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

Primary Purpose

Advanced Solid Tumors, NSCLC, Triple-negative Breast Cancer

Status

Active

Phase

Phase 1

Locations

Spain

Study Type

Interventional

Intervention

OMO-103

About this trial

This is an interventional treatment trial for Advanced Solid Tumors focused on measuring MYC-Inhibitor, First in human, solid tumor

Eligibility Criteria

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

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.

Sites / Locations

University Hospital Vall d´Hebron
Hospital Fundación Jiménez Díaz
Hospital Universitario HM Sanchinarro

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

OMO-103

Arm Description

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

Outcomes

Primary Outcome Measures

Phase 1: Number of patients with treatment related AEs according to NCI CTCAE v 5

Phase 2: Objective Response Rate (ORR) according to RECIST 1.1

Secondary Outcome Measures

Phase 1: Objective Response Rate (ORR) according to RECIST 1.1

Phase 1 & 2: area under the curve (AUC)

Pharmacokinetics of OMO-103

Phase 1 & 2: minimum concentration (Cmin)

Phase 1 & 2: maximum concentration (Cmax)

Phase 1 & 2: elimination half life (t1/2)

Phase 1 & 2: time to reach Cmax (tmax)

Full Information

NCT ID

NCT04808362

First Posted

March 16, 2021

Last Updated

September 27, 2022

Sponsor

Peptomyc S.L.

1. Study Identification

Unique Protocol Identification Number

NCT04808362

Brief Title

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

Acronym

MYCure

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

April 28, 2021 (Actual)

Primary Completion Date

August 2024 (Anticipated)

Study Completion Date

December 2024 (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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

MYC-Inhibitor, First in human, solid tumor

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Model Description

accelerated titration design

Masking

None (Open Label)

Allocation

N/A

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

OMO-103

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

OMO-103

Intervention Description

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

Primary Outcome Measure Information:

Title

Phase 1: Number of patients with treatment related AEs according to NCI CTCAE v 5

Time Frame

3 weeks

Title

Phase 2: Objective Response Rate (ORR) according to RECIST 1.1

Time Frame

18 weeks

Secondary Outcome Measure Information:

Title

Phase 1: Objective Response Rate (ORR) according to RECIST 1.1

Time Frame

9 weeks

Title

Phase 1 & 2: area under the curve (AUC)

Description

Pharmacokinetics of OMO-103

Time Frame