Spots Global Cancer Trial Database for Study to Evaluate the Safety, PK, and Efficacy of the Myc Inhibitor OMO-103 Administered iv in Patients With PDAC

Study Description

Brief Summary: 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.

Detailed Description: 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

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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