Clinical trial · Interventional
FPT155 in Patients With Advanced Solid Tumors
A Phase 1a/1b Study of FPT155 in Patients With Advanced Solid Tumors
NCT04074759CI-TRIAL-00084996FPT155-001terminatedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor decision
Summary
Brief summary (as posted)
This study is a Phase 1 open-label, first-in-human, multicenter study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and activity of FPT155 as monotherapy in patients with advanced solid tumors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FPT155 | Biological | — | UNRESOLVED |
| pembrolizumab | Biological | Pembrolizumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- FPT155 monotherapy
- description
- The study consists of dose escalation and cohort expansions
- interventionNames
- Biological: FPT155
- type
- EXPERIMENTAL
- label
- FPT155 in combination with pembrolizumab
- description
- The study consists of dose escalation and cohort expansions
- interventionNames
- Biological: FPT155
- Biological: pembrolizumab
Primary outcomes (6)
- measure
- Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed solid tumors (except primary central nervous system tumors). For patients enrolled for treatment with FPT155+pembrolizumab: histologically confirmed non-small cell lung cancer not eligible for curative therapy. * Disease that is unresectable, locally advanced, or metastatic and has progressed following all standard treatments or is not appropriate for standard treatments * All patients must have at least one measurable lesion at baseline according to RECIST v1.1 * Availability of archival tumor tissue and consent to provide archival tumor for retrospective biomarker analysis, or consent to undergo a fresh tumor biopsy during screening * For patients participating in cohort expansions: consent to undergo a mandatory fresh tumor biopsy during screening and on treatment * ECOG performance status of 0 or 1 * Prior radiotherapy must be completed at least 2 weeks before first dose of study treatment administration. No radiopharmaceuticals (eg, strontium, samarium) within 8 weeks before first dose of study treatment administration. * Prior surgery that requires general anesthesia must be completed at least 14 days before first dose of study treatment * Adequate bone marrow, liver and kidney function Exclusion Criteria: * Uncontrolled or significant cardiac disease * Any uncontrolled medical condition or psychiatric disorder including infection, autoimmune disease, bleeding disorder or symptomatic involvement of the central nervous system * Treatment with any anti-cancer therapy or participation in another investigational drug or biologics trial within 28 days or ≤ 5 half-lives (whichever is shorter) * Patients who discontinue prior immune-modulating therapies (including regimens containing an immune agonist or a PD-L1/PD-1 antagonist) due to toxicity or have received treatment within 5 half lives or 90 days * Pregnancy or breastfeeding * For patients participating in cohort expansion: Prior treatment with a CTLA-4 antagonist, including ipilimumab and tremelimumab
References
Publications (0)
Data not yet available
No reference posted for this study.