeeding
Exclusion criteria
- Any immune-related medical conditions that would put participants at greater risk when receiving pembrolizumab
- Has a known additional malignancy that is progressing or has required active treatment within the past 2 years
- Has received prior radiotherapy within 2 weeks for palliative bone-directed therapy and 4 weeks for all other radiotherapy
- Has undergone major surgery within 4 weeks prior to the first dose of study treatment or has not adequately recovered from surgery or related complications
- Has a diagnosis of immunodeficiency or use of systemic steroids \>10 mg/day
- Has an active autoimmune disease that has required systemic treatment in the past 2 years
- Has known active CNS metastases (brain and/or leptomeningeal metastases)
- Has significant cardiac disease
- Has an active infection requiring systemic therapy (including uncontrolled HIV, Hepatitis B and C)
- Has received a live or live-attenuated vaccine within 30 days or a non-live vaccine within 7 days prior to the first dose of PLN-101095
Where
- New Haven, Connecticut
- Atlanta, Georgia
- Grand Rapids, Michigan
- Austin, Texas
- Houston, Texas
- Fairfax, Virginia
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 20, 2026 · Source of record for eligibility and locations