Study of PBF-999 in Solid Tumour Advanced Cancer

• Status: Recruiting
• Trial end date: 2022-02-25
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Palobiofarma SL
• Collaborator: Vall d'Hebron institute of oncology (VHIO), Catalan institute of oncology (Hospitalet) (ICO)

Criteria

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.