A Phase 1 Study of PLN-101095 in Adults With Advanced or Metastatic Solid Tumors (NCT06270706) | Clinical Trial Compass
RecruitingPhase 1
A Phase 1 Study of PLN-101095 in Adults With Advanced or Metastatic Solid Tumors
United States124 participantsStarted 2023-08-30
Plain-language 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 with accelerated titration
* Part 2: Dose-expansion cohorts using Simon's 2-stage design
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Safety and tolerability of PLN-101095 in combination with pembrolizumab in Parts 1 and 2
Timeframe: First dose to 35 days
2
Safety and tolerability of PLN-101095 in combination with pembrolizumab in Parts 1 and 2
Timeframe: Day 1 until 16 weeks after end of study treatment regimen
3
Anti-tumor activity of PLN-101095 in combination with pembrolizumab in Part 2
Timeframe: First dose to disease progression or death from any cause, whichever occurs first.
4
Anti-tumor activity of PLN-101095 in combination with pembrolizumab in Part 2
Timeframe: First dose to disease progression or death from any cause, whichever occurs first.
✕. 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)