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

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Spain
Hospital Vall d´Hebrón
RECRUITING
Barcelona
ICO Hopsitalet
RECRUITING
L'hospitalet De Llobregat
Hospital Gregorio Marañon
RECRUITING
Madrid
Hospital Regional Universitario de Málaga
RECRUITING
Málaga
Hospital Universitario Marqués de Valdecilla
RECRUITING
Santander
Hospital Miguel Servet
RECRUITING
Zaragoza
Contact Information
Primary
Manuela Niewel, MD, PhD
mniewel@peptomyc.com
+34670327414
Backup
Pepi Morales, PhD
pmorales@peptomyc.com
+34654937746
Time Frame
Start Date: 2023-08-31
Estimated Completion Date: 2026-03-31
Participants
Target number of participants: 30
Treatments
Experimental: Nab-Paclitaxel+Gemcitabine+OMO-103
SoC Gemcitabine/Nab-Paclitaxel plus experimental OMO-103
Related Therapeutic Areas
Sponsors
Leads: Peptomyc S.L.

This content was sourced from clinicaltrials.gov