A Phase 1 Study of PLN-101095 in Adults With Advanced or Metastatic Solid Tumors
Public ClinicalTrials.gov record NCT06270706. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT06270706
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 124 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 29, 2023
- Primary completion
- May 31, 2030
- Completion
- May 31, 2030
- Last update posted
- Aug 2, 2026
2023 – 2030
United States locations
- U.S. sites
- 12
- U.S. states
- 9
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Yale University | New Haven | Connecticut | 06511 | Active, not recruiting |
| Winship Cancer Institute of Emory University | Atlanta | Georgia | 30322 | Recruiting |
| South Texas Accelerated Research Therapeutics (START) | Grand Rapids | Michigan | 49546 | Recruiting |
| START New Jersey | East Brunswick | New Jersey | 08816 | Recruiting |
| START New York Long Island LLC | Lake Success | New York | 11042 | Recruiting |
| Carolina Cancer Research Center | Wilson | North Carolina | 27893 | Recruiting |
| NEXT Austin | Austin | Texas | 78758 | Recruiting |
| START Center for Clinical Research | Fort Worth | Texas | 76104 | Recruiting |
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | Recruiting |
| NEXT Houston | Houston | Texas | 77054 | Recruiting |
| START Mountain Region | West Valley City | Utah | 84119 | Recruiting |
| NEXT Virginia | Fairfax | Virginia | 22031 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06270706, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 2, 2026 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06270706 live on ClinicalTrials.gov.