Advanced Solid Tumors, CRC, Pancreatic Cancer
Conditions
Keywords
MYC-Inhibitor, First in human, solid tumor
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.
Interventions
BIOLOGICALOMO-103
OMO-103 will be administered intravenously as 30 min infusion once weekly
Sponsors
Peptomyc S.L.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
accelerated titration design
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1: Safety and Tolerability | 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; |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1: Elimination Half Life (t1/2) | 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 |
Countries
Spain
Participant flow
Recruitment details
22 patients at 3 sites
Participants by arm
| Arm | Count |
|---|---|
| OMO-103 OMO-103 will be administered intravenously as 30 min infusion once weekly | 22 |
| Total | 22 |
Baseline characteristics
| Characteristic | OMO-103 |
|---|---|
| Age, Continuous | 61 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 22 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 22 Participants |
| Region of Enrollment Spain | 22 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 22 |
| other Total, other adverse events | 22 / 22 |
| serious Total, serious adverse events | 9 / 22 |
Outcome results
Primary
Phase 1: Safety and Tolerability
Phase 1: Number of patients with a DLT; Number of patients with IRRs, AEs /SAEs according to NCI CTCAE v 5;
Time frame: DLT period was 3 weeks and AEs were assessed for each patient until progression which was in average 3 months;
Population: safety population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| OMO-103 | Phase 1: Safety and Tolerability | DLT DLT | 1 participants |
| OMO-103 | Phase 1: Safety and Tolerability | TEAEs | 18 participants |
| OMO-103 | Phase 1: Safety and Tolerability | SAEs | 9 participants |
| OMO-103 | Phase 1: Safety and Tolerability | IRRs | 10 participants |
Secondary
Phase 1: Elimination Half Life (t1/2)
Phase 1: elimination half life (t1/2) was determined via several timepoints from 0 up to 94 hours after end of infusion
Time frame: 0, 5, 30, 60 min, 1, 2, 6, 24, 48, 76, 94 hours after end of infusion
Population: Safety population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OMO-103 | Phase 1: Elimination Half Life (t1/2) | 38 hours | Standard Deviation 19 |