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.
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
Drug | Synonyms | Arms |
---|
OMO-103 | | OMO-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
Name | Type | Description | Interventions |
---|
OMO-103 | Experimental | OMO-103 will be administered intravenously as 30 min infusion once weekly | |
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