Testing PLN-101095 with pembrolizumab in adults with advanced 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)
This study is testing a new treatment called PLN-101095 combined with pembrolizumab to see if it can help adults with advanced solid tumors that haven't responded to previous treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 124 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Pliant Therapeutics, Inc. Industry-sponsored |
| Drugs / interventions | pembrolizumab |
| Locations | 6 sites (New Haven, Connecticut and 5 other locations) |
| Trial ID | NCT06270706 on ClinicalTrials.gov |
What this trial studies
This Phase 1 study evaluates the safety and effectiveness of PLN-101095 in combination with pembrolizumab for adults with advanced or metastatic solid tumors that have progressed after pembrolizumab treatment. The study consists of two parts: a dose-escalation phase to determine the optimal dose using a Bayesian design, followed by a dose-expansion phase to assess preliminary antitumor activity. Participants must have measurable lesions and no effective treatment options available. The goal is to find a potentially effective treatment for patients who have limited choices.
Who should consider this trial
Good fit: Ideal candidates are adults with advanced or metastatic solid tumors that have shown progression after at least three months of pembrolizumab treatment.
Not a fit: Patients with immune-related medical conditions that increase risk with pembrolizumab or those who have recently received other immunotherapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with advanced solid tumors who have exhausted other therapies.
How similar studies have performed: Other studies combining immunotherapies have shown promise, but this specific combination is novel and under investigation.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
New Haven, Connecticut and 5 other locations
- Yale University — New Haven, Connecticut, United States (Active_not_recruiting)
- Winship Cancer Institute of Emory University — Atlanta, Georgia, United States (Recruiting)
- South Texas Accelerated Research Therapeutics (START) — Grand Rapids, Michigan, United States (Recruiting)
- NEXT Austin — Austin, Texas, United States (Recruiting)
- University of Texas MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
- NEXT Virginia — Fairfax, Virginia, United States (Recruiting)
Study contacts
- Study coordinator: Pliant Therapeutics Medical Monitor
- Email: clintrials@pliantrx.com
- Phone: clintrials@pliantrx.com
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.