A Phase Ia/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

Study Identifier:
PLN-101095-ONC-101
CT.gov Identifier:
NCT06270706
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Recruiting

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Study 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\ To assess the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary antitumor activity of PLN-101095 in patients with solid tumors that are resistant to immune checkpoint inhibitors (ICIs). To evaluate the safety, tolerability and pharmacokinetics of PLN-101095 as monotherapy and in combination with pembrolizumab in patients with advanced or metastatic solid tumors progressing on treatment with pembrolizumab Dose-escalation will be determined by a Bayesian optimal interval dose escalation design with accelerated titration (n = 1) permitted for dose levels 1 and 2 A minimum of 3 participants will be accrued to dose levels 3 to 5. Following the dose-escalation cohorts, dose-expansion cohorts using a Simon’s 2-stage design are planned. To evaluate the safety and tolerability of PLN-101095, administered first as monotherapy to re-sensitize participants’ tumors to pembrolizumab, and subsequently in combination with pembrolizumab

To evaluate the safety, tolerability, pharmacokinetics, and preliminary evidence of antitumor activity of PLN-101095, as monotherapy and in combination with pembrolizumab, in patients with immune checkpoint inhibitor (ICI)-refractory advanced or metastatic solid tumors.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Solid Tumor
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
    N/A
    Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    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

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Midwest
    Grand Rapids, MI, United States, 49546
    Investigator
    Manish Sharma
    Status
    Recruiting
    Condition(s) Treated at Site
    Solid Tumor