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RecruitingPhase 1

A Phase 1 Study of PLN-101095 in Adults With Advanced or Metastatic Solid Tumors

A Phase 1a/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 an Immune Checkpoint Inhibitor (FORTIFY)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This early-stage study tests PLN-101095 with pembrolizumab to learn about safety, doses, and effects on cancer. It is for adults with solid tumors that are advanced or have spread, whose cancer worsened or came back after at least 3 months of pembrolizumab treatment.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have an advanced solid tumor or one that has spread, confirmed by a tissue or cell test.
  • Have had at least 12 weeks of ongoing anti-PD-1 or anti-PD-L1 treatment, medicines that help the immune system fight cancer.
  • For Part 2 only: During earlier treatment, the cancer shrank or disappeared, or stayed stable for at least 6 months.
  • Scans show the cancer later worsened during anti-PD-1 or anti-PD-L1 treatment or within 12 weeks after the last dose.
  • Have at least one tumor that can be measured using the study's rules.
  • Are expected to live at least 3 months.
  • Have organs and bone marrow, which makes blood cells, that work well enough.
  • If female, are not pregnant or breastfeeding.

Who can't join

  • Have an immune system condition that makes pembrolizumab unsafe, a weakened immune system, or use steroids that act throughout the body at more than 10 mg a day.
  • Have another cancer that is growing or needed treatment in the past 2 years.
  • Had radiation for bone symptom relief within 2 weeks, or any other radiation within 4 weeks.
  • Had major surgery within 4 weeks before the first study dose, or have not recovered well enough from surgery or its complications.
  • Have an autoimmune disease, where the immune system attacks the body, that needed treatment acting throughout the body in the past 2 years.
  • Have active cancer spread to the brain or its surrounding tissue, or have serious heart disease.
  • Have an active infection needing treatment that acts throughout the body, including uncontrolled HIV or hepatitis B or C.
  • Had a live or weakened-live vaccine within 30 days, or a non-live vaccine within 7 days, before the first PLN-101095 dose.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. Has histologically or cytologically confirmed advanced or metastatic solid tumor 2. Have received ≥12 weeks of continuous anti-PD-1 or anti-PD-L1 treatment administered as monotherapy or in combination with other anticancer therapies 3. Have demonstrated documented prior clinical benefit, defined as CR or PR at any time during treatment, or SD lasting ≥6 months (Part 2 only) 4. 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 5. At least 1 measurable lesion, as defined by RECIST v1.1 6. Estimated survival of ≥3 months 7. Have adequate bone marrow and organ function. 8. A female participant is eligible to participate if she is not pregnant, not breastfeeding Exclusion Criteria: 1. Any immune-related medical conditions that would put participants at greater risk when receiving pembrolizumab 2. Has a known additional malignancy that is progressing or has required active treatment within the past 2 years 3. Has received prior radiotherapy within 2 weeks for palliative bone-directed therapy and 4 weeks for all other radiotherapy 4. 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 5. Has a diagnosis of immunodeficiency or use of systemic steroids \>10 mg/day 6. Has an active autoimmune disease that has required systemic treatment in the past 2 years 7. Has known active CNS metastases (brain and/or leptomeningeal metastases) 8. Has significant cardiac disease 9. Has an active infection requiring systemic therapy (including uncontrolled HIV, Hepatitis B and C) 10. 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

Study sites (16)

CT

GA

MI

MO

NC

NJ

NY

SD

TN

TX

UT

VA