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 range
18 Years
Sex
ALL
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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.
. 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)