Status:
COMPLETED
Study of PBF-999 in Solid Tumour Advanced Cancer
Lead Sponsor:
Palobiofarma SL
Collaborating Sponsors:
Vall d'Hebron institute of oncology (VHIO), Catalan institute of oncology (Hospitalet) (ICO)
Conditions:
Cancer
Eligibility:
All Genders
Phase:
PHASE1
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 ef...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2022
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT03786484
Start Date
October 1 2017
End Date
June 30 2022
Last Update
January 26 2023
Active Locations (1)
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1
Vall d'Hebron institute of oncology (VHIO)
Barcelona, Spain