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: Terminated
• First Posted: March 22, 2021
• Results First Posted: April 25, 2024
• Last Update Posted: April 25, 2024
• Sponsor: Peptomyc S.L.
• Information provided by (Responsible Party): Peptomyc S.L.

Tracking Information

• First Submitted Date: March 16, 2021
• First Posted Date: March 22, 2021
• Results First Submitted Date: October 16, 2023
• Results First Posted Date: April 25, 2024
• Last Update Posted Date: April 25, 2024
• Actual Study Start Date: April 28, 2021
• Actual Primary Completion Date: December 15, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 23, 2024)

Phase 1: Safety and Tolerability [ Time Frame: DLT period was 3 weeks and AEs were assessed for each patient until progression which was in average 3 months; ]

Phase 1: Number of patients with a DLT; Number of patients with IRRs, AEs /SAEs according to NCI CTCAE v 5;

Original Primary Outcome Measures (submitted: March 18, 2021)

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

Current Secondary Outcome Measures (submitted: April 23, 2024)

Phase 1: Elimination Half Life (t1/2) [ Time Frame: 0, 5, 30, 60 min, 1, 2, 6, 24, 48, 76, 94 hours after end of infusion ]

Phase 1: elimination half life (t1/2) was determined via several timepoints from 0 up to 94 hours after end of infusion

Original Secondary Outcome Measures (submitted: March 18, 2021)

• Phase 1: Objective Response Rate (ORR) according to RECIST 1.1 [ Time Frame: 9 weeks ]
• 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
• 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 ]
• 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 ]
• 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 ]
• 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 ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.

• Study Type: Interventional
• Study Phase: Phase 1; Phase 2

Study Design

Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

accelerated titration design

Masking: None (Open Label)
Primary Purpose: Treatment

Condition

• Advanced Solid Tumors
• Pancreatic Cancer
• CRC

Intervention

Biological: OMO-103

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

Study Arms

Experimental: OMO-103

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

Intervention: Biological: OMO-103

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: September 27, 2022): 22
• Original Estimated Enrollment (submitted: March 18, 2021): 74
• Actual Study Completion Date: January 11, 2023
• Actual Primary Completion Date: December 15, 2022 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Spain

Administrative Information

• NCT Number: NCT04808362
• Other Study ID Numbers: OMO-103-01
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Peptomyc S.L.
• Original Responsible Party: Same as current
• Current Study Sponsor: Peptomyc S.L.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Peptomyc S.L.
• Verification Date: April 2024