A Phase 1 interventional study of PBF-999 in Cancer, sponsored by Palobiofarma SL. Completed at 1 site in Spain. Per ClinicalTrials.gov, last updated 2023-01-26.
Sponsored by Palobiofarma SL · Phase 1, Interventional, and Treatment
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
The phase I dose escalations will be conducted utilizing the standard 3+3 dose escalation method. Pharmacokinetic (PK) data will be obtained for PBF-999.
The phase I dose expansion will consist of 1 group including immunotherapy naïve and pretreated (previous immune checkpoint inhibitors; anti-CTLA-4, anti-PD-1, anti-PD-L1 and/or combinations) solid tumors cancer patients. Pharmacodynamic (PD) data will be obtained for potential biomarker analysis with pre-treatment and on-treatment tumor biopsies.
Phase I Dose Escalation (3+3 Design):
Phase I Safety Expansion Once RP2D has been declared for PBF-999 using the standard 3+3 design, up to 20 additional solid tumor cancer patients may be treated at the RP2D to further explore safety and tolerability of the selected PBF-999 dose.
Patients in this study will be males or females 18 years of age or older. Patients must have histologically or cytologically confirmed cancer with at least one measurable lesion, with adequate organ and marrow function, and with ECOG performance status of 0-1. Eligible patients must have received at least one prior line of therapy for their disease.
Palobiofarma SL is the lead sponsor of 10 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: PBF-999
Drug: PBF-999
Drug: PBF-999
Drug: PBF-999
Drug: PBF-999
Phosphodiesterase 10 inhibitor (PDE10i)
Number of Adverse Events (AEs) graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
AEs will be described by system organ class and preferred tem using the Medical Dictionary for Regulatory Activities (MedDRA). Clinically relevant Laboratory abnormalities with toxicity grades according to the NCI CTCAE v4.03 will be derived and summarized.
Time frame: 28 Days
The Maximun Tolerated Dose (MTD) of PBF-999
The MTD evaluation will be based on the Dose-limiting Toxicity (DLT) of the treated Population and will include Adverse events (AEs), Serious Adverse events (SAEs) and laboratory evaluations. DLT Evaluable Population will be all patients enrolled in the dose-escalation portion of the trial, who receive the protocol-assigned treatment with PBF-999 and complete the safety follow-up through the DLT evaluation period or experience a DLT during the DLT evaluation period.
Time frame: 28 Days
Time to PBF-999 peak concentration in plasma "Tmax
The parameter will be calculated from plasma samples collected at days 1, day 8 and 29 after drug administration. It will consist in the time (in minutes) to reach the maximum "PBF-1129" concentration in plasma samples of patients after oral administration of PBF-999.
Time frame: Day 1, Day 8 and Day 29
PBF-999 peak concentration in plasma "Cmax"
The parameter will be calculated from plasma samples collected at days 1, 8 and 29 after drug administration. It will consist in the maximum plasma concentration (ng/mL) of PBF-999 observed after administration.
Time frame: Day 1, Day 8 and Day 29
The area under PBF-999 plasma concentration-time curve to infinite time "AUC(0-inf)
The parameter will be calculated from plasma samples collected at days 1, 8 and 29 after drug administration. It will consist in the area under the concentration-time curve from zero up to ∞ with extrapolation of the terminal phase. "AUC(0-inf)" will be given in Amount·time/ volume units
Time frame: Day 1, Day 8 and Day 29
PBF-999 half-life in plasma " t½"
The parameter will be calculated from plasma samples collected at days 1, 8 and 29 after drug administration. It will consist in the terminal half-life of PBF-999 in plasma. "t½" will be given in hours (h)
Time frame: Day 1, Day 8 and Day 29
Efficacy of PBF-999 treatment as measured by Objective response rate (ORR
ORR: Response and progression will be evaluated in this study using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1).ORR is defined as confirmed complete response (CR) or partial response (PR) based on modified RECIST v1.1.
Time frame: 2 years
Efficacy of PBF-999 as measured by Disease control rate (DCR)
The disease control rate (DCR) will be estimated considering the following variables: Complete response (CR), Partial response (PR) and stable disease (SD) as described by Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). These variables will be assessed based on Imaging-based evaluation methods as chest x-ray, conventional computed tomography (CT) and magnetic resonance imaging (MRI) that will be performed every 2 cycles of 28 days administration.
Time frame: 2 years
Efficacy of PBF-999 as measured by duration of response (DoR)
Duration of response (DoR) is defined as the duration from the first documentation of OR to the first documented disease progression or death due to any cause, whichever occurs first
Time frame: 2 years
Efficacy of PBF-999 as measured by progression-free survival (PFS)
Progression-free survival (PFS) will be measured from the start of treatment until the documentation of disease progression or death due to any cause, whichever occurs first. For subjects who are alive and progression-free at the time of data cut-off for analysis, PFS will be censored at the last tumor assessment date.
Time frame: 2 years
Efficacy of PBF-999 as measured by overall survival (OS)
Overall survival (OS) will be determined as the time from the start of treatment until death due to any cause
Time frame: 2 years
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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Palobiofarma SL