NCT03786484

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P50-P75 for phase_1 cancer

Timeline
Completed

Started Oct 2017

Longer than P75 for phase_1 cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2017

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 20, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 26, 2018

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

January 26, 2023

Status Verified

January 1, 2022

Enrollment Period

4.7 years

First QC Date

December 20, 2018

Last Update Submit

January 24, 2023

Conditions

Cancer

Keywords

solid tumorsPDE10 inhibitorsImmunoncology

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    28 Days

Secondary Outcomes (9)

  • Time to PBF-999 peak concentration in plasma "Tmax

    Day 1, Day 8 and Day 29

  • PBF-999 peak concentration in plasma "Cmax"

    Day 1, Day 8 and Day 29

  • The area under PBF-999 plasma concentration-time curve to infinite time "AUC(0-inf)

    Day 1, Day 8 and Day 29

  • PBF-999 half-life in plasma " t½"

    Day 1, Day 8 and Day 29

  • Efficacy of PBF-999 treatment as measured by Objective response rate (ORR

    2 years

  • +4 more secondary outcomes

Study Arms (5)

PBF-999 20 mg

EXPERIMENTAL
Drug: PBF-999

PBF-999 40 mg

EXPERIMENTAL
Drug: PBF-999

PBF-999 80 mg

EXPERIMENTAL
Drug: PBF-999

PBF-999 120 mg

EXPERIMENTAL
Drug: PBF-999

recommended phase 2 dose (RP2D)

EXPERIMENTAL
Drug: PBF-999

Interventions

PBF-999DRUG

Phosphodiesterase 10 inhibitor (PDE10i)

PBF-999 120 mgPBF-999 20 mgPBF-999 40 mgPBF-999 80 mgrecommended phase 2 dose (RP2D)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vall d'Hebron institute of oncology (VHIO)

Barcelona, Spain

Location

MeSH Terms

Conditions

Neoplasms

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2018

First Posted

December 26, 2018

Study Start

October 1, 2017

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

January 26, 2023

Record last verified: 2022-01

Locations

ES(1)