search
Back to results

Study to Evaluate the Safety, PK, and Efficacy of the Myc Inhibitor OMO-103 Administered iv in Patients With PDAC (OMO-103-02)

Primary Purpose

Metastatic Pancreatic Cancer

Status
Recruiting
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
OMO-103
Nab-Paclitaxel
Gemcitabine
Sponsored by
Peptomyc S.L.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Pancreatic Cancer focused on measuring PDAC, Pancreatic cancer, metastatic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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: 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: True abstinence Male sterilisation Hormonal female contraceptive (oral, parenteral, intravaginal, implantable or transdermal) and condom Intrauterine contraceptive device and condom. Exclusion Criteria: Systemic anti-cancer therapy within four weeks prior to study drug administration. Radiation therapy within four weeks prior to study entry. Localised palliative radiotherapy to non-target lesions is allowed. Previous or concurrent malignancy that could affect compliance with the protocol or interpretation of results. Patients curatively treated more than 2 years prior to enrolment, and patients with adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ are eligible. Previous treatment with either gemcitabine or nab-paclitaxel in any setting. Contraindication to receive gemcitabine/nab-paclitaxel. Non-malignant systemic disease including cerebrovascular accident, unstable angina pectoris, unstable atrial fibrillation, unstable cardiac arrhythmia, myocardial infarction in the last six months, New York Heart Association (NYHA) Class III or IV heart failure. Patients with active uncontrolled infection or known to be serologically positive for human immunodeficiency virus (HIV), hepatitis B (except after vaccination) or hepatitis C infection. Investigators may test as per their discretion. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for entry into this study. Pregnant or nursing. Patients with symptomatic or unstable central nervous system primary tumour or metastases and/or carcinomatous meningitis. Live vaccine in the last four weeks. Current participation in another trial.

Sites / Locations

  • ICO HopsitaletRecruiting
  • Hospital Vall d´HebrónRecruiting
  • Hospital Gregorio MarañonRecruiting
  • Hospital Miguel ServetRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nab-Paclitaxel+Gemcitabine+OMO-103

Arm Description

SoC Gemcitabine/Nab-Paclitaxel plus experimental OMO-103

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Ratio of patients with positive cytokine predictive signature result and its impact on efficacy
Predictive cytokine signature and its impact on efficacy (as above)
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.
Type, incidence, severity, timing, seriousness, and relatedness of AEs and laboratory
Type, incidence, severity, timing, seriousness, and relatedness of AEs and laboratory abnormalities.
To characterise the PK of OMO-103 plus gemcitabine/nab-paclitaxel
PK parameters of OMO-103 plus gemcitabine/nab-paclitaxel
To assess the development of human ADAs to OMO-103.
Incidence of ADAs to OMO-103
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.

Full Information

First Posted
September 13, 2023
Last Updated
September 22, 2023
Sponsor
Peptomyc S.L.
search

