This study is an open-label, multicentre, Phase 1b trial designed to determine the safety, tolerability, efficacy, PK, pharmacodynamics (PD) and proof-of-concept of OMO-103 in combination with the standard regimen gemcitabine/nab-paclitaxel in patients with metastatic pancreatic cancer who are treatment-naïve in the advanced disease setting.
This study is an open-label, multicentre, Phase 1b trial designed to determine the safety, tolerability, efficacy, PK, pharmacodynamics (PD) and proof-of-concept of OMO-103 in combination with the standard regimen gemcitabine/nab-paclitaxel in patients with metastatic pancreatic cancer who are treatment-naïve in the advanced disease setting. The study consists of two parts: Part 1 (Safety-Run-In) in patients with metastatic pancreatic cancer, evaluating OMO-103 plus gemcitabine/nab-paclitaxel in two dose levels at 75% and 100% of the RP2D. Approximately six patients will be enrolled in Part 1, covering two dose levels with the primary objective of determining the safety and tolerability of OMO-103 plus gemcitabine/nab-paclitaxel and defining an appropriate dose for further evaluation in Part 2. Part 2 (Dose expansion) in patients with metastatic pancreatic cancer where gemcitabine/nab-paclitaxel is a suitable treatment option. Patients will be treated with the dose found in part 1 to further characterise the safety, tolerability, PK, PD and anti-tumour activity of this combination
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Investigational Product: 35 mg/mL (4.5 mL/vial) concentrate for solution for infusion
IV infusion - Standard of Care
IV infusion - Standard of Care
Hospital Vall d´Hebrón
Barcelona, Barcelona, Spain
ICO Hopsitalet
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain
Hospital Gregorio Marañon
Madrid, Madrid, Spain
Number of AEs, SAEs to evaluate the safety and tolerability of OMO-103 plus gemcitabine/nab-paclitaxel
To evaluate the safety and tolerability of OMO-103 plus gemcitabine/nab-paclitaxel in adult patients with metastatic pancreatic cancer being treatment naïve.
Time frame: through study completion, an average of 2 years
To assess the anti-tumour activity of OMO-103 plus gemcitabine/nab-paclitaxel as measured by objective response rate (ORR)
ORR, PFS, DCR, TTP, TTR, and DOR assessed via RECIST v1.1 criteria.
Time frame: through study completion, an average of 2 years
Ratio of patients with positive cytokine predictive signature result and its impact on efficacy
Predictive cytokine signature and its impact on efficacy (as above)
Time frame: through study completion, an average of 2 years
To assess the anti-tumour activity via 3D-volumetric measurement
Percentage of tumour burden change evaluated via 3D volumetric analysis of the total tumour burden.
Time frame: through study completion, an average of 2 years
Type, incidence, severity, timing, seriousness, and relatedness of AEs and laboratory
Type, incidence, severity, timing, seriousness, and relatedness of AEs and laboratory abnormalities.
Time frame: through study completion, an average of 2 years
To characterise the PK of OMO-103 plus gemcitabine/nab-paclitaxel
PK parameters of OMO-103 plus gemcitabine/nab-paclitaxel
Time frame: through study completion, an average of 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Hospital Regional Universitario de Málaga
Málaga, Spain, Spain
Hospital Miguel Servet
Zaragoza, Zaragoza, Spain
To assess the development of human ADAs to OMO-103.
Incidence of ADAs to OMO-103
Time frame: through study completion, an average of 2 years
To evaluate quality of life (QoL) in patients with metastatic pancreatic cancer
Scores on the validated European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) (version 3) and QLQ-PAN26 (EORTC PAN26) QLQ-PAN26: Scale with values from 1 to 4, where 4 is the most positive for the patient's quality of life. QLQ-C30: Scale with values from 1 to 4, where 1 is the most positive for the patient's quality of life.
Time frame: through study completion, an average of 2 years