Advanced or Metastatic Solid Tumor study: PLN-101095 vs Pembrolizumab
Official title A Phase 1 Study of PLN-101095 in Adults With Advanced or Metastatic Solid Tumors
ClinicalTrials.gov ID: NCT06270706
What this study is testing
What is PLN-101095?
an investigational oral drug being studied as a potential treatment for advanced or metastatic solid tumors in combination with pembrolizumab
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to find the safest dose of the new drug and check if it helps shrink tumors in people whose cancer grew back after prior treatment.
- Who it's for
- Adults with advanced or metastatic solid tumors that have progressed or relapsed after at least three months of pembrolizumab treatment.
- What's involved
- Participants will receive the new drug PLN-101095 along with pembrolizumab and undergo regular medical tests to monitor safety and how the body handles the drugs.
- Time commitment
- The study involves two main parts: first, testing different doses to find the right level, and second, expanding to more people to see if the treatment works.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- At least 1 measurable lesion, as defined by RECIST v1.1
You likely can't join if
- 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...
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Washington D.C., District of Columbia, United States
- Atlanta, Georgia, United States
- Grand Rapids, Michigan, United States
- St Louis, Missouri, United States
- East Brunswick, New Jersey, United States
- New Brunswick, New Jersey, United States
- Lake Success, New York, United States
- Wilson, North Carolina, United States
- Sioux Falls, South Dakota, United States
- Nashville, Tennessee, United States
- Austin, Texas, United States
- Fort Worth, Texas, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
- West Valley City, Utah, United States
- Fairfax, Virginia, United States
- Edmonds, Washington, United States
- Barcelona, Barcelona, Spain
- Logroño, La Rioja, Spain
- Madrid, Madrid, Spain
+ 1 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Washington D.C., District of Columbia, United States; Atlanta, Georgia, United States; Grand Rapids, Michigan, United States; St Louis, Missouri, United States; East Brunswick, New Jersey, United States; New Brunswick, New Jersey, United States and 15 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.