1. Study Identification

Unique Protocol Identification Number
NCT06059001
Brief Title
Study to Evaluate the Safety, PK, and Efficacy of the Myc Inhibitor OMO-103 Administered iv in Patients With PDAC
Acronym
OMO-103-02
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 31, 2023 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
March 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peptomyc S.L.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Pancreatic Cancer
Keywords
PDAC, Pancreatic cancer, metastatic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nab-Paclitaxel+Gemcitabine+OMO-103
Arm Type
Experimental
Arm Description
SoC Gemcitabine/Nab-Paclitaxel plus experimental OMO-103
Intervention Type
Drug
Intervention Name(s)
OMO-103
Intervention Description
Investigational Product: 35 mg/mL (4.5 mL/vial) concentrate for solution for infusion
Intervention Type
Drug
Intervention Name(s)
Nab-Paclitaxel
Intervention Description
IV infusion - Standard of Care
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
IV infusion - Standard of Care
Primary Outcome Measure Information:
Title
Number of AEs, SAEs to evaluate the safety and tolerability of OMO-103 plus gemcitabine/nab-paclitaxel
Description
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
Secondary Outcome Measure Information:
Title
To assess the anti-tumour activity of OMO-103 plus gemcitabine/nab-paclitaxel as measured by objective response rate (ORR)
Description
ORR, PFS, DCR, TTP, TTR, and DOR assessed via RECIST v1.1 criteria.
Time Frame
through study completion, an average of 2 years
Title
Ratio of patients with positive cytokine predictive signature result and its impact on efficacy
Description
Predictive cytokine signature and its impact on efficacy (as above)
Time Frame
through study completion, an average of 2 years
Title
To assess the anti-tumour activity via 3D-volumetric measurement
Description
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
Title
Type, incidence, severity, timing, seriousness, and relatedness of AEs and laboratory
Description
Type, incidence, severity, timing, seriousness, and relatedness of AEs and laboratory abnormalities.
Time Frame
through study completion, an average of 2 years
Title
To characterise the PK of OMO-103 plus gemcitabine/nab-paclitaxel
Description
PK parameters of OMO-103 plus gemcitabine/nab-paclitaxel
Time Frame
through study completion, an average of 2 years
Title
To assess the development of human ADAs to OMO-103.
Description
Incidence of ADAs to OMO-103
Time Frame
through study completion, an average of 2 years
Title
To evaluate quality of life (QoL) in patients with metastatic pancreatic cancer
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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: 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: True abstinence Male sterilisation Hormonal female contraceptive (oral, parenteral, intravaginal, implantable or transdermal) and condom Intrauterine contraceptive device and condom. Exclusion Criteria: Systemic anti-cancer therapy within four weeks prior to study drug administration. Radiation therapy within four weeks prior to study entry. Localised palliative radiotherapy to non-target lesions is allowed. Previous or concurrent malignancy that could affect compliance with the protocol or interpretation of results. Patients curatively treated more than 2 years prior to enrolment, and patients with adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ are eligible. Previous treatment with either gemcitabine or nab-paclitaxel in any setting. Contraindication to receive gemcitabine/nab-paclitaxel. Non-malignant systemic disease including cerebrovascular accident, unstable angina pectoris, unstable atrial fibrillation, unstable cardiac arrhythmia, myocardial infarction in the last six months, New York Heart Association (NYHA) Class III or IV heart failure. Patients with active uncontrolled infection or known to be serologically positive for human immunodeficiency virus (HIV), hepatitis B (except after vaccination) or hepatitis C infection. Investigators may test as per their discretion. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for entry into this study. Pregnant or nursing. Patients with symptomatic or unstable central nervous system primary tumour or metastases and/or carcinomatous meningitis. Live vaccine in the last four weeks. Current participation in another trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Manuela Niewel, MD, PhD
Phone
+34670327414
Email
mniewel@peptomyc.com
First Name & Middle Initial & Last Name or Official Title & Degree
Pepi Morales, PhD
Phone
+34654937746
Email
pmorales@peptomyc.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teresa Macarulla, MD, PhD
Organizational Affiliation
Hospital Vall d´Hebrón
Official's Role
Principal Investigator
Facility Information:
Facility Name
ICO Hopsitalet
City
L´Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08908
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mariona Calvo Campos, Physician
Email
mcalvo@iconcologia.net
Facility Name
Hospital Vall d´Hebrón
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Teresa Macarulla, Physician
Email
tmacarulla@vhio.net
Facility Name
Hospital Gregorio Marañon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrés Muñoz, Physician
Email
andresmunmar@hotmail.com
Facility Name
Hospital Miguel Servet
City
Zaragoza
ZIP/Postal Code
5009
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roberto Pazo Cid, Physician
Email
rpazo@salud.aragon.es

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study to Evaluate the Safety, PK, and Efficacy of the Myc Inhibitor OMO-103 Administered iv in Patients With PDAC

We'll reach out to this number within 24 hrs