Tests PLN-101095 with pembrolizumab in adults with advanced solid tumors
Tests PLN-101095, alone and with pembrolizumab, in adults with solid tumors that progressed on immunotherapy.
Plain-language title generated from the registry record
Registry title: A Phase 1 Study of PLN-101095 in Adults With Advanced or Metastatic Solid Tumors
Key facts
- Where
- Barcelona, Logroño, and Madrid, SpainSee the 6 sites
- Phase
- Phase 1
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with an advanced or spread solid tumor whose cancer grew while on an anti-PD-1 or anti-PD-L1 treatment.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Advanced or metastatic solid tumor, confirmed by tissue or cell tests, with at least 1 measurable lesion by RECIST v1.1 and estimated survival of at least 3 months.
- Earlier treatment
- Must have had at least 12 weeks of continuous anti-PD-1 or anti-PD-L1 treatment, alone or with other cancer therapies, and then the disease progressed on it or within 12 weeks after the last dose. For Part 2 only: earlier benefit shown as CR or PR at any time, or SD lasting at least 6 months.
Main reasons for not taking part
- Immune-related medical conditions that raise risk with pembrolizumab
- Another cancer that is progressing or needed active treatment in the past 2 years
- Known active brain or leptomeningeal metastases
- Active autoimmune disease needing systemic treatment in the past 2 years
- Immunodeficiency or systemic steroids above 10 mg/day
Read by machine on 9 November 2026.
Where in Spain
- Hospital Universitari Quirónsalud (NEXT Barcelona)Barcelona, SpainTaking people
- START Barcelona Hospital HM Nou DelfosBarcelona, SpainTaking people
- START Center for Cancer Research - La RiojaLogroño, SpainTaking people
- START Madrid / Centro Integral Oncologico Clara CampalMadrid, SpainTaking people
- START Madrid / Hospital Universitario Fundacion Jimenez DiazMadrid, SpainTaking people
- University Hospital Quironsalud Madrid (NEXT Madrid)Madrid, SpainTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Pliant Therapeutics, Inc.
- Trial code
- NCT06270706
- Record updated
- 2 October 2026
- Original description
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.Read full original descriptionShow less
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)
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
Inclusion: 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: Any immune-related medical conditions that would put participants at greater risk when receiving pembrolizumab; 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 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; Has a known additional malignancy that is progressing or has required active treatment within the past 2 years; Has an active autoimmune disease that has required systemic treatment in the past 2 years; Has significant cardiac disease; Has an active infection requiring systemic therapy (including uncontrolled HIV, Hepatitis B and C); Has known active CNS metastases (brain and/or leptomeningeal metastases).