Clinical Trials /

Phase 1/2 Study to Evaluate Safety, PK and Efficacy of the MYC-Inhibitor OMO-103 in Solid Tumours

NCT04808362

Description:

This study is an open label, two-part, First in Human (FIH) Phase 1/2 dose-finding study designed to determine the safety, tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD) and proof-of-concept (POC) of OMO-103 in patients with advanced solid tumours.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Phase 1/2 Study to Evaluate Safety, PK and Efficacy of the MYC-Inhibitor OMO-103 in Solid Tumours
  • Official Title: A Phase 1/2 Study to Evaluate the Safety, Pharmacokinetics, and Anti-Tumour Activity of the MYC Inhibitor OMO-103 Administered Intravenously in Patients With Advanced Solid Tumours

Clinical Trial IDs

  • ORG STUDY ID: OMO-103-01
  • NCT ID: NCT04808362

Conditions

  • Advanced Solid Tumors
  • NSCLC
  • Triple-negative Breast Cancer
  • CRC

Interventions

DrugSynonymsArms
OMO-103OMO-103

Purpose

This study is an open label, two-part, First in Human (FIH) Phase 1/2 dose-finding study designed to determine the safety, tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD) and proof-of-concept (POC) of OMO-103 in patients with advanced solid tumours.

Detailed Description

      This study is an open label, two-part, FIH Phase 1/2 dose-finding study designed to determine
      the safety, tolerability, PK, PD and proof-of-concept of OMO-103 in patients with advanced
      solid tumours.

      The study consists of two parts:

      • Part 1: Dose escalation in patients with advanced solid tumours, including 5 OMO-103 dose
      levels.

      Approximately 11 to 24 patients in total will be enrolled in Part 1, covering 5 dose levels
      with the primary objective of determining the safety and tolerability of OMO-103 and defining
      an appropriate dose for further evaluation in Part 2.

      The study will start with an accelerated-titration dose-escalation scheme enrolling one
      evaluable patient per cohort for the first 2 dose levels followed by a classic 3+3 design.

      • Part 2: Dose expansion where at least 3 parallel groups of patients with advanced Non Small
      Cell Lung Cancer (NSCLC), Triple Negative Breast Cancer (TNBC) and Colorectal Cancer (CRC)
      will be treated at the recommended Phase 2 dose (RP2D) of OMO-103 to further characterise the
      safety, tolerability, PK, PD and anti-tumour activity of OMO-103.

      Approximately 18 patients will be enrolled in each of the 3 parallel groups of patients
      (NSCLC, TNBC, CRC) in Part 2.
    

Trial Arms

NameTypeDescriptionInterventions
OMO-103ExperimentalOMO-103 will be administered intravenously as 30 min infusion once weekly
  • OMO-103

Eligibility Criteria

        Main Inclusion Criteria:

        - Male or female patients, 18 years of age or older who sign the informed consent document,
        are willing and able to comply with the study protocol and have:

        Part 1 (Dose Escalation):

        - Histologically or cytologically proven advanced solid tumour for which there is no
        curative therapy and has progressed on Standard of Care (SOC) treatment or is intolerant to
        or has no available SOC or SOC unacceptable.

        Part 2 (Dose Expansion):

        - Histologically or cytologically proven advanced NSCLC whose tumours are KRAS-mutated and
        where the disease has progressed after a chemotherapy and immunotherapy regimen (at least
        two prior lines of standard therapy), advanced TNBC where the disease has progressed after
        having received anthracyclines and taxanes (at least two prior lines of standard therapy)
        and advanced CRC whose tumours are RAS mutated and where the disease has progressed after
        at least two prior lines of standard therapy.

        Parts 1 and 2:

          -  Patient must have measurable disease as per RECIST v1.1 criteria

          -  Tumour biopsy (either from the primary tumour or from metastases) during Screening and
             during Treatment should be obtained from the patients, if feasible.

          -  Documented progression on or following the last line of therapy.

          -  ECOG performance status up to 1.

          -  Life expectancy of ≥12 weeks.

          -  Adequate organ function

        Main Exclusion Criteria:

        Parts 1 and 2:

          -  Systemic anti-cancer therapy within 4 weeks prior to study entry.

          -  Radiation therapy within 4 weeks prior to study entry. Localised palliative
             radiotherapy to non-target lesions is allowed.

          -  Non-malignant systemic disease including cerebrovascular accident (CVA), unstable
             angina pectoris, unstable atrial fibrillation, unstable cardiac arrhythmia, myocardial
             infarction in the last 6 months, New York Heart Association (NYHA) Class III or IV
             heart failure, coagulation abnormalities and clinically significant pulmonary
             compromise, particularly a requirement for supplemental oxygen use to maintain
             adequate oxygenation in the previous 6 months.

          -  Patients with a history of congenital or acquired immunodeficiency syndrome, or
             currently receiving immunosuppressive therapy >10 mg prednisolone or equivalent.
             Patients receiving inhaled or topical corticosteroids are eligible.

          -  Patients with symptomatic or unstable central nervous system (CNS) primary tumour or
             metastases and/or carcinomatous meningitis. Patients with documented treated CNS
             metastases stable for at least 4 weeks may be enrolled at the discretion of the
             Investigator.

          -  Patients with need of therapeutic anticoagulation.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Phase 1: Number of patients with treatment related AEs according to NCI CTCAE v 5
Time Frame:3 weeks
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Phase 1: Objective Response Rate (ORR) according to RECIST 1.1
Time Frame:9 weeks
Safety Issue:
Description:
Measure:Phase 1 & 2: area under the curve (AUC)
Time Frame:0, 5, 30, 60 min, 1, 2, 6, 24, 48, 76, 94 hours after end of infusion
Safety Issue:
Description:Pharmacokinetics of OMO-103
Measure:Phase 1 & 2: minimum concentration (Cmin)
Time Frame:0, 5, 30, 60 min, 1, 2, 6, 24, 48, 76, 94 hours after end of infusion
Safety Issue:
Description:
Measure:Phase 1 & 2: maximum concentration (Cmax)
Time Frame:0, 5, 30, 60 min, 1, 2, 6, 24, 48, 76, 94 hours after end of infusion
Safety Issue:
Description:
Measure:Phase 1 & 2: elimination half life (t1/2)
Time Frame:0, 5, 30, 60 min, 1, 2, 6, 24, 48, 76, 94 hours after end of infusion
Safety Issue:
Description:
Measure:Phase 1 & 2: time to reach Cmax (tmax)
Time Frame:0, 5, 30, 60 min, 1, 2, 6, 24, 48, 76, 94 hours after end of infusion
Safety Issue:
Description:

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Peptomyc S.L.

Trial Keywords

  • MYC-Inhibitor
  • First in human
  • solid tumor

Last Updated

May 7, 2021