Clinical trial · Interventional
Study of PBF-999 in Solid Tumour Advanced Cancer
Phase I/Ib Trial of Single Agent PBF-999 in Solid Tumour Advanced Cancer
NCT03786484CI-TRIAL-00063479completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Multicentric phase I (dose escalation plus expansion) clinical trial of PBF-999 in patients with immunotherapy naïve and pretreated solid tumors to evaluate the safety, tolerability and preliminary efficacy of the compound
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 |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PBF-999 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- PBF-999 20 mg
- interventionNames
- Drug: PBF-999
- type
- EXPERIMENTAL
- label
- PBF-999 40 mg
- interventionNames
- Drug: PBF-999
- type
- EXPERIMENTAL
- label
- PBF-999 80 mg
- interventionNames
- Drug: PBF-999
- type
- EXPERIMENTAL
- label
- PBF-999 120 mg
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Advanced/metastatic histologically confirmed solid tumor * At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST 1.1). * Patients who has progressed to the standard therapy * ECOG performance status of 0/1 * Age greater than 18 years. * Adequate bone marrow, renal and hepatic function * Able and willing to give valid written consent for available archival tumor samples (not mandatory) and tumor biopsies before and during protocol (immune)therapy (not mandatory but highly recommended). * Prior immunotherapy is allowed Exclusion Criteria: * Participation in another clinical study with an investigational product during the last 4 weeks or 5 half-lifes prior to starting on treatment. * Symptomatic and/or untreated Brain Metastases * Pregnancy or breast feeding * Serious uncontrolled medical disorder or active infection that in the investigator's opinion would impair the patient's ability to receive study treatment. * Concurrent use of other anticancer approved or investigational agents is not allowed. * Active or prior documented autoimmune disease within the past 2 years. NOTE: Patients with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded. * Prior malignancy in past 2 years or as identified in Section 7.2 of this protocol * Patients receiving systemic steroids ≥ 10mg/day of prednisone or the equivalent * Concurrent administration of strong inhibitors or moderate inducers of CYP1A2 is not permitted; administration must be discontinued at least 7 days prior to initiating study drug administration.
References
Publications (0)
Data not yet available
No reference posted for this study.