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

• ClinicalTrials.gov Identifier: NCT04808362
• Recruitment Status: Active, not recruiting
• First Posted: March 22, 2021
• Last Update Posted: September 28, 2022
• Sponsor: Peptomyc S.L.
• Information provided by (Responsible Party): Peptomyc S.L.

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.

Condition or disease	Intervention/treatment	Phase
Advanced Solid Tumors; NSCLC; Triple-negative Breast Cancer; CRC	Biological: OMO-103	Phase 1; Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 22 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: accelerated titration design
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: April 28, 2021
• Estimated Primary Completion Date: August 2024
• Estimated Study Completion Date: December 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: OMO-103; OMO-103 will be administered intravenously as 30 min infusion once weekly	Biological: OMO-103; OMO-103 will be administered intravenously as 30 min infusion once weekly

Outcome Measures

Primary Outcome Measures :

1. Phase 1: Number of patients with treatment related AEs according to NCI CTCAE v 5 [ Time Frame: 3 weeks ]
2. Phase 2: Objective Response Rate (ORR) according to RECIST 1.1 [ Time Frame: 18 weeks ]

Secondary Outcome Measures :

1. Phase 1: Objective Response Rate (ORR) according to RECIST 1.1 [ Time Frame: 9 weeks ]
2. 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 ]
   Pharmacokinetics of OMO-103
3. 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 ]
4. 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 ]
5. 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 ]
6. 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 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Spain

University Hospital Vall d´Hebron

Barcelona, Spain, 08035

Hospital Fundación Jiménez Díaz

Madrid, Spain, 28050

Hospital Universitario HM Sanchinarro

Madrid, Spain, 28050

Sponsors and Collaborators

Peptomyc S.L.

Investigators

• Principal Investigator: Elena Garralda, MD, PhD; University Hospital Vall d´Hebron; Oncology Department

More Information

• Responsible Party: Peptomyc S.L.
• ClinicalTrials.gov Identifier: NCT04808362
• Other Study ID Numbers: OMO-103-01
• First Posted: March 22, 2021
• Last Update Posted: September 28, 2022
• Last Verified: July 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Peptomyc S.L.:

MYC-Inhibitor; First in human; solid tumor

Additional relevant MeSH terms:

Triple Negative Breast Neoplasms; Neoplasms; Breast Neoplasms; Neoplasms by Site; Breast Diseases; Skin Diseases