A Phase 1b Study to Evaluate the Safety, Pharmacokinetics, and Anti-Tumour Activity of the Myc Inhibitor OMO-103 Administered Intravenously in Patients with Advanced Solid Tumours
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.
• 1\. Male or female patients, 18 years of age or older who sign the ICF and are willing and able to comply with the study protocol.
• 2\. Histologically or cytologically proven pancreatic cancer (pancreatic ductal adenocarcinoma \[PDAC\]).
• 3\. Patients have to be treatment naïve in the metastatic setting (neo-or adjuvant treatment has to be finished at least six months before) and are suitable to receive the standard regimen gemcitabine and nab-paclitaxel.
• 4\. Patients must show a specific biomarker signature, which will be analysed before inclusion into the study, comprising CD62E, MIP-1ß, MCP-1 and IL-8.
• 5\. Patients must have measurable disease as per RECIST v1.1 criteria and documented by computed tomography (CT) and/or magnetic resonance imaging (MRI). NOTE: Lesions to be used as measurable disease for the purpose of response assessment must either:
⁃ not reside in a field that has been subjected to prior radiotherapy, or
⁃ have demonstrated clear evidence of radiographic progression since the completion of prior radiotherapy and prior to study enrolment.
‣ 6\. Tumour biopsy (either from the primary tumour or from metastases) during Screening and during Treatment should be obtained from the patients. NOTE: In case a patient has had a tumour biopsy in the previous 6 months and a paraffin block is available, a new biopsy does not need to be done at Screening.
‣ 7\. For each patient undergoing pre- and on-treatment biopsies, the identified lesion to be biopsied should not have been previously irradiated and should not be the only lesion being utilised as a measurable-disease target lesion for objective response assessment. Patients must have tumour lesions that can be accessed for biopsy with acceptable clinical risk in the judgement of the Investigator.
‣ 8\. ECOG performance status up to 1. 9. Adequate organ function as defined by the following criteria:
‣ Haematological:
‣ o Neutrophils ≥1,500/μL
‣ o Platelets ≥100,000/μL
∙ Haemoglobin ≥10 g/dL
‣ Renal:
‣ o Creatinine Clearance (calculated via Cockcroft-Gault Equation) ≥50 mL/min
‣ Hepatic:
‣ o Serum total bilirubin ≤1.5 upper limit of normal (ULN) or
‣ o Direct bilirubin ≤ULN for patients with total bilirubin \>1.5 ULN
‣ o Aspartate aminotransferase/serum glutamic-oxaloacetic transaminase (AST/SGOT) and alanine aminotransferase/serum glutamic-pyruvic transaminase (ALT/SGPT) ≤2.5 ULN or ≤5 ULN if liver metastases
‣ Chemistry:
∙ Albumin \>30 g/L. 10. If not postmenopausal or surgically sterile, female patients must be willing to practice at least one of the following highly effective methods of birth control (defined as having a low failure rate) for at least a menstrual cycle before and for 1 month after last study drug administration:
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‣ True abstinence, when this is in line with the preferred and usual lifestyle of the patient, from sexual intercourse with a member of the opposite sex;
⁃ Sexual intercourse with vasectomised male;
⁃ Hormonal female contraceptive (oral, parenteral, intravaginal, implantable or transdermal) for at least 3 consecutive months prior to investigational product administration (when not clinically contraindicated as in breast, ovarian and endometrial cancers);
⁃ Use of an intrauterine contraceptive device. 11. Male patients and their sexual partners must use an appropriate contraceptive from Screening for 6 months after last study drug administration, including:
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‣ True abstinence
⁃ Male sterilisation
⁃ Hormonal female contraceptive (oral, parenteral, intravaginal, implantable or transdermal) and condom
⁃ Intrauterine contraceptive device and condom.